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    Jurnal Pendukung 1

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    effects of nutritional education on weight change and metabolic abnormalities among patients with schizo in Japan

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    Jurnal Pendukung 1

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    effects of nutritional education on weight change and metabolic abnormalities among patients with schizo in Japan

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    effects of nutritional education on weight change and metabolic abnormalities among patients with schizo in Japan

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    Jurnal Pendukung 1

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    M S
    effects of nutritional education on weight change and metabolic abnormalities among patients with schizo in Japan

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    Jona Peete Rseth 37 (2018) 7-89 Contents lists available at ScienceDirect, Journal of Psychiatric Research journal homepage: wivw.clsevier.comilocstelipsychires ELSEVIER Effects of nutritional education on weight change and metabolic abnormalities among patients with schizophrenia in Japan: A randomized 28! controlled trial Norio Sugawara””**, Toyoaki Sagae*, Norio Yasui-Furukori™*, Manabu Yamazaki’, ‘Kazutaka Shimoda", Takao Mori’, Takuro Sugai", Hiroshi Matsuda’, Yutaro Suzuki", Yuji Ozeki", Kurefu Okamoto’, Toshiyuki Someya®" Deparment Cel pel, rena Mal Cee, National Caer of lg andreas 4 1 gona gah Kedar Cy Toys 18751 den iparmet f Nepcay, Hrs Unb Ss of Me, 5 Zand, Hil Cy Anmort, 036-8562, Japan “lepanse Sc of cl Naepechphamaclig 2 Sanbanche, Chas Toy, 12.0075 Jaan “Deparment of Heath an Maron Yamagar PrerelYorraa Une of Maron Scenes 6151 Tormac Yenezawe Ci, Yona 992025 Jean ‘apa Pra Det Acro £17.71 Ramone bas, Tle, 173097, Japan ‘apan Pars Hoel, 31514 Soar Mas a, Tuk, 184554 ae Deport f Prey, Dato edie Univesty Scot of Medi. 640 Kbyte $21-0293, dopa Deparment of Peay, Mig Unvented Sho of Mell an Dl Ses 1-757 Anahi, Chk Mig, 95-510 Jan ABSTRACT ‘Objet: Patients with sehzophenia havea higher prevalence of metablie syndrome (Mets) than the general population Minimizing weight gain and metabolic abnormalities in « population with an already high pre- ‘valence of best sof lniel and seal importance. This randomized controlled ial investigated the effet of ‘onthiy titinal education on weight change and metabolic cbnormalites among patients with sthze- Dhrenia in Japan “Methods: From July 2014 to December 2014, we rcree 265 obese patient who ad a DSMV diagno of chizoaffecsive dvorder,Parkpante were randomly sargned to « andard care (A), doctors ice (or an individual mattional education group (6 or 12 months. The prevalence of Me sod body weight were mearred at barline and 12 month Renu After the T-month ereatment, 182 patients were evakated, and the prevalence of Mets bated on the [ATP TILA definition in groupr A,B, and C was 58.9%, 67.2% and 473%, respectively. Group C showed i= ‘creased weight low (22 = 4.5 kg) over the 12-month study period, and the change fo weight difered sige ‘scaly from tha of group A adtonally, 25.2% f the parepant ingroup Clan 7% or more af thei nial ‘weight compared with 8.2 of those in group A ‘Gonluion Individual auton eduction provided by a detitan vas highly successful la reducing obesty Daets with schizophrenia and coud be the fst choke to address both weight gain and metabolic abnor ‘les indeed by antipsyehote medias 1, Introduction Antipychotic medications have long been known to generate me ‘bolic abnormalities including weight gain, and patients with schizo- pphrenia have shown a higher prevalence of metabolic syndrome (MetS) than the general population (Yesui-Furukor! et al, 2009; Sugawara ‘et al, 2010; Sugai ct al, 2012), Although the eauses of metabolic ~ corvspanng autor, Departmen a nel penile Tas Ema adie: noussi@yshoocajp (N. Sugamar) psf ee 10 1016 psehies2017 12.002 adverse events are complicated, the risk factors among patients with schizophrenia can be attributed to dietary patterns (Sugawara etal 2014; Tsoruge et al, 2075), negative symptoms of schizophrenia (GicrasMainar ct al, 2014), and physical activity as well as ant Dsyehotie medications (Vancampfort et al, 2013). Metabolic adverse fevents, which are widely considered « major risk factor for eatdiovae cular disease (Isomaa etal, 2001; Lakka et al, 2002), and mortality ea ect, Nol Cn esogy an Peay, 41-1 Opener Koda, Tok 187 ec 4 Speer 207, Rtv in eed frm 24 November 27; cepted 1 Deceser 27 (Wu et al, 2010; Laursen, 2011), are of increasing concern among patients with schizophrenia The mental health eae system in Japan remains hospital-based and hhas the largest number of paychistric beds per person in the world Osiisty of Healt, Labour and Welle, 2008), AS palents in Japan have the longest peychiatric hospital stay of developed nations, en- vironmental factor, such as physical activity and diet, could differen Wally afec the development of MetS in inpatients and outpatients, Our previous study revealed thatthe prevalence of MetS in Japan was ap- proximately 3 times higher in outpatients than in inpatients (Susai etal, 2016), Serious discussions about the deinstitutionalization ofthe Japanese mental health system began several years ago. Although the ShiR from inpatient eare to community-based care isan ongoing chal lenge, the discharge of longterm psychiatric inpatients should be ac- ‘companied by clinical management to protect against weight gain and metabolic abnoemalties, ‘Non-phatmacclogical interventions for weight gsin and metabolic sbnormalities are a potential solution to address metabolic abnormal ites in patients with schizophrenia (Papanastasiov, 2010). A recent meta-analysis showed that behavioral interventions including nutei- onal education effectively prevented and reduced antipaychoticasso ciated weight gain and metabolic abnormalities (Caemmerer etal 2012). Effective and feasible educational interventions are needed for ‘outpatients with schizophrenia in Japan's mental health system, a8 ‘these patents are at high risk of Met. Tae purpose ofthis randomized controlled study was to determine ‘whether a 12-month individual nutritional education program provided bya dietton could reduce body weight and metabolic abnormalities in patients with schizophrenia. To our knowledge, thie the fret stad to investigate the effect of nutritional education in patients with schizo- prenta in Japan, 2, Method 2:1, Procedure The joint committee of the Japanese Society of Clinical Newropsyehopharmacology and the Japan Paythiatric Hospitals ‘Assocation for antipsychotic treatment and physical rick organized thie study, Subjects were recruited in oxtpatient setting, and all pat pants were outpatients when commencing the study. The Ethics ‘Committee ofthe Japan Psychiatrie Hospitals Assocation approved the study procedure. All respondents provided written informed consent to Parsicipate in thie study and did not receive any incentives. lof the Parscipante were diognoced with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), oF the Incermational Classification of Diseases, tenth revision {ACD-10). Information on subject! demographie characteristics (age, sex) and medical history was obtained from their medical records. We Included obese patients (body mast index (BMD) = 25 or waist c= ‘eumference = 90 em for males and 280 em for females) between 20 and 65 years old. Subjects had (o be stabilized and treated with an antipsychotic drug fora east thzee months. Those who had conditions likely to significantly affect the rerlts of the interventions (eg, dis betes, a current or previous diagnosis ofan eating disorder or alcobol/ substance abuse, and mental retardation, were excluded. Subjects who shad received individual nutritional education in the past year were also ‘excluded from the study. Concomitant medications for residual and breakthrough symptoms were allowed at the clinician's discretion. 2.2, Protocol The protocol was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials ——-Registy (UMIN000014015). The partiipants were randomly sssgned to a standard care (A), doctors weight loss advice (B), of an individual Jel of ae Research 97201) 77-83 nutritional edueation group (C) using the envelope method 23. Intervention Participants in groupe B and C were provided weight loss advice from the attending psychiatrists. They received a study notebook to record their body weight to create a shared understanding between patients and psychiatrists, At baslin, the participants were informed of their target body weight. At every office vst their body weight was ‘measured, and the attending psychiatrists provided brief advice focused, lon the numeric increste or decrease in their body weih ‘The individual nutritional education group (group ©) received one on-one nutrition education sessions over a 12-month period. The ses sions were conducted on a monthly basis by dietitians who were members of and certified by the Japan Psychiatric Dietetic Association. The educational program was based on the Nutrition Needs in Payehiatry (NNP) project (Sagas, 2007). The program consisted of four ‘phases, and the Teaming objectives of each phase were as follows: [1] understanding the composition ofa alanced mea, [2] understanding appropriate food requizements, [3] reducing the consumption of snacks, and (4] reviewing the sessions. Each phase comprised three sessions lasting 30-40 min each, Dietary energy goals were based on caleulating the participants’ eal body weight (kg) mes 25 kcal During the study, the participants maintained daly food records. The dietitians reviewed and discussed the food records with each patient and alzo practiced selecting foods using fullsized sample dish cards GGonyosha Ine, Tokyo, Japan) (Sptze, 1972; Matsushite and Adachi, 2000) Duaring the inital three months, the subjects were advised to have tee regular meals a day and to eat balanced meals based on a staple food, # main dish, and a side dish that included vegetables or dsity products. In the second phase, the sessions included ¢iscussions be- tween the participant and the dietitian about their understanding of appropriate food requirements. One of the focuses in this phase was establishing the participants consumption of staple foods such as wheat, maize, and rice, the progression of which was reviewed and revised on a seléreport basis. In the third phase, the participants were educated about the relationship between weight gain and eating snacks ‘Their curent snack intake was monitored on a selézeport bars, and they were also advised to avoid consuming sacks. To reinforce the ‘nuuitional education, the participants reviewed the content of phases 1 to2 with the dietitians and aimed to achieve their deal weight in phase 4 During this intervention, group A received standard eare for re- sidual and beeakth:ough symptoms of schizophrenia. As for nutritional education or weight loss advice, this group received no comparison treatment a€ all during the study, Blinding of participants and psy ehlatests was not possible given the nature ofthe study 24, Outcomes The height and weigh of the subjects were measured, and their BMI was calculated. Waist citcmference was measured to the nearest 0.1 cm at the umbilical level while in 2 standing position, and the ‘measurements were obtained bythe technician in the morning, Trained technicians meesured blood pressure (BP) wsing standard mercury sphygmemenometers on the right arm of seated participants ater 5 min of rest. High-density lipoprotein cholesterol (HDL-C), tglyeerides (76), fasting blood glucose, and hemoglobin Ale (HALE) were also measured by standard snalytiesl techniques. The presence of MetS was decermined according. to the definitions of the adapted National Cholesterol Fdueation Program Adult Treatment Panel Ill (ATP II-A) rable D, Juul of ae Research 97 201) 77-83 nae wo 103 we 36 wwe 109 ons Dection of ection ae) ns 2 Bo 2 hs xo ae Gendered) ora sen wes aus pay ‘as 04st Preparing own meas 458 2739) 323 eas) 850 (33/60) ose Pat iney of pees ns ws tat ono be was bose ato of 30h ey os Gusn, es en Be a 79 263 patients erred & rndaraton ‘Groop A Group B ‘Group ¢ os 193 a 24 pains daconsinued 26 pacts discontinued 26 patos discontinued 61 paints competed 67 paints completed 61 patients completed 1 year followup yee fallow T year fillownup 2.5. Hypotheses We hypothesized that at 12 months postrandomization, group C ‘and group B would report greater reductions inthe prevalence of MetS ‘than group A. Furthermore, we hypothesized that group Cand B would show some reductions in body weight and that the reductions in group B would be greater than these ingroup A but less than those in group C. 26 Statistical analysis [An estimation of the effect sizes was necessary due to the lack of ‘comparable nutritional eduestion studies addressing Mets in patients ‘ith schizophrenia, Based on expert opinion, we postulated a medium effect size of ~ 0.3 for the éifference between study arms in the prevalence of MetS at 12 months postrandomization. Because an at teition rate of approximately 40% was expected, we aimed to include at least 235 participants from all 42 hospitals. This sample size would alow us to detect an effet size of @ = 0.3 based on a power (1 - ) of 90% and aa «error of 0.05 in a cwostided test, calculated using rPower software The analysis was performed on a “per protocol” or “on-reatment basis (only patticipants who completed the protocol were included: nn = 189 completers), To ensure group comparability, baseline socio demographic and clinical characteristics were tested using one-way analysis of variance (ANOVA) for continuous variables and chi-square test for categorical variables, Within-group comparisons were explored ‘sing palced sample tests Co examine significant changes in measures from baseline to after 12 months of intervention for each group. The relationthip betveen the main outcomes (prevalence of MetS at 12 ‘months post-andomization) was investigated by chi-square tet, The relationship between the change in each parameter and the interven tion was asessed sing a general linear model (GLMD. Under both per protocol and baseline observation carried forward (BOCF) basis, change in each parameter from baseline to follow-up was wsed as the depen- deat variable, the type of intervention asthe independent variable, and sex, age, baseline data of BMI, Systolic BP, and HDL-C as covariates. ‘When the analysis revealed significant between-group effets, adi- Luonal post hoe analysis (Bonferroni method) was conducted. Statistical Package forthe Socal Sciences (SPSS), version 24.0 (IBM Japan, Tokyo, Japan), was used forthe statistical analyses, All statistical tests were ‘ovotailed, and significance was determined atthe 0.05 level 3, Results 43.1. Enrollment and characteristics ofthe study population A total of 265 patients were included and randomized to receive ‘each treatment (Fg. 1). The number of monotherapy subjects was 114, ‘whereas the number of polypharmacy subjects (using two or more antipsychotic agents) was 148. The commonly prescribed ant Psychoties were risperidone (7 = 112), olanzapine (n= 61), levome- promazine (n = 60), and aripiprazole (n = 50). Table 1 describes the Daseline characteristics ofthe participants. As seen in Table 1, before the intervention, there were 1 significant differences between the ‘control and intervention group in demographic or clinical character istics. The proportion of participants meeting the HDL-C and BP criteria “ifered significantly by (ype of intervention group (supplementary lable SI), Prevalence of Mets did not difer among three groups at baseline, Table 2 provides the metabolic changes in each treatment ‘up. Group C showed a significant inerease in HDI-C, and decrease in ‘weight, BMI, waist circumference, and 7G. A significant increase in ‘mean HIbALc from baseline wae observed in group 8 3.2. Comparison beoven groups [As shown in Toble 5 differences berween groups were observed in ‘the ehanges in weight and BMI at 12 months. In completers, the change In weight dlifered significantly between groups, with subjects in group exhibiting greater decreases than those in group A or B, Similar re- salts were found when comparing BMI changes between groups, with subjects in group C exhibiting greater decreases than those in group A. ‘or B. Supplementary table S2 shows the results ofthe additional ana~ Iysis under the assumption of BOCF, Table 4 provides the prevalence of MetS and it criteria among the partiipants at 12-months. The prevalence of MetS based onthe ATP I AA definition differed significantly by type of intervention. When the ‘three groups were compared according to their percentage of weight loss (supplementary table $3, we found statistically significant dtfer- ‘ences. There seemed to be more patents in group C with reduction in body weight of 2786 and 25%. Juul of ae Research 97 201) 77-83 4. Diseussion ‘This randomized controlled study tested the efficacy of nutitonal selucation provided by a dietitian in reducing weight change and me- tabolic abnormalities among patients with schizophrenia who were bese during treatment with antipsychotic medications. After the 12- ‘month intervention, we found a signifcantly lower prevalence of Met in group C, Furthermore, we observed statistically significant decreases in mean weight and BMI in patents in group C but notin group A or B. ‘These findings indicate that monthly individual nutritional education sessions could improve weight gain and metabolic abnormalities in patients with schizophrenia. Several studies have aimed to mitigate antipsychoti-ascociated ‘weight gain and metabolic abnormalities in patients with schizophrenia (@apensstasiov, 2010). Although pharmacological interventions have resulted in clinically relevant weight loss (Mizuno eta, 2014), non- pharmacological interventions, such at behavioral and nutritional ‘therapy, could be the fies choice of intervention due tothe side effects of medications (Maayan e: =}, 2010), To date, several studies have ‘shown that non-pharmacologial interventions for weight reduction are more effective than control treatment (Caemmerer et al, 2012). Re- garding the preventive effect of non-pharmacologial interventions, Licell and colleagues examined the effects of a weekly nutritional education program provided by a master’s level clinician on weight gain induced by olanzapine (Lttll et al, 2003). After 4 months of treat ‘ment and an additional 2- month follow-up, the meas weight change in ‘the intervention group was ~0,06 Ibs, whereas the mean weight ‘change in the standard care group was 9.57 Ibs. Another study invo- ving 51 Australian psychiatric patients who received nutritional edu cation from a dietician every other week also showed a preventive ef fect of education on weight gain induced by olanzapine (Fvans et sl 2005). Specifially, after the $month treatment nd additional 3 month follow-up, the mean weight change in the intervention group was 2.0 kg, while the mean welght change in the standard eare group was 9.9 kp Inaudition co preventive effets, nor-pharmacological interventions Ihave been reported to be usefl for patients who ae already obese. A tal im Israel that included obese patients with schizophrenia showed that combined treatment including behavior therapy and nutritional education by a dietitian led toa significant reduction in weight among the intervention group after a3-month treatment and 1-year follow up (Qelamed et al, 2008). Another til in the US of obese patients with schizophrenia shoved that combined treatment including behavior therapy and nutritional education resulted ina significant difference in weight change between the control and intervention groupe after 18 months of treatment (Daumit et al, 2013). The authors of that study arabes ‘sup AG = 6) Groep nie = 67) rosy Cm = 60) acne Taman pole Baseline Taman pale Balin Tamewhe pean Washi) 92a? OaSH 9S 9S LAS oa La aiseay Tons fez oss oor tos T0013 oat. Spur imme) 1903 So 028s aks 172 ined tay oman Dhaest) 828 HI 08s 769108 Mo oa 7a FoLcimeidd 86 109 Se 097 483 ia os 0a Ghaow mga 1082 lea BIS) 0496 ose ato Se oss asa Boateco 5408 room «$5 oa Ses oom Ss * raed apie ts ads asides, SP = Spi Heed prune, Da? = Dialed reer HD Jaa of ae Research 97201) 77-83 Wert 0s dO awake oe as ~

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