1

EBP: Diet and Exercise Achieves Better Glycemic Control Than Drug Therapy in Patients
with Type 2 Diabetes

Lauren Kegelmyer, Ashley Kovac, Chinielle Lamey, & Heather Lee

Walsh University
NURS 702: Advanced Nursing Research
Shelly Amato-Curran PHD, APRN-CNS, CRRN, CNRN
October 5th, 2022
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EBP: Diet and Exercise Achieve Better Glycemic Control Than Drug Therapy in Patients
with Type 2 Diabetes
Type 2 diabetes is a common endocrine disorder that is characterized by insulin

resistance which is a public health concern in the United States (Abera et al., 2022). The

prevalence of type 2 diabetes is steadily increasing causing a significant physical and financial

burden on patients and their loved ones. Initial treatment for type 2 diabetes is lifestyle

interventions including diet, exercise, and weight loss prior to pharmacological therapy

(Johansen et al., 2017). Lifestyle interventions have been proven to decrease the risk of type 2

diabetes as well as being cost-effective alternatives to drug therapy. The American Diabetes

Association stresses lifestyle interventions for management of type 2 diabetes, but most patients

are unmotivated to incorporate them into their daily life which leads to providers prescribing

pharmacological therapy (Johansen et al., 2017). Antidiabetic medications and lifestyle

interventions can achieve glycemic control with decreased blood glucose as well as hemoglobin

A1c levels, a biomarker for diabetes, which should be less than 7. The problems with prescribing

pharmacological therapy are the negative side effects including drug interactions, physical

discomfort, increased cost, and decreased quality of life. (Johansen et al., 2017). Providers may

need multiple oral antihyperglycemic medications to achieve glycemic control which may be

costly for patients, which is why early implementation of lifestyle interventions into care can be

an alternative to pharmacological therapy.

Diet and exercise have been shown to decrease the incidence of type 2 diabetes and the

need for antidiabetic medications. These lifestyle interventions are not only less costly but can

decrease the risk of cardiovascular disease (Johansen et al., 2017). There is a lack of studies that

support the hypothesis that diet and exercise can be more beneficial for achieving adequate

glycemic control over pharmacological therapy as providers are more likely to use
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antihyperglycemic drugs for type 2 diabetes (Esponsito et al., 2009). Therefore, our purpose of

this study was to test the hypothesis if diet and exercise compared to drug therapy achieves better

glycemic control.

PICO Question
In patients with type II diabetes, does diet and exercise compared to drug therapy achieve

better glycemic control?

Current Use of Research Findings

After examining the findings of all the research articles (see Appendix), the group examined the

effects of diet and exercise compared to pharmacological therapy in the management of type 2

diabetes. Our results find that lifestyle interventions, in terms of diet and exercise, can

significantly improve glycemic control by reducing hemoglobin A1c levels and plasma glucose

levels of patients with type 2 diabetes (Lynch et al., 2019). Their use can reduce the dosage or

stop the use of antidiabetic medications after 6 to 12 months of adherence. Thus, taking part in

diet and exercise can lead to remission of type 2 diabetes which cannot be done with

pharmacological therapy alone (Dave et al., 2017). The best chance of achieving better glycemic

control with lifestyle interventions is seen early on within 1 year of established diagnosis so

timing is crucial (Dave et al., 2017). There is less of an effect in older patients who have been

diagnosed for a longer duration and who have poorer glycemic control with hemoglobin A1c

more than 8%. In these cases, pharmacological therapy is necessary for glycemic control, but

lifestyle interventions can be used as supplemental treatment (Sanghani et al., 2013).

Patients with type 2 diabetes who take part in healthy lifestyles are more likely to have

better glycemic control (Abera et al., 2022). Although patients are least likely to adhere to

lifestyle interventions due to lack of motivation, oral glycemic agents are associated with less
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compliance especially for patients who use insulin. Patients who take oral antidiabetic

medications like Metformin are less likely to be compliant which decreases their glycemic

control (Sampson et al., 2021). Type 2 diabetics needing insulin have even poorer glycemic

control that may be due to fear of needles, improper storage, and inconvenience of insulin use

(Afroz et al., 2019). Insulin users are more likely to have severe complications of diabetes which

requires intensive treatment. Exercise after eating has been found to be equivalent to mealtime

insulin in improving glycemic control in terms of reducing hemoglobin A1c levels

(Suntornlohanakul et al., 2020). Type 2 diabetics that exercise and have been supplied diet

counseling can improve their glycemic control even on insulin therapy. Patients who decide to

implement lifestyle changes for glycemic control must continue to take part and be motivated in

their care for remission of type 2 diabetes to continue (Pot et al., 2019). Education of lifestyle

interventions must be individualized for each patient to continue motivating them to be involved

in their care. As a result of lifestyle interventions, patients lose weight which is a significant risk

factor for type 2 diabetes (Dixit et al., 2022). Weight loss of 5-10% attributes to improved

glycemic control with decreased hemoglobin A1c and cholesterol levels. A low carbohydrate and

Mediterranean diet can lead to greater weight loss and improved glycemic control (Esposito et

al., 2009). Implementing this type of diet along with an intensive exercise regimen in newly

diagnosed patients with type 2 diabetes can delay the need for pharmacological therapy. In terms

of exercise, patients who adhere to structured exercise and higher levels of exercise are more

likely to improve their glycemic control compared to standard care of diabetes (Sampson et al.,

2021).

Lifestyle interventions have been overlooked as first-line agents for the treatment of type

2 diabetes as providers are guided by evidence-based practice that stresses the importance of

pharmacological therapy (Esposito et al., 2009). It is well known that diet and exercise is the
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first-line intervention of type 2 diabetes based on the researchers’ earlier experience in nursing

school and during the nurse practitioner program. In terms of personal connections, an

endocrinologist nurse practitioner at Aultman Hospital does stress the importance of lifestyle

interventions to her newly diagnosed patients (M. Baker, personal communication, September

2022). For patients who have had type 2 diabetes for a long time, it can be too late to implement

diet and exercise effectively into their care. She sees patients in the hospital who mostly have

poor glycemic control that need to be managed with oral antidiabetic medications or insulin (M.

Baker, personal communication, September 2022). Her care team has a diabetic educator who

specifically educates the patients on self-care management at home, which is extremely

beneficial. Speaking with a registered dietician who cares for many diabetic patients, he is not as

aware if diet has an impact on glycemic control for patients with type 2 diabetes (R. Averell,

personal communication, September 2022). He was taught in his nutrition program about the

importance of a diabetic or low-carbohydrate diet for patients with diabetes but not the effect on

glucose levels. However, he does report that most patients are non-complaint with diet which can

worsen their health outcomes (R. Averell, personal communication, September 2022). These

experiences show that healthcare professionals are trying to implement diet and exercise into

practice, but patients do not always utilize them in daily life.

Healthcare is a field that is ever-changing, thus requiring frequent adjustments in the

educational role of staff and students. This includes the education that is provided throughout

nursing school and throughout orientation. H. Steko (personal communication, 2022) just

recently graduated with her BSN and is now newly working on a medical surgical floor. She

states that her nursing program educated students on diabetes management, focusing largely on

type 1 diabetes. Students were taught the importance of lifestyle modifications including weight

loss, diet and exercise. However, H. Steko (personal communication, 2022) reports that she did
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not realize the impact that lifestyle modifications can have on those with type-2 diabetes in

potentially preventing the need for oral antihyperglycemic medication. Lifestyle interventions

are only incorporated briefly into advanced nursing practice, but emphasis is given on

pharmacological therapy (Cash & Glass, 2019). After speaking with a recent graduate of the FNP

program and has started a position as a nurse practitioner, he mentioned that there were few

assignments that stressed the importance of lifestyle interventions for treatment of type 2

diabetes (D. Bruce, personal communication, September 2022). A particular case study in FNP V

that he talked about involves a complex patient with uncontrolled diabetes with multiple

comorbidities. He is already on metformin 500 mg BID but should be increased to 1000 mg BID.

For non-pharmacological treatment, he mentioned that he spoke about lifestyle modifications

including weight loss, exercise, and diet but stressed the need for pharmacological therapy (D.

Bruce, personal communication, September 2022).

The ethical consideration of the findings is that lifestyle interventions are cost-effective

and can positively affect the health of all populations by preventing cardiovascular disease and

diabetes-related complications (Dave et al., 2017). Implementing diet and exercise into daily life

can lead to greater weight loss and decreased risk of type 2 diabetes. Lifestyle interventions may

lead to remission where pharmacological therapy will be used as continued management for type

2 diabetes (Johansen et al., 2017). Although diet and exercise can be effective in ensuring

glycemic control for some patients, it is not always for everyone. It may be challenging to

implement lifestyle interventions for minority groups from underserved populations as well as

low-income patients (Lynch et al., 2019). These patients are more at risk for cardiovascular

factors that increase the risk of type 2 diabetes and poorer glycemic control that may only be

effective with pharmacological therapy. Populations that are stressed with food insecurity,

violence, stress, poverty, and unsafe areas for recreational activities are less likely to partake in
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diet and exercise (Lynch et al., 2019). However, pharmacological therapy can be more

challenging as it can lead to poorer compliance due to increased costs, placing them at higher

risk for diabetes-related complications. Social support is necessary to implement lifestyle

interventions for patients with low socioeconomic status (Rajput et al., 2022). It was found that

by implementing diet and exercise that individualized to patient’s cultural and spiritual needs,

they are more likely to continue to implement them into their care.

Recommendations for Nursing Practice

The findings of the studies (see Appendix) are truly relevant to nursing practice. During

our literature research, some of our articles are older as we were unable to find many articles that

were relevant to our PICO question in the past 5 years. All our articles supplied sufficient

evidence to prove lifestyle interventions are effective for glycemic control. The study conducted

by Sampson et al. (2019) showed that with peer volunteer support better glycemic control can be

achieved by implementing diet and exercise for managing type 2 diabetes. This can be translated

into nursing practice because nurses are in a unique position to have a more active role in

improving glycemic control by supporting diabetic patients with healthy eating and lifestyle

interventions. Our literature search concluded that lifestyle interventions are a cheap and

effective alternative that should be promoted by nurses as an important intervention for

improving glycemic control (Dixit et al., 2022).

In the primary care setting, telemedicine or phone calls can be used by nurses to supply

support to diabetics and motivate them through their journey. Education and counselling are vital

for the implementation of lifestyle interventions as it can improve glycemic control without the

use of medications (Kim et al., 2013). Nurses can help patients to set personal glycemic goals

and educate on healthy lifestyle interventions such as diet and exercise. This recommendation is

supported by Abera et al. (2022) whose study found that poorer and inadequate glycemic control
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was associated with poor diet compliance and failure to set goals. Using nutritional therapy and

counseling improves glycemic control thereby decreasing hospitalization rate and improving

clinical outcomes (Avedzi et al., 2021). However, follow-up appointments are essential to prove

that the patients are continually adhering to the lifestyle modifications.

According to Martos-Cabrera et al. (2021), an educational program instructing diabetic

patients on self-care including healthy eating patterns, exercise and other self-management

education can help patients to improve and support good glycemic control. This educational

intervention must consider the patient’s level of understanding so that information is tailored to

the patient. There is sufficient evidence to show that intensive educational programs led by

nurses foster patients’ self-management and effective communication lead to lower HbA1C

levels (Martos-Cabrera et al., 2021). Many patients follow the recommended lifestyle

interventions for the first couple of months and then get demotivated. A proper multidisciplinary

intervention involves support groups and completing follow-ups via telephone or electronic

means. Follow up, whether via telemedicine or face-to-face, is also an important primary

outcome measure to assess if patients are following the recommended guidelines, an opportunity

to educate patients on updated guidelines and to evaluate if the intervention is effective (Martos-

Cabrera et al., 2021). These appointments would include assessing HbA1c levels at the

recommended intervals, assessing blood glucose levels, dietary intake, and exercise level. This

would be how providers can test the effectiveness of patient outcomes by assessing glycemic

control. Patients with a shorter duration of diabetes, long life expectancy and no significant

cardiovascular disease should have tighter glycemic control so the HbA1c goal should be 6.5%

or less (Abera et al., 2022). Conversely, people with a lower life expectancy, those with frequent

hypoglycemic episodes, significant comorbidities and advanced micro and macrovascular

complications should have less stringent goals of HbA1c up to 8%.

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Recommendations for Future Research

There are various recommendations for future research based off our studies. One

recommendation is to study more pharmacological therapy compared to lifestyle interventions

(Kim et al., 2013). More studies are needed to focus long-term on glycemic control and lifestyle

modifications when oral antihyperglycemic therapy fails. There are not very many primary

sources for this topic that are recent in the last five years so more research is needed in this area.

A second recommendation is to study a larger population of participants to increase the

generalizability of the topic (Johansen et al., 2017). A suitable sample proves that the research is

more efficient, the data produced is dependable, and resource funding is as restricted as possible

while following ethical principles (Faber & Fonseca, 2014).

Many of our studies used self-reported data which contributes to participant bias. It is

recommended to use different research measurements such as objective dietary and physical

activity measures to reduce bias (Kim et al., 2013). Bias in research can cause contorted results,

wrong conclusions, unnecessary costs, wrong clinical practice and can eventually lead to harm to

the patient. Because of these risks, it is the responsibility of all involved in scientific publishing

to make sure that only valid and unbiased research is conducted in a professional and competent

manner (Simundic, 2013). A third recommendation for future research is with longer lifestyle

interventions. In most of the studies, the lifestyle intervention was implemented in a six-month

period with one year follow-up (Sanghani et al., 2013). As a last recommendation, we encourage

researchers on further studies to find a relationship between glycemic control and risk factors

that worsen the course of type 2 diabetes. More studies are needed to test the effectiveness of

lifestyle interventions with patients that have had type 2 diabetes for a longer period and have

poor adherence to treatment (Kim et al., 2013).

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References

Abera, R. G., Demesse, E. S., & Boko, W. D. (2022). Evaluation of glycemic control and related

factors among outpatients with type 2 diabetes at Tikur Anbessa Specialized Hospital,

Addis Ababa, Ethiopia: A cross-sectional study. BMC Endocrine Disorders, 22(1), 1–11.

https://doi.org/10.1186/s12902-022-00974-z

Afroz, A., Ali, L., Karim, M. N., Alramadan, M. J., Alam, K., Magilano, D. J., & Billah, B.

(2019). Glycaemic control for people with type 2 diabetes mellitus in Bangladesh: An

urgent need for optimization of management plan. Scientfic Reports, 9(1), Article 10248.

https://doi.org/10.1038/s41598-019-46766-9

Avedzi, H. M., Mathe, N., Bearman, S., Storey, K., Johnson, J. A., & Johnson, S. T. (2017).

Examining diet-related care practices among adults with type 2 diabetes: A focus on

glycemic index choices. Canadian Journal of Dietetic Practice and Research, 78(1),

26–31. https://doi.org/10.3148/cjdpr-2016-021

Cash, J. & Glass, C. (2019). Adult-Gerontology Practice Guidelines. Springer Learning.

Dave, R., Davis, R., & Davies, J. (2019). The impact of multiple lifestyle interventions on

remission of type 2 diabetes mellitus within a clinical setting. Obesity Medicine, 13(1),

59-64. https://doi:10.1016/J.OBMED.2019.01.005

Dixit, J., Badgujar, S., & Giri, P. (2022). Reduction in HbA1c through lifestyle modification in

newly diagnosed type 2 diabetes mellitus patient: A great feat. Journal of Family

Medicine & Primary Care, 11(6), 3312–3317.

https://doi.org/10.4103/jfmpc.jfmpc_1677_21

Esposito, K., Maiorino, M. I., Ciotola, M., Di Palo, C., Scognamiglio, P., Gicchino, M., Petrizzo,

M., Saccomanno, F., Beneduce, F., Ceriello, A., & Giugliano, D. (2009). Effects of a
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Mediterranean-style diet on the need for antihyperglycemic drug therapy in patients with

newly diagnosed type 2 diabetes: A randomized trial. Annuals of Internal Medicine,

151(5), 306–314. https://doi.org/10.7326/0003-4819-151-5-200909010-00004

Faber, J., & Fonseca, L. M. (2014). How sample size influences research outcomes. Dental

Press Journal of Orthodontics, 19(4), 27–29.

http://dx.doi.org/10.1590/2176-9451.19.4.027-029.ebo

Johansen, M. Y., MacDonald, C. S., Hansen, K. B., Karstoft, K., Christensen, R., Pedersen, M.,

Hansen, L. S., Zacho, M., Wedell-Neergaard, A. S., Nielsen, S. T., Lepsen, U. W.,

Langberg, H., Vaag, A. A., Pedersen, B. K., & Ried-Larsen, M. (2017). Effect of

an intensive lifestyle intervention on glycemic control in patients with type 2 diabetes: A

randomized clinical trial. Journal of the American Medical Association, 318(7), 637–646.

https://doi.org/10.1001/jama.2017.10169

Kim, H. J., Jung, T. S., Jung, J. H., Kim, S. K., Lee, S. M., Kim, K. Y., Hahm, J. R., Kim, D. R.,

& Seo, Y. M. (2013). Improvement of glycemic control after re-emphasis of lifestyle

modification in type 2 diabetic patients reluctant to additional medication. Yonsei

Medical Journal, 54(2), 345-351. https://doi.org/10.3349/ymj.2013.54.2.345

Lynch, E. B., Mack, L., Avery, E., Wang, Y., Dawar, R., Richardson, D., Keim, K., Ventrelle, J.,

Appelhans, B. M., Tahsin, B., & Fogelfeld, L. (2019). Randomized trial of a lifestyle

intervention for urban low-income African Americans with type 2 diabetes.

Journal of General Internal Medicine, 34(7), 1174–1183.

https://doi.org/10.1007/s11606-019-04894-y

Martos-Cabrera, M. B., Gómez-Urquiza, J. L., Cañadas-González, G., Romero-Bejar, J. L.,

Suleiman-Martos, N., Cañadas-De la Fuente, G. A., & Albendín-García, L. (2021).

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Nursing-intense health education intervention for persons with type 2 diabetes: A quasi-

experimental Study. Healthcare (Basel), 9(7), 832-835.

https://doi:10.3390/healthcare9070832

Pot, G. K., Battjes-Fries, M. C., Patijn, O. N., Pijl, H., Witkamp, R. F., de Visser, M., van der

Zijl, N., de Vries, M., & Voshol, P. J. (2019). Nutrition and lifestyle intervention in type

2 diabetes: Pilot study in the Netherlands showing improved glucose control and

reduction in glucose lowering medication. BMJ Nutrition, Prevention & Health,

2(1), 43– 50. https://doi.org/10.1136/bmjnph-2018-000012

Rajput, S. A., Ashraff, S., & Siddiqui, M. (2022). Diet and management of type II diabetes in the

United Kingdom: A narrative review. Diabetology, 3(1), 72-78.

https://doi.org/10.3390/diabetology3010006

Sampson, M., Clark, A., Bachmann, M., Garner, N., Irvine, L., Howe, A., Greaves, C.,

Auckland, S., Smith, J., Turner, J., Rea, D., Rayman, G., Dhatariya, K., John, W. G.,

Barton, G., Usher, R., Ferns, C., & Pascale, M. (2021). Effects of the Norfolk diabetes

prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2

diabetes: A randomised controlled trial. BMC Medicine, 19(1), 183-203.

https://doi.org/10.1186/s12916-021-02053-x

Sanghani, N. B., Parchwani, D. N., Palandurkar, K. M., Shah, A. M., & Dhanani, J. V. (2013).

Impact of lifestyle modification on glycemic control in patients with type 2 diabetes

mellitus. Indian Journal of Endocrinology & Metabolism, 17(6), 1030–1039.

https://doi.org/10.4103/2230-8210.122618

Simundić, A. M. (2013). Bias in research. Biochemia Medica, 23(1), 12–15.

https://doi.org/10.11613/bm.2013.003
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Suntornlohanakul, O., Areevut, C., Saetung, S., Ingsathit, A., & Rattarasarn, C. (2020).

Glycemic effect of post-meal walking compared to one prandial insulin injection

in type 2 diabetic patients treated with basal insulin: A randomized controlled cross-over

study. PLoS ONE, 15(4), 1–9. https://doi.org/10.1371/journal.pone.0230554

Tappen, R. M. (2016). Advanced nursing research: From theory to practice. Jones & Bartlett

Learning.
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Appendix
Table of Findings
Article Citation Abera, R. G., Demesse, E. S., & Boko, W. D. (2022). Evaluation of
glycemic control and related factors among outpatients with type 2
diabetes at Tikur Anbessa Specialized Hospital, Addis Ababa,
Ethiopia: A cross-sectional study. BMC Endocrine Disorders, 22(1),
1–11. https://doi.org/10.1186/s12902-022-00974-z
Purpose/Hypothesis “The purpose of the study was to evaluate the level and factors
associated with glycemic control among type 2 diabetic outpatients
at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.”
(Abera et al., 2022).
Conceptual/Theoretical Neither a conceptual nor theoretical framework was used in this
Framework study.
Sample/Setting The sampling was done via a systematic random sampling technique
in which every fifth participant was selected and consent obtained
until the sample size of 325 patients was achieved (Abera et al.,
2022). The study sample consisted of patients with type 2 diabetes
mellitus who attended the clinic at the Tikur Anbessa specialized
hospital in Ethiopia for at least a year. It excluded persons who were
anemic, had received a blood transfusion and erythropoietin as well
as those who had conditions affecting erythrocyte production (Abera
et al., 2022). The sample size was obtained using a single population
proportion formula considering a 59.4% proportion of poor glycemic
control as reported in an earlier study with a confidence level of 95%
and 5% marginal error.
Variables Studied The dependent variable studied was the level of glycemic control
measured by HbA1c test and the independent variables included
sociodemographic factors of age, sex, marital status, educational
level, occupation, monthly income, residence, and access to
healthcare (Abera et al., 2022). Behavioral factors of adherence to
medications and diet, smoking, physical exercise, smoking, self-
monitoring of blood glucose, keeping up with follow-up visits, and
setting glycemic target goals as well as clinical factors. Clinical
factors included duration of diabetes, mode of therapy, BMI, family
history of diabetes, presence of comorbidity and biochemical value
(Abera et al., 2022).
Study Design/Level of Cross-sectional study, quantitative research level VI.
Research/Evidence
Threats to Internal and Internal validity is threatened because the sample size was smaller
External Validity and lacked generalizability (Abera et al., 2022). The study was
geared towards participants from one specific hospital system which
threatens external validity.
Measurements Measurements used were face to face interviews including structured
and pretested questionnaires (Abera et al., 2022). Laboratory
investigations such as HbA1c, fasting blood glucose, renal function
test and lipid profiles were also used.
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Data Analysis The statistical package for the social sciences version 26 was used
for data entry and analysis. Baseline demographic data from patients
was summarized using descriptive statistics which includes
frequency, percentages, and medians (Abera et al., 2022).
Association between predictors and outcome variables was assessed
using logistic regression analysis and factors with a P-value less than
0.25 in the bivariate analysis were exported to the multivariate
analysis (Abera et al., 2022). The multivariate analysis along with
logistic regression was used to assess independent predictors of
inadequate and poor glycemic control as well as controlling the
effect of potential cofounder variables. Associations that were
statistically significant were found based on the adjusted odds ratio
with its 95% confidence interval and the p-value less than 0.05%
(Abera et al., 2022). HBA1C target of less than 7% was considered
good control, 7-8 % inadequate control and greater than 8% poor
control (Abera et al., 2019).
Findings/Results The findings of the study showed that there were many diabetic
patients with inadequate and poor glycemic control levels which
amounted to 73.8% of the study participants and this was associated
with older age, insulin therapy, poor diet compliance, longer duration
of diabetes mellitus and failure to set control goals (Abera et al.,
2022). Noticeably, older patients 55 years and older had poorer
glycemic control than younger diabetic persons and persons who did
not adhere to the diet recommendations were twice as likely to have
poorer glycemic control (Abera et al., 2022).

If Replication is Replication is possible with a larger sample size to ensure greater

Possible representation and assessing the association between glycemic
control with varied factors that affect it over time (Abera et al.,
2022).

Article Citation Afroz, A., Ali, L., Karim, M.N., Alramadan, M. J., Alam, K.,
Magliano, D. J., & Billah, B. (2019). Glycaemic control for people
with type 2 diabetes mellitus in Bangladesh: An urgent need for
optimization of management plan. Scientific Reports, 9(1), Article
10248. https://doi.org/10.1038/s41598-019-46766-9
Purpose/Hypothesis "The objective of this study was to identify the determinants of
glycaemic control among people with type 2 diabetes mellitus in
Bangladesh.” (Afroz et al., 2019).
Conceptual/Theoretical Neither a conceptual nor theoretical concept was mentioned in the
Framework article.
Sample/Setting A confidence interval of 95% and 5% significance level with a 2.5%
margin level calculated a 935-sample size using a prior Bangladeshi
study (Afroz et al., 2019). The sample used for the study was a larger
size of 1253 patients 18 years and older with type 2 DM diagnosed
with diabetes for a year or longer with exclusion of other types of
diabetes. Of note, 53.2% of the study participants were male, the
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mean age was 54.2 years and mean duration of diabetes was 9.9
years (Afroz et al., 2019).
Variables Studied The variables studied were glycemic control, low educational level,
unhealthy habits, use of insulin, oral hypoglycemic agents,
infrequent follow ups, healthy lifestyle interventions and a history of
coronary artery disease (Afroz et al., 2019).
Study Design/Level of A cross-sectional survey, level of evidence is level VI was employed
Research/Evidence for this study.
Threats to Internal and Some of the questionnaires were changed which threatened internal
External Validity validity because the researchers chose which parts of the
questionnaires to exclude which increases bias (Afroz et al., 2019).
Even though the hospital system used was the largest care provider
in Bangladesh, external validity was threatened because the
participants was specifically selected from those hospitals associated
with the Diabetic Association of Bangladesh. Of note, the
researchers ensured that the hospitals where the participants were
selected had participants from the rural, urban and semi-urban areas
to promote an inclusive and heterogeneous sample (Afroz et al.,
2019).
Measurements A pretested questionnaire through a pilot survey in the Bangladesh
Institute of Health Sciences Hospital was used during a face-to-face
interview with the participants (Afroz et al., 2019). A data extraction
checklist was used to retrieve data from patient’s records such as
laboratory tests, diagnosis, comorbidities, complications history and
medications. The UK Diabetes and diet questionnaire was adjusted
to fit the Bangladeshi population and six selected items from the
Global Physical Activity Questionnaire was used to assess physical
activity levels (Afroz et al., 2019). Generalized Anxiety Disorder
Scale, Michigan Neuropathy Screening Instrument and six item
cognitive impairment test were also used. The height and weight of
participants were measured as well as waist and hip circumference,
BMI, and waist-hip ratio (Afroz et al., 2019).
Data Analysis ANOVA, chi-square tests, simple logistic regression analysis were
used for univariate analysis were used to measure the relationship
between risk factors and glycemic level controls (Afroz et al., 2019).
All risk factors with a p-factor less than 0.05 in simple logistic
regression analysis were examined for a multiple logistic regression
model. However, the multiple logistic regression model was mostly
used to assess the determinants for inadequate and poor glycemic
control (Afroz et al., 2019). Duration-specific risk factors were
assessed through stratification into two distinct categories: greater
than and less than five years. Data analysis was conducted by using
the statistical software package STATA SE version 15 (Afroz et al.,
2019).
Findings/Results 82% of the study participants had inadequate glycemic control and
54.7% had extremely poor control which is defined as HbA1C equal
to or greater than 9% (Afroz et al., 2019). This study showed that
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there are many determinants for poor and inadequate glycemic

control. The type of treatment affected glycemic control and the
participants who were on oral antidiabetic medication had the best
glycemic control (Afroz et al., 2019). The study also interestingly
showed that there was an association between cognitive function
impairment and poor glycemic control in patients who were
diagnosed with diabetes for a longer period. A healthy lifestyle was
found to improve and support good glycemic control (Afroz et al.,
2019). The study also showed that women who were diagnosed with
diabetes type 2 for a longer period had the poorest glycemic control.
If Replication is Replication of the study is possible with a different population which
Possible could be diabetic patients outside of the hospitals affiliated with the
Diabetic Association of Bangladesh at multiple sites to increase
validity and rigor (Afroz et al., 2019). The study could also be
replicated in other countries.

Article Citation Dave, R., Davis, R., & Davies, J. (2019). The impact of multiple
lifestyle interventions on remission of type 2 diabetes mellitus within
a clinical setting. Obesity Medicine, 13(1), 59-64.
https://doi:10.1016/J.OBMED.2019.01.005
Purpose/Hypothesis “To evaluate the impact of numerous lifestyle modifications in type
2 diabetes.”
Conceptual/Theoretical Look AHEAD study.
Framework
Sample/Setting A group of obese and overweight participants over the age of 18 with
diagnosed type 2 diabetes were recognized from the clinic register of
a private endocrinology practice in Mumbai, India (Dave et al.,
2019). After the interview, 45 participants with type 2 diabetes were
signed up to a lifestyle intervention program.
Variables Studied The independent variable is lifestyle interventions on patients with
type 2 diabetes while the dependent variable was weight,
hemoglobin A1c, remission of type 2 diabetes, pharmacological
therapy, costs, compliance, and baseline characteristics.
Study Design/Level of Survey research, Randomized, Level VI
Research/Evidence
Threats to Internal and In terms of internal validity, small sample size from a particular
External Validity office, which introduces a selection bias which can therefore limit
the applicability of this approach in a wider clinical setting (Dave et
al., 2019). A threat to external validity is that researchers only
studied the impact of hypertension and hyperlipidemia on diabetes
lacking other cardiovascular risk factors which decreases
generalizability.
Measurements Measurements include demographic characteristics, hemoglobin
A1c, weight, lipids, self-monitoring of blood glucose (SMBG), ECG,
diet recall, physical activity recall, height, weight, BMI, and medical
or social history. For diabetes, the age of onset, duration, and age of
18

intervention was measured. These were collected at the beginning of

the study and one-to-five-year post lifestyle intervention
implementation.
Data Analysis Exams were completed using SPSS software. Data is showed as
frequency or mean + SD, independent sample T test was used to
compare difference in parameters between males and females (Dave,
et al., 2019). Paired sample T test was used to analyze the difference
in parameters between onset, year one and year five. Cross
tabulations were computed and analyzed using a chi-square test to
study associations and P value less than 0.05 was thought to be
statistically notable (Dave, et al., 2019).
Findings/Results The study proved that lifestyle intervention can lead to remission of
type 2 diabetes up to 5 years after intervention by showing weight
loss, and improved glycemic control (Dave et al., 2019). Costs of
medications were lowered by declining the use of pharmacological
interventions. Over five years, diabetes remission persisted in most
participants besides modest weight regain (Dave et al., 2019).
If Replication is Replication of this study would be possible using a larger sample
Possible size. Also using patients from more than 1 office would help
decrease the selection bias.

Article Citation Dixit, J., Badgujar, S., & Giri, P. (2022). Reduction in HbA1c
through lifestyle modification in newly diagnosed type 2 diabetes
mellitus patient: A great feat. Journal of Family Medicine &
Primary Care, 11(6), 3312–3317.
https://doi.org/10.4103/jfmpc.jfmpc_1677_21
Purpose/Hypothesis This study’s purpose is to prove that lifestyle modifications are a
better choice compared to pharmacological therapy including
antidiabetic medications and insulin therapy in patients with type 2
diabetes (Dixit et al., 2022). The hypothesis of this study is by
implementing a 2-OMEX-plan into action, “meal frequency
limitation will limit the insulin spikes and thus reduce the cause for
insulin resistance and ultimately reduction in the resulting incidence
of obesity”.
Conceptual/Theoretical None.
Framework
Sample/Setting A 45-year-old male diagnosed with type 2 diabetes. On diagnosis,
HbA1c 14.9%. Lives a sedentary lifestyle, works from home, and
does not exercise (Dixi et al., 2022).
Variables Studied Examine lifestyle interventions and their effect on type 2 diabetes.
The exercise routine consisted of walking a minimum of 4.5 km in
45 minutes daily. The dietary regimen consisted of eating two meals
per day.
Study Design/Level of Single descriptive/qualitative/physiological study, level VI.
Research/Evidence
Threats to Internal and This study follows the data on only one patient, causing concern for
19

External Validity the internal validity of the study (Dixit et al., 2022). This does not
provide a large enough sample size to assess the validity of the
interventions that were implicated, thus skewing results in terms of
external validity.
Measurements This study measured HbA1c and weight monthly, and blood sugars
before and after each meal. Patient’s waist circumference, blood
pressure, and fasting insulin level were recorded at each visit.
Data Analysis Two-line graphs depicting HbA1c and fasting blood glucose values
over the course of 5 months were compared. The weight of the
patient after the Dixit diet was analyzed using a table comparison
(Dixit et al., 2022).
Findings/Results The study was effective as evidenced by the success of HbA1c being
reduced by 9.8% in three months with no medications (Dixit et al.,
2022). Lifestyle interventions are easy and safe to implement to
improve blood glucose and glycemic control in comparison to
pharmacological therapy. With education and counseling, patients
will be more likely to adhere to lifestyle interventions than treatment
with antihyperglycemic medications (Dixit et al., 2022). Reversal of
type 2 diabetes can be achieved by implementing lifestyle
interventions including diet and exercise as evidenced by improved
HbA1c.
If Replication is Replication of this study would be possible and would increase the
Possible validity of the data with usage of a larger sample size.

Article Citation Esposito, K., Maiorino, M. I., Ciotola, M., Di Palo, C.,
Scognamiglio, P., Gicchino, M., Petrizzo, M., Saccomanno, F.,
Beneduce, F., Ceriello, A., & Giugliano, D. (2009). Effects of a
Mediterranean-style diet on the need for antihyperglycemic drug
therapy in patients with newly diagnosed type 2 diabetes: A
randomized trial. Annuals of Internal Medicine, 151(5), 306–314.
https://doi.org/10.7326/0003-4819-151-5-200909010-00004
Purpose/Hypothesis “To compare the effects of a low-carbohydrate Mediterranean-style
or a low-fat diet on the need for antidiabetic drug therapy in patients
with newly diagnosed type 2 diabetes.” (Esposito et al., 2009).
Conceptual/Theoretical None.
Framework
Sample/Setting 215 people of any gender were overweight and newly diagnosed
with type 2 diabetes who lived a sedentary lifestyle (Esposito et al.,
2009). Inclusion criteria included BMI greater than 25 kg,
hemoglobin A1c less than 11%, and age between 30 to 75 years.
Trial was completed in January 2004 to September 2008 in a
research center in the Diabetes Clinic in Naples, Italy (Esposito et
al., 2009).
Variables Studied Glycemic control of patients with type 2 diabetes who took part in a
low-carbohydrate Mediterranean diet versus low-fat diet (Esposito
et al., 2009). The outcome that was studied was the start of
20

antihyperglycemic drug therapy and changes of weight.

Study Design/Level of Single-center, randomized trial, quantitative research. level II.
Research/Evidence

Threats to Internal and Dietary intake was self-reported which can have bias in terms of
External Validity internal validity (Esposito et al., 2009). Also, the researchers for
starting antihyperglycemic drug therapy were not blinded and
participants were knowledgeable about the study. For external
validity, generalizability of the results may be difficult to assess as
patients were highly educated about the importance of diet (Esposito
et al., 2009).
Measurements Measurements that were studied included BMI, waist
circumference, and hemoglobin A1c levels at the beginning and 3
months after intervention. Participants were educated to keep food
diaries to record their intake using food models (Esposito et al.,
2009).
Data Analysis Researchers compared risk factors and dietary intake using values at
the end of the follow-up and a t test based on differences (Esposito
et al., 2009). The Fisher exact test was used to assess patients’ goals
and calculated the Kaplan-Meier survival curves for
antihyperglycemic drug therapy with a 2-sided log-rank test. Cox
regression was performed to time weight loss and
antihyperglycemic drug therapy (Esposito et al., 2009). Statistical
measurements were 2-sided with results shown as means and
standard deviations.
Findings/Results When compared to a low- fat diet, the Mediterranean-style diet led
to more favorable changes in glycemic control and reduction of
coronary risk factors. These results also delayed the need for
antihyperglycemic agents (Esposito et al., 2009). There was a
significant difference in the Mediterranean diet group with a
decrease in plasma glucose and hemoglobin A1c levels as well as
greater insulin sensitivity.
If Replication is Replication of this study with a larger sample size would be possible
Possible and should be done by dropping the self-reporting of dietary intake.

Article Citation Johansen, M. Y., MacDonald, C. S., Hansen, K. B., Karstoft, K.,
Christensen, R., Pedersen, M., Hansen, L. S., Zacho, M., Wedell-
Neergaard, A. S., Nielsen, S. T., Lepsen, U. W., Langberg, H., Vaag,
A. A., Pedersen, B. K., & Ried-Larsen, M. (2017). Effect of an
intensive lifestyle intervention on glycemic control in patients with
type 2 diabetes: A randomized clinical trial. Journal of the American
Medical Association, 318(7), 637–646.
https://doi.org/10.1001/jama.2017.10169
Purpose/Hypothesis “An intensive lifestyle intervention is equivalent compared with
21

standard care in maintaining glycemic control in participants with

type 2 diabetes diagnosed less than 10 years, and secondarily leads to
a reduction in glucose-lowering medication” (Johansen et al., 2017).
Conceptual/Theoretical Based on the Action for Health in Diabetes (Look AHEAD) study
Framework (Johansen et al., 2017).
Sample/Setting Participants were recruited using social media and the Danish
Diabetes Association through the telephone and physical
examinations (Johansen et al., 2017). Inclusion criteria included
participants with type 2 diabetes diagnosed less than 10 years, BMI
between 25-40 and taking 2 or less antidiabetic medications.
Exclusion criteria was A1C greater than 9%, insulin dependence, or
diabetes complications (Johansen et al., 2017). The sample size was
98 participants that fit the criteria in Region Zealand and the Capital
Region of Denmark. 64 participants were randomly placed in the
lifestyle group and the remaining 34 were in the control, or standard
care group (Johansen et al., 2017).
Variables Studied Type 2 diabetic patients in an intensive lifestyle intervention group of
supervised exercise training and standard care group including
education, counseling, and lifestyle advice.
The outcomes were stated in the research study.
1. Change in HbA1C from baseline to 12-month follow-up.
2. Reduction in glucose-lowering medication from baseline to
12-month follow-up.
Design/Level of Single-center, assessor-blinded, randomized trial, quantitative
Research/Evidence research. level II.

Threats to Internal and Threats to internal validity are from the self-reported dietary intake
External Validity which can have bias (Johansen et al., 2017). There are several
lifestyle elements used in this article which can hinder the analysis of
each specific part. Threats to the external validity are from the
inclusion criteria which may limit generalizability based on the
results of the Look AHEAD study (Johansen et al., 2017). It is not
possible to generalize the results to other combinations of antidiabetic
medications as only limited drugs were used in this study.
Measurements Measurements included total cholesterol, LDL, HDL, triglycerides,
blood pressure, fasting insulin, fasting glucose, 2-hour glucose with
OGTT, maximal oxygen uptake, BMI, fast mass, and lean body mass
before and after intervention (Johansen et al., 2017). Also, change in
hemoglobin A1c from baseline was measured. Exercise sessions were
encouraged which were monitored using smartwatch devices to
measure the number of steps taken and exercise interventions
(Johansen et al., 2017). There were self-reported dietary intake forms
that were filled out for each participant.
Data Analysis Data analysis for the first outcome was performed with the intention-
to-treat principle in mind to measure equivalence using two 1-sided
test analysis and 2-sample normal means (Johansen et al., 2017). P-
values and estimates of the change were measured. Superiority
22

analysis was performed on the secondary outcomes for the glucose-

lowering medications (Johansen et al., 2017). In terms of the group
that had changes to their antidiabetic medications, the follow up was
test using a X 2 and Wilcoxon rank-sum tests. For the sensitivity
analyses, it included specific techniques such as baseline-observation
carried forward imputation technique, complete-case and multiple
linear imputation Lifestyle Improvement through Food and Exercise
(LIFE) intervention compared to diabetes self-management education
(DSME) analyses (Johansen et al., 2017). To complete the statistical
analysis, it was performed using STATA/IC, version 13.1.
Findings/Results  There was a hemoglobin A1c difference of 6.65% to 6.34% in
the lifestyle group where in other group that primarily was on
pharmacological therapy, the A1C changed from 6.74% to
6.66% (Johansen et al., 2017). These results did not meet the
criteria for equivalence.
 In the lifestyle group, participants were more likely to stop
taking pharmacological therapy due to improved glycemic
control in comparison to the control group.
 The article found that an intensive lifestyle intervention (diet
and exercise) was nonequivalent compared with
pharmacological treatment in supporting glycemic control
(Johansen et al., 2017).
 Using the lifestyle intervention, participants were able to stop
taking glucose-lowering medications. Although lifestyle
intervention did not meet the criteria for glycemic control,
there was a potential benefit as it was trending downward.
 “Greater improvement in glycemic control is associated with
higher levels of physical activity, beyond the current physical
activity recommendations for patients with type 2 diabetes”
(Johansen et al., 2017, p. 644).
If Replication is Replication is possible by using more diabetic medications and
Possible maximizing the inclusion criteria for participants. A larger sample
size will also help with replication. Further research is needed to
generalize the findings and assess superiority.

Article Citation Kim, H. J., Jung, T. S., Jung, J. H., Kim, S. K., Lee, S. M., Kim, K.
Y., Hahm, J. R., Kim, D. R., & Seo, Y. M. (2013). Improvement of
glycemic control after re-emphasis of lifestyle modification in type 2
diabetic patients reluctant to additional medication. Yonsei Medical
Journal, 54(2), 345-351. https://doi.org/10.3349/ymj.2013.54.2.345
Purpose/Hypothesis “The purpose of this study is to discover glycemic changes after
stressing the importance of lifestyle modification in patients with
mild to moderate uncontrolled type 2 diabetes.”
Conceptual/Theoretical None.
Framework
Sample/Setting 51 participants were selected from the outpatient endocrinology
23

department at Gyeonsang National University Hospital in Oct 2010

to January 2021 (Kim et al., 2013). All the participants did not want
added drug therapy with HbA1c levels ranging between 7-9% with
first use of oral antihyperglycemic medications
Variables Studied The dependent variable is the glycemic control of patients with type
2 diabetes while the dependent variable is re-education of lifestyle
interventions to patients with uncontrolled diabetes who are not
reluctant to taking more antihyperglycemic medications (Kim et al.,
2013).
Study Design/Level of Survey research, quantitative research study. level IV of evidence.
Evidence
Threats to Internal and In terms of internal validity, HbA1c levels were only measured after
External Validity re-education about lifestyle modifications (Kim et al., 2013). Threats
to external validity were that there was a small sample size, and the
research study was completed in a brief time which cannot be
generalized to the entire population of type 2 diabetics.
Measurements Age, gender, duration of diabetes, drinking, smoking, education,
occupation, family history of diabetes, HbA1c, height, weight, daily
diet and exercise were analyzed. Researchers used daily surveys
with one question about diet and the other about exercise with
selected responses (Kim et al., 2013). Other measurements that were
examined included plasma glucose level, C-peptide, fasting insulin,
total cholesterol, HDL, LDL, triglycerides, serum creatinine, and
albumin to creatinine ratio. GFR was calculated using Cockcroft-
Gault equation (Kim et al., 2013).
Data Analysis All data were statistically examined by PASW software. Data in the
figures are mean or standard deviation values (Kim et al., 2013).
Differences between the 2 groups were evaluated by a non-
parametric Mann-Whitney U test while the difference between
individual variables was checked by the Pearson chi-square test
using the coefficient p<0.05 (Kim et al., 2013).
Findings/Results  18 out of the total 51 participants showed decreased HbA1c
levels after 3 months, and HbA1c values of 11 patients were
less than 7% (Kim et al., 2013).
 Participants who followed lifestyle modification of diet and
exercise had a notably lessened HbA1c level compared with
the HbA1c level of patients who declined lifestyle change.
 Re-education about lifestyle interventions can improve
compliance for patients with type 2 diabetes (Kim et al.,
2013).
If Replication is Replication is possible with a larger sample size and longer follow-
Possible up studies.

Article Citation Lynch, E. B., Mack, L., Avery, E., Wang, Y., Dawar, R.,
Richardson, D., Keim, K., Ventrelle, J., Appelhans, B. M., Tahsin,
B., & Fogelfeld, L. (2019). Randomized trial of a lifestyle
24

intervention for urban low-income African Americans with type 2

diabetes. Journal of General Internal Medicine, 34(7), 1174–1183.
https://doi.org/10.1007/s11606-019-04894-y
Purpose/Hypothesis “Examine whether the LIFE intervention resulted in greater long-
term improvements in glycemic control than a comparison
intervention consisting of two group classes taught by a registered
dietitian (RD). We hypothesized that intervention participants would
show a greater A1c reduction at 12 months than comparison
participants and that the difference would be sustained 6 months
after the conclusion of the intervention (at 18 months)” (Lynch et al.,
2019)
Conceptual/Theoretical None.
Framework
Sample/Setting 6 groups of 30-40 people from five outpatient primary care clinics
that were from the Cook County Health and Hospitals system in
Illinois (Lynch et al., 2019). A total of 211 eligible participants were
randomly grouped into intervention vs control groups. Recruitment
occurred between March 2013 to April 2014 while the intervention
group occurred between August 2012 to August 2015 (Lynch et al.,
2019). Inclusion criteria included uncontrolled type 2 diabetes with
HbA1c greater than 8%, African American, older than 18 years old,
seen at least once at the clinic, and available to attend group sessions.
Variables Studied Variables that were studied included patient demographic
information, glycemic control, BP, BMI, medications, medical
history, diet, alternative healthy eating index, physical activity,
nutrition knowledge, medication adherence, depression, perceived
social support, diabetes-specific quality of life, self-efficacy, and
health literacy (Lynch et al., 2019). The LIFE intervention was used
which included these variables in patients with type 2 diabetes to
assess the effectiveness.
Study Design/Level of Single-center, randomized trial, clustering study design. level II.
Research/Evidence
Threats to Internal and Threats to internal validity include that diet and physical activity
External Validity were not measured at 6 months which does not prove that they led to
HbA1c changes (Lynch et al., 2019). Dietary changes were self-
reported which can be biased, and dietary recalls were limited. There
was a limited sample size which can be a threat to external validity.
Measurements Measures included self-reported demographic questionnaires,
hemoglobin A1c levels, blood pressure (average of three readings),
weight, self-reported medical history, dietary intake using 24-hour
dietary recall, mean weekly exercises measured with the ACTi graph
GT3X, Nutrition Knowledge Questionnaire, AdultCarbQuiz, and
PHQ-9. Other items that were included from the Diabetes Care
Profile are support received, social/personal factors, and self-care
profile. Lastly, the newest vital sign (NVS) was conducted.
Data Analysis Descriptive analyses were measured using mean and standard
deviations (Lynch et al., 2019). Frequencies, percentages, and other
25

quartiles were used for categorical or non-normal data. ANCOVA

was used to measure the differences in patient characteristics (Lynch
et al., 2019). A cluster-adjusted chi-square test and Fishers exact test
were used in the categorical data. For analyzing HbA1C, cluster
adjusted ANVOVA modeling was used. Also, mixed effects
modeling with unstructured variances tested trends (Lynch et al.,
2019). Other data analysis used included priori specified covariates,
and three-way interaction term. All the statistical tests were two-
sided using SAS software (Lynch et al., 2019).
Findings/Results  The LIFE interventions resulted in an increased knowledge of
nutrition and diet quality while the DSME interventions
resulted in increased medication adherence (Lynch et al.,
2019).
 Participants who used the intervention had significantly
improved A1c reductions at 6 months that kept for at least a
year or more.
 Diet can be especially important in glycemic control as it can
improve other health measures (Lynch et al., 2019).
 Lifestyle interventions can be difficult for patients in
minority groups due to lack of safe areas to exercise, food
insecurity, stress, and violence.
 Patients who used the LIFE intervention had improve
glycemic control (Lynch et al., 2019).
If Replication is Replication of this study is possible with a larger sample size to
Possible reduce the threat of external validity.

Article Citation Pot, G. K., Battjes-Fries, M. C., Patijn, O. N., Pijl, H., Witkamp, R.
F., de Visser, M., van der Zijl, N., de Vries, M., & Voshol, P. J.
(2019). Nutrition and lifestyle intervention in type 2 diabetes: Pilot
study in the Netherlands showing improved glucose control and
reduction in glucose lowering medication. BMJ Nutrition,
Prevention & Health, 2(1), 43–50. https://doi.org/10.1136/bmjnph-
2018-000012
Purpose/Hypothesis “The hypothesis was that patients with type 2 diabetes would
significantly reduce their HbA1C levels and use of glucose lowering
medication in response to a 6-month multi-component
multidisciplinary program including intensive counseling on
nutrition and lifestyle, digital coaching/educational program,
physician guided medication management and cooking classes” (Pot
et al., 2019).
Conceptual/Theoretical Theory is not applicable but focuses on nutrition and lifestyle. The
Framework program is Reverse Diabetes 2 which is developed by the Foundation
Nutrition Alive (Pot et al., 2019).
Sample/Setting Participants completed the program between February 2015 to
March 2016 using a stepped-wedge design (Pot et al., 2019).
Inclusion criteria was diagnosis of type 2 diabetes, age 18-75, BMI
26

25-41, ability to speak Dutch fluently, and motivation to complete

the program. 72 patients completed the baseline and follow-up
questionnaire (Pot et al., 2019).
Variables Studied Type 2 diabetic patients, lifestyle interventions, hemoglobin A1c
levels, medication use, and subjective quality of life from
participants.
1. HbA1C levels
2. Use of glucose lowering medications
3. Type 2 diabetic markers
Study Design/Level of Pretest posttest design, observational study. Level II.
Research/Evidence
Threats to Internal and The study did not include a control group and had a small sample
External Validity size which is a threat to external validity (Pot et al., 2019). In terms
of internal validity, selection bias may have interfered with this study
as participants joined with their own incentive and needed to
contribute financially to the program to increase intrinsic motivation.
Also, participants used self-reported answers which could have bias
(Pot et al., 2019).
Measurements Baseline and follow-up questionnaires on health, quality of life, type
2 diabetes parameters, and adherence to the program (Pot et al.,
2019). Measurements included self-reported blood lipid profile,
height, weight, waist circumference, program adherence and
appreciation, subjective health parameters, and physical activity
levels. Also, hemoglobin A1c levels were measures of the study (Pot
et al., 2019). Patients self-reported their medications as classification
between 0 to 3. 0 was no medication, 1 was only Metformin, 2 was
sulfonylureas/metformin, and 3 was insulin mixed with one
antidiabetic medication (Pot et al., 2019). Participants self-reported
their perceived health and quality of life using a 10-point Likert scale
and their fatigue during the intervention using the Checklist
Individual Strength (CIS) questionnaire. Sleep problems, program
adherence, and physical activity were assessed using a 5-point Likert
scale during each meal (Pot et al., 2019). Also, program adherence
was assessed using a 10-point Likert scale. Demographic
information was collected for each participant (Pot et al., 2019).
Data Analysis The statistical analysis was completed by using SPSS (Statistical
Package for the Social Sciences) (Version 23). The descriptive
analyses were performed by describing the demographic
characteristics of participants (Pot et al., 2019). Data was denoted as
mean standard deviation and paired sample t-tests after each
parameter. Stratified analyses were completed with hemoglobin
A1cs that were below or met the baseline (Pot et al., 2019).
Findings/Results  Results of the study showed that participants in the study that
completed the lifestyle intervention program had significantly
lower hemoglobin A1c levels 6 months after than at baseline
(Pot et al., 2019).
 Participants with higher hemoglobin A1c showed a greater
27

decrease in their level with the intervention which was 9

mmol lower than baseline.
 It also showed that participants had lowered glucose levels,
body weight, waist circumference, and BMI after using the
program (Pot et al., 2019).
 “The findings of this 6-month multicomponent group-based
nutrition and lifestyle intervention reflected lower HbA1C
levels and a reduction of antidiabetic medications in
motivated type 2 diabetes patients” (Pot et al., 2019).
 49% of the participants had to have their antidiabetic
medications stopped or reduced within 6 months of the
program (Pot et al., 2019).
If Replication is It is possible to replicate this study if a larger sample size is used and
Possible the development of an infrastructure is used for data collection or
analysis (Pot et al., 2019). Replication is possible to aid in evidence-
based practice.

Article Citation Sampson, M., Clark, A., Bachmann, M., Garner, N., Irvine, L.,
Howe, A., Greaves, C., Auckland, S., Smith, J., Turner, J., Rea, D.,
Rayman, G., Dhatariya, K., John, W. G., Barton, G., Usher, R.,
Ferns, C., & Pascale, M. (2021). Effects of the Norfolk diabetes
prevention lifestyle intervention (NDPS) on glycaemic control in
screen-detected type 2 diabetes: A randomised controlled trial. BMC
Medicine, 19(1), 183-203. https://doi.org/10.1186/s12916-021-
02053-x
Purpose/Hypothesis “The purpose of this trial was to test if the Norfolk Diabetes
Prevention Study (NDPS) lifestyle intervention improved glycemic
control in people with newly diagnosed screen-detected type 2
diabetes.”
Conceptual/Theoretical Neither a conceptual nor theoretical framework was mentioned in
Framework this article.
Sample/Setting Screening and randomization were done from August 2011 to June
4, 2017, were collected in 8 screening sites east of England. All the
screening sites were primary care offices that were eligible for
participation (Sampson et al., 2021). A dedicated algorithm in the
trial data management system was used to randomize participants
(Sampson et al., 2021). Participants were categorized into three
groups; control arm for those who received no trial intervention, the
intervention arm for persons who received lifestyle interventions and
an intervention arm (INT-DPM) for those who received the same
lifestyle interventions but had addition support via telephone from
peer volunteer diabetes prevention mentors. The sample size was 432
research participants (Sampson et al., 2021).
Variables Studied Dependent variable was the glycemic control and independent
variable was Norfolk lifestyle interventions (Sampson et al., 2021).
Study Design/Level of A parallel three-arm, randomized control trial, level II.
Research/Evidence
28

Threats to Internal and Threats to external validity are that most of the participants were
External Validity white which may not be generalized to the population of type 2
diabetes (Sampson et al., 2021). On the other hand, threats to internal
validity include subjective measures of diet and physical activity.
Measurements This included BMI, visceral fat, fasting plasma insulin, HbA1C,
weight, questionnaires for resistance and physical activity (Sampson
et al., 2021). Dietary intake of fat and fiber was examined with the
Diet Behaviour Questionnaire while quality of life measured with the
Audit of Diabetes-dependent Quality of life. Well-being was
assessed by the WBQ-12 questionnaire and health related quality of
life was measured with the EuroQol EQ-5D (Sampson et al., 2021).
Diabetes treatment was measured with the Diabetes Treatment
Satisfaction Questionnaire. Medication use was obtained using the
health resources use questionnaire, the trial report form and direct
interview (Sampson et al., 2021).
Data Analysis Data analysis was done using linear regression model with the arm
as a fixed effect and adjusted for the baseline value of the outcome
(Sampson et al., 2021). The analysis compared the mean HBA1C
among the three trial arms and logistic regression were used for
comparing binary outcomes. The study also used a post hoc analysis
for oral antidiabetics use or no oral antidiabetic use (Sampson et al.,
2021). Pre-specified subgroup analyses were through showing an
interaction between the arm and the subgroup in the regression
models separately for sex, age (< 65 vs ≥ 65), deprivation quartile,
and BMI quartile.
The study controlled for type 1 error by pre specifying a restricted
analysis to 12 and 24 month (about 2 years) follow up data with the
primary endpoint being 12 months (Sampson et al., 2021).
Findings/Results The NDPS lifestyle intervention greatly improved glycaemic control
in people with screen-detected type 2 diabetes when supported by
trained peer mentors with type 2 diabetes after 12 months, mostly in
those receiving oral hypoglycemics and those under 65 years old
(Sampson et al., 2021). The effect size was modest, however, and not
sustained at 24 months. It also revealed that NDPS offers a valuable
contribution to clinicians and policymakers because it is effective for
not only glycemic control in screen-detected type 2 diabetics but also
in preventing diabetes (Sampson et al., 2021). This trial shows that
diet and lifestyle interventions can reduce the risk of type 2 diabetes.
Most patients who have higher glycemic control have support
(Sampson et al., 2021).
If Replication is Replication is possible with a larger sample size for each group.
Possible

Article Citation Sanghani, N. B., Parchwani, D. N., Palandurkar, K. M., Shah, A. M.,
& Dhanani, J. V. (2013). Impact of lifestyle modification on
glycemic control in patients with type 2 diabetes mellitus. Indian
Journal of Endocrinology & Metabolism, 17(6), 1030–1039.
29

https://doi.org/10.4103/2230-8210.122618
Purpose/Hypothesis “To assess the effect of structured exercise training and unstructured
physical activity interventions on glycemic control in patients with
type 2 diabetes with little dietary changes.” (Sanghani et al., 2013).
Conceptual/ Neither a conceptual nor a theoretical framework was used to guide
Theoretical this study.
Framework
Sample/Setting 279 patients with type 2 diabetes took part in a six-month exercise
intervention between October 2011 to July 2012 (Sanghani et al.,
2013). Inclusion criteria included sedentary 30- to 60-year-old adults
of either sex with type 2 diabetes for more than a year with A1C
levels higher than 6.5%. The participants must have lived in or
around Ahmedabad (Gujara) and attended the diabetes clinic at B. J.
Medical College and Civil Hospital (Sanghani et al., 2013).
Variables Studied Type 2 diabetes patients using structured exercise training,
unstructured activity, and control groups.
The variables in the study were mentioned.
1. Change in HbA1C from baseline to end of intervention.
2. Measures of anthropometry, lipid levels, and blood pressure.
Study Design/Level of Randomized, six-month intervention study. Level II.
Research/Evidence
Threats to Internal and A threat to external validity is that sampling cannot be generalized to
External Validity the entire population as the participants were motivated, healthy, and
able to take part in this study (Sanghani et al., 2013). A threat to
internal validity is that the effect of medications was not considered
when this study was completed. Also, there was a lack of supervision
in the unstructured activity group which could mean there was less
reported physical activity (Sanghani et al., 2013).
Measurements The measures were weight, height, BMI, waist circumference, and
blood pressure (Sanghani et al., 2013). Venous sampling was
completed before and after intervention by measuring glucose,
cholesterol, triglycerides, HDL, LDL, and HbA1C.
Data Analysis All analyses were performed using SPSS software (SPSS, version
15.0). Two group comparisons were made using X2 or Fishers exact
tests for categorical variable while student’s t-tests or one way
ANOVA for continuous variables (Sanghani et al., 2013).
Findings/Results  It was found that supervised structured exercise training
involving aerobic and resistance exercises was more effective
than unstructured activity, or increase physical activity, in
reducing A1C levels (Sanghani et al., 2013).
 The researchers found that improvements from exercise in
glycemic control were greater for those with higher A1C
values.
 In patients with type 2 diabetes, exercise can reduce
hemoglobin A1c levels by 0.14%, but in structured programs,
it can drastically reduce this by 0.59% (Sanghani et al., 2013).
 There was substantial improvement in cardiovascular risk
30

factors when using structured training programs.

 Exercise can improve glycemic control in patients with type 2
diabetes based on the findings of this study (Sanghani et al.,
2013). It does not need to reduce body weight to have an
impact on glycemic control.
If Replication is Replication is possible with longer interventions with better
Possible understanding of body composition changes.

Article Citation Suntornlohanakul, O., Areevut, C., Saetung, S., Ingsathit, A., &
(C) Rattarasarn, C. (2020). Glycemic effect of post-meal walking
compared to one prandial insulin injection in type 2 diabetic patients
treated with basal insulin: A randomized controlled cross-over study.
PLoS ONE, 15(4), 1–9. https://doi.org/10.1371/journal.pone.0230554
Purpose/Hypothesis To compare the successfulness of post-meal walking with one
prandial insulin on glycemic control in type 2 diabetic patients where
basal insulin therapy is not effective.
Conceptual/ None.
Theoretical
Framework
Sample/Setting Patients aged 35-70years with type 2 diabetes who were treated with
at least one oral hypoglycemic drug and basal insulin (NPH,
Determir, Glargine, or Degludec) were drafted from an outpatient
clinic. Inclusion criteria included patients who had a fasting plasma
glucose less than 150mg/dl and HbA1c levels between 7-9%
(Suntornlohanakul et al., 2020). Exclusion criteria included patients
with uncontrolled hypertension, recent MI, ischemic stroke within 3
months, chronic lung diseases or heart failures, foot problems (severe
diabetic neuropathy, fracture, deformity, previous amputation) which
were an obstacle to walking, currently on systemic steroids, alcohol
consumption more than 7 drinks per week or caffeine consumption
more than 400mg/day, travel regularly across time zone or perform
shift work (Suntornlohanakul et al., 2020). 19 participants were
included in this study at an outpatient clinic at Ramathibodi hospital
in Bangkok, Thailand.
Variables Studied 1. Type 2 diabetic patients aged 35-70 years who were treated
with at least one oral hypoglycemic and basal insulin.
2. Post-meal walking and its effect on postprandial plasma
glucose
Study Design/Level of Randomized controlled, cross over study, Level V.
Research/Evidence
Threats to Internal and Threats to internal validity are from blood glucose monitoring data
External Validity that was only measured once weekly which is not a true
representation of daily blood sugars (Suntornlohanakul et al., 2020).
The length of study was not extensive enough to show the exact
changes in HbA1c. For external validity, the sample size of the study
was too small to be generalized to the population as many
participants did not follow the walking protocol (Suntornlohanakul et
31

al., 2020).
Measurements One day of each week the participants of groups recorded the food
diary and preformed self-monitoring blood glucose 6 times/day. The
participants visited the clinic at 0, 3, and 6 weeks of each intervention
to have blood tests completed including plasma glucose, hemoglobin
A1c, and fructosamine as well as self-monitoring blood glucose
records, accelerometer use and self-care (Suntornlohanakul et al.,
2020).
Data Analysis Multilevel mixed-effects linear regression was used for the analysis
of the normal distribution outcomes, a fixed effect model with
treatment, sequence, and period entered the model and subjects were
a random effect (Suntornlohanakul et al., 2020). The median
regression analysis was used for the non-normal distribution
outcomes (Suntornlohanakul et al., 2020).
Findings/Results In patients with type 2 diabetes who were being treated with basal
insulin, the HbA1c reduction by post-meal walking or one prandial
insulin injection were not different at 6 weeks (Suntornlohanakul et
al., 2020). Yet, shorter glycemic control was shown through
fructosamine levels but was not significant. This study found that
walking after meals may be equivalent to mealtime insulin
(Suntornlohankul et al., 2020). Recent research finds the
effectiveness of post-meal walking in reducing hemoglobin A1c
levels.
If Replication is Replication is possible. A bigger sample size would be needed for an
Possible extended period for the study. Also, a different walking protocol
could be used.
While researching our PICO question, we discovered many articles that were relevant to

our topic. Most of our articles had no theoretical or conceptual frameworks that were

identifiable. Theories are essential to nursing research to give direction and to approve or

disapprove a phenomenon being studied (Tappen, 2016). By having a scholarly foundation for

research, it can help provide structure to a research study by relating data to existing theories. A

framework can increase credibility, generalizability, objectivity, and reliability of the research

study (Tappen, 2016). Some of our research studies based their foundation on research programs

that were established with an attempt to replicate their findings. Dave et al. (2019) and Johansen

et al. (2017) used the Look Ahead Study created by the Action for Health in Diabetes. This

program is focused on the idea that type 2 diabetes can be reversible with diet and exercise as an

alternative model to implement into practice in place of drug therapy. The Look Ahead Study
32

uses diet and exercise to reduce weight to improve glycemic control and insulin sensitivity to

reduce the use of medical management and costs (Dave et al., 2019). Two other articles are

based on intensive lifestyle intervention programs including diet and exercise to improve care for

patients with type 2 diabetes. Lynch et al. (2019) used the Lifestyle Improvement through Food

and Exercise program as an intensive intervention to improve glycemic control in African

American patients with type 2 diabetes whereas Pot et al. (2019) used the Reverse Diabetes 2

program that enables diabetics to use skills through lifestyle interventions. Sampson et al. (2021)

was based on the Norfolk Diabetes Prevention Study that previously showed how added support

to diet and exercise can lead to improved patient outcomes. One study even created a new diet

and exercise program based on the World Free of Obesity and Diabetes campaign which was

named the Dixit diet (Dixit et al., 2022).

There were few conflicting studies to our PICO question which was if diet and exercise

achieved better glycemic control in type 2 diabetes compared to pharmacological therapy. Many

of the studies focused on diet and exercise interventions that can improve glycemic control by

reducing the incidence of antihyperglycemic medications and lowering hemoglobin A1c levels

(Pot et al., 2019). Our PICO question was supported as glycemic control was improved through

lifestyle interventions or diet and exercise in comparison to standard care in many of our articles.

One of our studies that did not specifically support our research study identified that oral

antidiabetic medications did improve glycemic control, but unhealthy eating habits and lack of

exercise led to poorer hemoglobin A1c levels (Afroz et al., 2019). A major theme in our

literature research was that diet and exercise programs led to greater weight loss which had a

positive impact on glycemic control. Some of our studies even found that diet and exercise can

lead to the remission of type 2 diabetes which was not seen with pharmacological therapy (Dixit

et al., 2022). Our literature search found articles that support most of our PICO question, but
33

many of the studies did not directly focus on the comparison of pharmacological therapy versus

lifestyle interventions. Based on the findings, we concluded that diet and exercise implemented

early can improve glycemic control for patients with type 2 diabetes over oral antidiabetic agents

(Sampson et al., 2021). More research is needed to compare diet and exercise as a safe

alternative to drug therapy.