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N Engl J Med. Author manuscript; available in PMC 2021 March 03.
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Published in final edited form as:

N Engl J Med. 2020 September 03; 383(10): 909–918. doi:10.1056/NEJMoa2007448.

Weight Loss in Underserved Patients — A Cluster-Randomized

Trial
Peter T. Katzmarzyk, Ph.D.,
Pennington Biomedical Research Center, Baton Rouge

Corby K. Martin, Ph.D.,

Pennington Biomedical Research Center, Baton Rouge
Author Manuscript

Robert L. Newton Jr., Ph.D.,

Pennington Biomedical Research Center, Baton Rouge

John W. Apolzan, Ph.D.,

Pennington Biomedical Research Center, Baton Rouge

Connie L. Arnold, Ph.D.,

Department of Medicine and Feist–Weiller Cancer Center, Louisiana State University Health
Sciences Center, Shreveport

Terry C. Davis, Ph.D.,

Department of Medicine and Feist–Weiller Cancer Center, Louisiana State University Health
Sciences Center, Shreveport
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Eboni G. Price-Haywood, M.D.,

Ochsner Clinic Foundation, Center for Outcomes and Health Services Research, Louisiana;
Ochsner Clinical School–University of Queensland School of Medicine, Louisiana

Kara D. Denstel, M.P.H.,

Pennington Biomedical Research Center, Baton Rouge

Emily F. Mire, M.S.,

Pennington Biomedical Research Center, Baton Rouge

Tina K. Thethi, M.D.,

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Address reprint requests to Dr. Katzmarzyk at the Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA,
70808-4124, or at peter.katzmarzyk@pbrc.edu.
We thank the patients and the members of the patient advisory boards, community monitoring board, and the project management
committee (Chris Lodge and Ava Zebrick, M.S.), who contributed greatly to the design and conduct of the trial; the trial patients,
assessment technicians, and health coaches, without whom this trial would not have been possible; Willie C. White III, M.P.H., and the
David Raines Community Health Centers; Gary Wiltz, M.D., and the Teche Action Clinic sites; Michael G. Griffin and Robert Post,
M.D., and the Daughters of Charity Services of New Orleans; the Ochsner Health System and Access Health Louisiana clinic sites; the
data and safety monitoring board (Robert Ross, Ph.D. [chair], John Lefante, Ph.D., Michael Rolfson, M.D., and Chris Lodge) for
overseeing patient safety and the overall conduct of the trial; and David B. Allison, Ph.D., Andrew W. Brown, Ph.D., Stephanie L.
Dickinson, M.S., and Lilian Golzarri-Arroyo, M.S., of the Indiana University School of Public Health–Bloomington for reviewing and
verifying the statistical methods and results of this project.
The statements in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-
Centered Outcomes Research Institute (PCORI) or its board of governors or methodology committee.
Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
A data sharing statement provided by the authors is available with the full text of this article at NEJM.org.
 Katzmarzyk et al. Page 2

Department of Medicine, Division of Endocrinology and Metabolism, Louisiana; Tulane University

Author Manuscript

Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System,
Louisiana

Phillip J. Brantley, Ph.D.,

Pennington Biomedical Research Center, Baton Rouge

William D. Johnson, Ph.D.,

Pennington Biomedical Research Center, Baton Rouge

Vivian Fonseca, M.D.,

Department of Medicine, Division of Endocrinology and Metabolism, Louisiana; Tulane University
Health Sciences Center School of Medicine, Southeast Louisiana Veterans Health Care System,
Louisiana

Jonathan Gugel, M.D.,

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Department of Medicine, Section of General Internal Medicine and Geriatrics, Louisiana

Kathleen B. Kennedy, Ph.D.,

College of Pharmacy, Xavier University of Louisiana, Louisiana

Carl J. Lavie, M.D.,

Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Louisiana;
Ochsner Clinical School–University of Queensland School of Medicine, Louisiana

Daniel F. Sarpong, Ph.D.,

College of Pharmacy, Xavier University of Louisiana, Louisiana

Benjamin Springgate, M.D.

Department of Internal Medicine, Louisiana State University School of Medicine, and Program in
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Health Policy and Systems Management, Louisiana State University School of Public Health, New
Orleans — Louisiana

Abstract
BACKGROUND—Evidence of the effectiveness of treatment for obesity delivered in primary
care settings in underserved populations is lacking.

METHODS—We conducted a cluster-randomized trial to test the effectiveness of a high-intensity,

lifestyle-based program for obesity treatment delivered in primary care clinics in which a high
percentage of the patients were from low-income populations. We randomly assigned 18 clinics to
provide patients with either an intensive lifestyle intervention, which focused on reduced caloric
intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group
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participated in a high-intensity program delivered by health coaches embedded in the clinics. The
program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the
remaining 18 months. Patients in the usual-care group received standard care from their primary
care team. The primary outcome was the percent change from baseline in body weight at 24
months.

RESULTS—All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care)
completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A

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total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group,
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and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had
an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the
24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-
lifestyle group (change in body weight, −4.99%; 95% confidence interval [CI], −6.02 to −3.96)
than in the usual-care group (−0.48%; 95% CI, −1.57 to 0.61), with a mean between-group
difference of −4.51 percentage points (95% CI, −5.93 to −3.10) (P<0.001). There were no
significant between-group differences in serious adverse events.

CONCLUSIONS—A high-intensity, lifestyle-based treatment program for obesity delivered in an

underserved primary care population resulted in clinically significant weight loss at 24 months.
(Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL
ClinicalTrials.gov number, NCT02561221.)
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OBESITY IS A DISEASE WITH A HIGH prevalence that has a major effect on public health in the
United States. Approximately 40% of American adults have obesity,1 which confers a
predisposition to type 2 diabetes, cardiovascular disease, cancer, and premature death.2-5
Health disparities in obesity also exist: the prevalence is higher among Black and Hispanic
adults than among White and Asian adults,6 and the prevalence is highest among adults in
some demographic groups with low income and limited education.7

The 2013 guideline of the American College of Cardiology, the American Heart Association
Task Force on Practice Guidelines, and the Obesity Society8,9 states that an intensive
lifestyle intervention is the centerpiece of effective weight loss. However, primary care
practitioners have been slow to adopt this approach.10 Concomitantly, the prevalence of
obesity has increased in the population, while the number of patients with obesity who
receive weight counseling from their primary care practitioners has declined substantially.11
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The sole reliance on primary care practitioners to deliver obesity treatment has limitations,
in part because of the limited time available during office visits,12 a lack of training in
behavioral therapy among primary care practitioners, and low reimbursement.13-15 Thus, the
investigation of different models to promote weight loss in primary care, especially in
underserved populations at high risk for obesity, is needed. We report the results of a cluster-
randomized trial that we conducted in an underserved population to test the hypothesis that
patients who receive a high-intensity lifestyle intervention, tailored to the health-literacy
level of the population, would have greater weight loss than patients who receive usual care.

METHODS
TRIAL DESIGN AND OVERSIGHT
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The Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) trial was a
cluster-randomized, two-group trial conducted in 18 primary care clinics that served racially
diverse, low-income populations across Louisiana.16 Clinics were randomly assigned to
provide patients with either an intensive lifestyle intervention or usual care. All the patients
provided written informed consent, and the protocol (published previously16 and available
with the full text of this article at NEJM.org) was approved by the institutional review board
of the Pennington Biomedical Research Center. Health and Nutrition Technology (Carmel,

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CA) provided the HealthONE formula, and Nutrisystem (Fort Washington, PA) provided the
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meal-replacement products for patients in the intensive-lifestyle group. Trial data were
collected and managed with the use of Research Electronic Data Capture (REDCap)17 tools
hosted by the Pennington Biomedical Research Center.

The trial was designed by 13 of the authors, and data were collected by 6 of the authors in
collaboration with research coordinators. The first author wrote the first draft of the
manuscript, with input from all authors, and vouches for the accuracy and completeness of
the data and for the adherence of the trial to the protocol. All the authors approved the
submission of the manuscript for publication.

PATIENTS AND TRIAL GROUPS

The primary inclusion criteria included an age of 20 to 75 years and a body-mass index (the
weight in kilograms divided by the square of the height in meters) of 30 to 50. Exclusion
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criteria included current participation in a weight-loss program, use of weight-loss

medications, and a history of bariatric surgery or recent weight loss. Full eligibility criteria
are provided in the protocol.

Patients were recruited into the intensive-lifestyle group or the usual-care group according to
the random assignment of the clinic. Detailed descriptions of the interventions in the two
groups have been published previously.16 In brief, the intensive intervention was adapted
from the Diabetes Prevention Program (DPP),18 Action for Health in Diabetes (Look
AHEAD),19 and Comprehensive Assessment of Long-term Effects of Reducing Intake of
Energy (CALERIE) trials20 and consisted of weekly sessions (16 conducted in person and 6
conducted by telephone) in the first 6 months, followed by sessions (alternating in-person
visits and telephone calls) held at least monthly for the remaining 18 months (Table S1 in the
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Supplementary Appendix, available at NEJM.org). Most sessions were conducted

individually, although some sessions were conducted in small groups of two to four patients,
depending on patient preference and scheduling availability. All the interventions were
adapted to be appropriate for the health-literacy level of the trial population through
extensive consultation with our patient advisory boards.21,22 The intensive intervention was
delivered by health coaches embedded in primary care clinics. At a minimum, coaches had
academic degrees related to nutrition, physical activity, and behavioral medicine and
underwent an initial 1.5-day training session and yearly retraining. Weekly case-
conferencing webinars attended by the coaches and the research team were held throughout
the trial.

For patients in the intensive-lifestyle group, the personal goal was a 10% loss in body
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weight; patients received coaching on how to set their own goals and develop action plans
for eating and physical activity. Patients were encouraged to increase their physical activity
to 175 minutes per week.16 The initial focus of the intervention was on portion-controlled
foods (e.g., bananas, apples, soups, and frozen entrees) and the provision of prepackaged
foods and meal-replacement shakes during the first month. After the first month, patients
received instruction regarding how to purchase, prepare, and package foods to manage
portion size and energy intake in collaboration with their health coaches. A weight-loss
calculator was used to calculate personalized energy-intake targets for each patient that

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would result in 10% weight loss at 6 months and was then used to create a weight graph that
showed each patient’s predicted weight loss over time.16,23 Patients were provided with an
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electronic scale (BodyTrace) and were encouraged to weigh themselves daily. The daily
weights were automatically plotted onto the weight graph, which was available to patients
and their health coaches and allowed the coaches to monitor weight loss and adapt the
intensity of the intervention.16

Primary care practitioners of patients in the intensive-lifestyle group attended a series of five
webinar presentations, which included information on the management of obesity, the
management of coexisting conditions such as type 2 diabetes and hypertension,
minimization of bias and stigma related to obesity, and principles of health literacy.

Patients in the usual-care group received routine care from their primary care team
throughout the trial. In addition, they received six newsletters covering topics related to
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sitting and health, goal setting, staying safe in the heat, memory health, self care, sleep
hygiene, and smoking cessation. Primary care practitioners of patients in the usual-care
group attended a seminar and received a brochure, both of which described weight
management in primary care and the current Centers for Medicare and Medicaid Services
approach to reimbursement for obesity treatment.24

OUTCOMES
Outcomes were assessed at baseline and at the visits at 6, 12, 18, and 24 months. The
primary outcome was the percent change in weight from baseline at 24 months. Secondary
weight-related outcomes included the change in absolute weight (in kilograms) and the
change in waist circumference (in centimeters). Additional secondary outcomes included
risk factors for cardiovascular disease and patient-reported outcomes.16 Body weight was
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measured with a digital scale to the nearest 0.1 kg, and waist circumference was measured to
the nearest 0.1 cm with the use of an anthropometric tape placed midway between the lower
rib margin and the iliac crest, after gentle expiration.

STATISTICAL ANALYSIS
With an enrollment target of 18 clinics with an average of 45 patients recruited per clinic, we
hypothesized that the trial would have a minimum power of 80% to detect a 3.5-
percentagepoint difference in the primary outcome at 24 months between the intensive-
lifestyle group and the usual-care group for the planned subgroup analyses.16 The total
sample size would provide at least 97% power to detect a mean percent weight loss at 24
months in the intensive-lifestyle group that was 3.5 percentage points greater than that in the
usual-care group. The type I error rate was 0.05 for two-sided hypothesis testing. All
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analyses were conducted with the use of SAS software, version 9.4 (SAS Institute).

The outcomes at 6, 12, 18, and 24 months were analyzed in the context of repeated-measures
linear mixed-effects multilevel models, which included random cluster (clinic) effects. In
addition to trial group, assessment time, and their interaction terms, the models included age,
sex, and race as covariates. We performed intention-to-treat analyses, which included all
patients (regardless of the number of assessments obtained) and used the restricted
maximumlikelihood method. The model assumed that missing values were missing at

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random, and all values presented in the tables and figure are model-based estimates. Three
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subgroup analyses were prespecified to examine the heterogeneity of treatment effects

(Black or other race; sex; and younger age [21 to 42 years], middle age [43 to 56 years], or
older age [57 to 74 years]). In the intensive-lifestyle group, the associations between the
amount of intervention session material received and outcomes were analyzed by assessing
data for patients who received less than 80% and for patients who received 80% or more of
the materials with the use of models that included age, race, sex, and baseline weight as
covariates. The arbitrary cutoff of 80% was prespecified. Finally, categorical weight loss was
analyzed by comparing the percentage of patients who had 5% or more weight loss with the
percentage of patients who had 10% or more weight loss at each assessment with the use of
generalized linear mixed models. Chi-square tests conducted at each time point and overall
were used to compare serious adverse events between the groups.
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RESULTS
CLINICS AND TRIAL PATIENTS
All 18 clinics completed 24 months of participation in the trial from April 2016 through
September 2019. The final number of patients enrolled in each clinic ranged from 2 to 89,
with a median of 40.5 patients per clinic. A total of 803 adults with obesity were enrolled;
452 patients were assigned to the intensive-lifestyle group, and 351 were assigned to the
usual-care group. A total of 540 patients (67.2%) were Black, and 678 (84.4%) were
women. The two cluster-randomized groups were well balanced with respect to baseline
characteristics; however, there was a greater proportion of Black patients and women in the
intensive-lifestyle group (Table 1). There were no differences in the clinical measures at
baseline between the usual-care group and the intensive-lifestyle group, although there was a
greater proportion of patients with diabetes in the usual-care group. A total of 670 patients
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(83.4%) in the trial population (362 of 452 [80.1%] in the intensive-lifestyle group and 308
of 351 [87.7%] in the usual-care group) had data available on body weight at 24 months
(Fig. S1). A total of 36 patients did not have complete data because of medical reasons: 18
became pregnant (8 in the intensive-lifestyle group and 10 in the usual-care group), 4 had
weight-loss surgery (2 in each group), a major medical condition developed in 11 (7 in the
intensive-lifestyle group and 4 in the usual-care group), and 3 died (2 in the intensive-
lifestyle group and 1 in the usual-care group) during the trial; data for these patients were
included up to the time of the medical event. After exclusion of these patients, 87.4% of the
patients (670 of 767 patients) had data available for weight measurements at 24 months.

WEIGHT LOSS
The primary outcome was the percent change from baseline in body weight at 24 months.
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Patients in the intensive-lifestyle group lost significantly more weight (change in body
weight, −4.99%; 95% confidence interval [CI], −6.02 to −3.96) than patients in the usual-
care group (−0.48%; 95% CI, −1.57 to 0.61), with a mean difference of −4.51 percentage
points (95% CI, −5.93 to −3.10) between the groups (P<0.001). The intraclass correlation
for the cluster (clinic) effect on the magnitude of weight loss at 24 months was 0.14. The
greatest weight loss in the intensive-lifestyle group occurred at 6 months; however, clinically
significant weight loss was maintained at 24 months (Table 2). Similar results were observed

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for changes in absolute weight and waist circumference. Table S2 provides the results from
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analyses of unadjusted models and models adjusted for patient-level and clinic-level
covariates, including baseline weight. The results from all analyses were similar.

The results of the subgroup analyses are shown in Figure 1. The percent weight loss in the
intensive-lifestyle group tended to be less among Black patients than among patients of
other races, and the difference between the two groups across all outcomes was at least 1
percentage point less among Black patients at 24 months (Table S3). Women and men in the
intervention group lost a similar amount of weight (Table S4). There appeared to be a dose–
response association with age, with younger adults having a smaller magnitude of weight
loss than older adults in the intensive-lifestyle group. However, differences in weight loss
between the two groups were similar across age categories (Table S5).

A total of 248 of 362 patients (68.5%) in the intensive-lifestyle group who had their weight
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measured at 24 months attended at least 80% of the intervention sessions. The percent
change in body weight among patients who attended at least 80% of sessions in the
intensive-lifestyle group was −7.07% (95% CI, −8.58 to −5.56) at 24 months, as compared
with −1.93% (95% CI, −3.81 to −0.06) among those who attended less than 80% of the
sessions (Table S6).

Categorical weight-loss results are shown in Figure S2. At 24 months, 19.6% of the patients
(95% CI, 12.9 to 28.7) in the usual-care group had at least 5% weight loss, and 4.7% (95%
CI, 2.6 to 8.4) had at least 10% weight loss. In the intensive-lifestyle group, 50.7% of
patients (95% CI, 39.8 to 61.5) had at least 5% weight loss, and 23.2% (95% CI, 16.5 to
31.7) had at least 10% weight loss (the group that had ≥10% weight loss also includes
patients who had ≥5% weight loss).
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CHANGES IN SECONDARY OUTCOMES

Characteristics with respect to risk factors for cardiovascular disease and other quality-of-
life outcomes in the two groups were similar at baseline (Tables S9 and S10). There was
more improvement in several quality-of-life measures among patients in the intensive-
lifestyle group than among those in the usual-care group, whereas changes from baseline in
risk factors for cardiovascular disease were minimal in the two groups (Tables S7 and S8).

ADVERSE EVENTS
A total of 86 patients had at least one serious adverse event during the trial (Table 3); 83
patients reported hospitalizations or other life-threatening conditions, and 3 patients died
during the trial. None of the serious adverse events were considered by the investigators to
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be related to the trial interventions. There were no significant differences in serious adverse
events between the groups overall or at any time point.

DISCUSSION
The results of this trial show the effectiveness of a high-intensity, lifestyle-based obesity
treatment program, developed to be consistent with the 2013 guideline of the American
College of Cardiology, the American Heart Association Task Force on Practice Guidelines,

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and the Obesity Society,8,9 in an underserved primary care population. The intensive-
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lifestyle group had an average weight loss of 5%, and 51% of the patients maintained at least
5% weight loss at 24 months. Our results are similar to those of studies conducted in
academic health centers, such as the DPP25 and Look AHEAD26 trials, which showed 5.8%
and 6.4% weight loss at 24 months, respectively, in their lifestyle-intervention groups. Low-
intensity to moderate-intensity interventions used by primary care practitioners have
produced minimal weight loss (1 to 2 kg).14,27 However, high-intensity interventions
conducted in primary care settings can result in greater weight loss (4 to 7 kg).27 For
example, in the Practice-based Opportunities for Weight Reduction (POWER) trials in
Baltimore, Boston, and Philadelphia, participants who received lifestyle interventions had
average weight losses of 5.2%, 1.7%, and 4.7%, respectively, at 24 months.28-30

Our results showed that Black patients had slightly less weight loss than patients of other
races (primarily less than White patients). This is consistent with evidence from several
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trials,31 such as the Look AHEAD trial (in which Black patients lost less weight than White
patients at 2 years26) and the DPP trial (in which Black women lost less weight than men
and women of other races and ethnic groups32). Differences in body composition and
metabolism may play a role in the observed differences in weight loss among patients of
various races.33,34 The smaller weight loss among Black patients may also be the result of
less behavioral change and lower engagement with interventional components.35 Given
these factors, and given that psychological predictors of weight loss have been reported to
differ according to race,36 interventions may need to be tailored specifically for Black
patients in order to increase weight loss.

Although previous studies have shown greater weight loss among men than among women,
37 we did not identify any differences according to sex. Weight loss among men and women
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in the intensive-lifestyle group was almost identical. These results also do not support those
of the Look AHEAD trial, in which men had greater weight loss than women at 2 years.26

The results in the intensive-lifestyle group showed that older adults had greater weight loss
than younger adults. These results support those observed in the intensive-lifestyle group in
the DPP trial: older patients were more likely than younger patients to meet the 7% weight-
loss goal at 2 years.38 Similarly, in the intensive-lifestyle group in the Look AHEAD trial,
successively older age groups had significantly more weight loss than younger age groups.26
However, in our trial, older adults in the usual-care group also lost more weight than
younger adults, so the difference in weight loss between the two groups was not associated
with age. Therefore, it is possible that age-related weight loss in the overall cohort of
patients (both groups) may explain why older patients lost more weight than younger
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patients in the intensive-lifestyle group, and that this association was not an age-specific
response to the intervention.

Our trial has certain strengths and limitations. A major strength is the diverse sample of
clinics and patients from urban and rural regions of Louisiana, which represents an
underserved population that has not generally participated in clinical research. The results of
the current trial apply broadly to the large underserved, low-income population in the United
States, which faces important barriers to receiving effective treatment for obesity. Another

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strength is the incorporation of a health coach into the collaborative care team, which is a
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potential model for weight-loss programs in primary care.

A limitation of the trial is the predominance of women in our sample (84%), which limited
our ability to study weight loss in subgroups according to sex and race. However, our trial is
not unique in this regard — women have made up 73% of the populations in lifestyle-based
weight-loss interventions.39 Weight changes among patients with missing weight
measurements also may have been systematically different from those with data for weight
measurements, and this could be a potential source of bias. For example, if patients in the
intensive-lifestyle group who were missing data at follow-up lost less weight than those who
had their weight measured, this would provide an overestimation of the treatment effects.
Finally, our analysis of receipt of session materials is equivalent to an observational study
with covariate adjustment, and unmeasured variables could explain differences between the
groups.
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As compared with usual care, a high-intensity, lifestyle-based treatment program for obesity
delivered with the addition of a health coach resulted in significant weight loss over 24
months in an underserved primary care population.

Supplementary Material
Refer to Web version on PubMed Central for supplementary material.

Acknowledgments
Supported by an award (OB-1402-10977) from PCORI, by a grant (U54 GM104940) from the National Institute of
General Medical Sciences of the National Institutes of Health, which funds the Louisiana Clinical and Translational
Science Center, and by a grant (“Nutrition and Metabolic Health through the Lifespan” [P30DK072476]) from the
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Nutrition and Obesity Research Center, sponsored by the National Institute of Diabetes and Digestive and Kidney
Diseases.

Dr. Katzmarzyk reports receiving donated supplies from Health and Nutrition Technology and Nutrisystem and
grant support, paid to Pennington Biomedical Research Center (PBRC), from PCORI; Dr. Martin, Dr. Martin,
receiving grant support, paid to PBRC and Louisiana State University (LSU), from the Egg Board and Access
Business Group, advisory board fees from EHE Health and NaturallySlim, consulting fees from Florida Hospital,
Gila Therapeutics, Metagenics, Openfit, and Zafgen, supplies donated to PBRC and LSU from Health and Nutrition
Technology and Nutrisystem, grant support, paid to PBRC and LSU, and advisory board fees from WW, grant
support, paid to PBRC and LSU, and fees for serving as a trainer from the Academy of Nutrition and Dietetics, and
holding patents (15/946841 and TW201837799A) on a body-weight management and activity tracking system and
a trademark (4,777,567;SN 85-764,888), held by PBRC and LSU and licensed to Access Business Group; Drs.
Newton and Apolzan, receiving donated supplies from Health and Nutrition Technology and Nutrisystem and grant
support, paid to PBRC, from PCORI; Dr. Arnold, receiving grant support, paid to LSU Health Sciences Center,
from PBRC; Dr. Price-Haywood, receiving grant support, paid to Ochsner Clinic Foundation, from PBRC; Ms.
Denstel, receiving donated supplies from HealthONE and Nutrisystem and grant support, paid to PBRC, from
PCORI; Ms. Mire, receiving donated supplies from Health and Nutrition Technology and HealthONE and grant
Author Manuscript

support from PCORI; Dr. Thethi, receiving grant support from Tulane University; Dr. Fonseca, receiving consulting
fees from Abbott Diabetes Care, Asahi Group Holdings, Bayer, Novo Nordisk, Sanofi US Services, and Takeda
Development Center Americas, and holding a pending patent (62/676273) on the Building, Relating, Assessing, and
Validating Outcomes (BRAVO) risk engine; and Dr. Lavie, receiving grant support, paid to Dr. Katzmarzyk, from
PBRC. No other potential conflict of interest relevant to this article was reported.

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Figure 1. Mean Percent Change in Weight from Baseline.

Shown is the percent change in weight according to race (Panel A), sex (Panel B), and age
group (Panel C). Patients in the intensive-lifestyle group participated in a high-intensity
lifestyle program for obesity treatment that focused on reduced caloric intake and increased
Author Manuscript

physical activity. Patients in the usual-care group received standard care from their primary
care team.

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Table 1.

Characteristics of the Clinics and the Patients at Baseline.*

Intensive-Lifestyle
Variable Group Usual-Care Group Overall
Clinics
Katzmarzyk et al.

No. of clinics 9 9 18

Clinic size — no. of adult patients 5184 7994 6589†

Clinic type — no. of clinics (%)
Federally qualified health center 7 (77.8) 7 (77.8) 14 (77.8)
Other 2 (22.2) 2 (22.2) 4 (22.2)

Race of clinic patients — %‡

Black 62.9 49.7 56.3†

Other 37.1 50.3 43.7†

Patients receiving Medicaid — % 24.5 27.7 26.1†

Patients
No. of patients 452 351 803
Age — yr 48.8±12.7 50.1±13.6 49.4±13.1

Body-mass index§ 37.3±4.6 37.2±4.8 37.2±4.7

Race — no. (%)¶

Black 332 (73.5) 208 (59.3) 540 (67.2)
White 95 (21.0) 113 (32.2) 208 (25.9)
Other 25 (5.5) 30 (8.5) 55 (6.8)

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Ethnic group — no./total no. (%)¶
Hispanic 18/451 (4.0) 14/351 (4.0) 32/802 (4.0)
Non-Hispanic 433/451 (96.0) 337/351 (96.0) 770/802 (96.0)
Sex — no. (%)
Male 54 (11.9) 71 (20.2) 125 (15.6)
Female 398 (88.1) 280 (79.8) 678 (84.4)
Annual family income — no./total no. (%)
<$10,000 86/445 (19.3) 70/341 (20.5) 156/786 (19.8)
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Intensive-Lifestyle
Variable Group Usual-Care Group Overall
$10,000–$19,999 95/445 (21.3) 73/341 (21.4) 168/786 (21.4)
$20,000–$39,999 112/445 (25.2) 79/341 (23.2) 191/786 (24.3)
$40,000–$59,999 69/445 (15.5) 48/341 (14.1) 117/786 (14.9)
≥$60,000 83/445 (18.7) 71/341 (20.8) 154/786 (19.6)
Katzmarzyk et al.

Health-literacy level — no. (%)∥

≤8th grade 141 (31.2) 106 (30.2) 247 (30.8)
≥9th grade 311 (68.8) 245 (69.8) 556 (69.2)
Household food-security status — no. (%)
Secure 323 (71.5) 233 (66.4) 556 (69.2)
Insecure 129 (28.5) 118 (33.6) 247 (30.8)
Diabetes — no. (%) 103 (22.8) 104 (29.6) 207 (25.8)
Body weight — kg 101.6±16.4 102.7±17.0 102.1±16.7
Waist circumference — cm 113.1±12.4 113.9±12.6 113.4±12.5

*
Plus–minus values are means ±SD. Percentages may not total 100 because of rounding.
†
The value is the mean.
‡
Race was reported by the clinic.
§
The body-mass index is the weight in kilograms divided by the square of the height in meters.
¶
Race and ethnic group were reported by the patients.
∥
Health-literacy level was determined with the use of the Rapid Estimate of Adult Literacy in Medicine (REALM) Short-Form questionnaire.16

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Table 2.

Change in Weight-Loss Variables over 24 Months.*

Variable Intensive-Lifestyle Group Usual-Care Group Difference

Percent change in body weight (95% CI)
Katzmarzyk et al.

At 6 mo −7.34 (−8.23 to −6.45) −0.47 (−1.40 to 0.46) −6.86 (−8.05 to −5.68)†

At 12 mo −6.75 (−7.72 to −5.78) −0.59 (−1.61 to 0.43) −6.16 (−7.47 to −4.85)†

At 18 mo −5.62 (−6.61 to −4.63) −0.40 (−1.44 to 0.64) −5.22 (−6.57 to −3.88)†

At 24 mo −4.99 (−6.02 to −3.96) −0.48 (−1.57 to 0.61) −4.51 (−5.93 to −3.10)†

Change in body weight — kg (95% CI)
At 6 mo −7.81 (−8.77 to −6.85) −0.83 (−1.82 to 0.17) −6.98 (−8.26 to −5.71)
At 12 mo −7.22 (−8.25 to −6.19) −0.99 (−2.08 to 0.09) −6.23 (−7.63 to −4.83)
At 18 mo −6.07 (−7.12 to −5.02) −0.82 (−1.92 to 0.29) −5.26 (−6.69 to −3.82)
At 24 mo −5.43 (−6.52 to −4.34) −0.91 (−2.07 to 0.24) −4.51 (−6.01 to −3.02)
Change in waist circumference — cm (95% CI)
At 6 mo −6.84 (−7.75 to −5.93) −0.99 (−1.93 to −0.05) −5.85 (−7.04 to −4.66)
At 12 mo −6.63 (−7.61 to −5.66) −0.68 (−1.70 to 0.33) −5.95 (−7.25 to −4.65)
At 18 mo −5.33 (−6.32 to −4.34) 0.21 (−0.82 to 1.24) −5.54 (−6.86 to −4.22)
At 24 mo −4.42 (−5.44 to −3.41) 0.71 (−0.35 to 1.78) −5.13 (−6.50 to −3.77)

*
All models included age, sex, and race as covariates.
†
The difference is the difference in percentage points.

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Table 3.

Serious Adverse Events.*

Event Baseline to 6 Mo >6 to 12 Mo >12 to 18 Mo >18 to 24 Mo Total

number of patients
Katzmarzyk et al.

Hospitalization for life-threatening event

Intensive-lifestyle group 9 19 21 8 48
Usual-care group 8 10 11 10 35
Death
Intensive-lifestyle group 0 0 1 1 2
Usual-care group 1 0 0 0 1

*
Shown are the number of patients with at least one serious adverse event at each time point. Patients may have had a serious adverse event at more than one time point.

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