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A pilot study of a weight management program with food provision in schizophrenia

A pilot study of a weight management program with food provision in schizophrenia
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  A pilot study of a weight management programwith food provision in schizophrenia Michel Jean-Baptiste, Cenk Tek  ⁎ , Ellen Liskov, Umesh Rao Chakunta,Sarah Nicholls, Akm Q. Hassan, Kelly D. Brownell, Bruce E. Wexler   Department of Psychiatry, Yale University School of Medicine, New Haven, CT, United States Received 23 February 2007; received in revised form 14 May 2007; accepted 16 May 2007Available online 12 July 2007 Abstract Obesity is a serious medical problem that disproportionately affects people with severe mental illness. Behavioral strategiesaimed at lifestyle modification have proven effective for weight loss in general population but have not been studied adequatelyamong persons with schizophrenia. We have conducted a randomized controlled pilot trial of an established weight loss program,modified for this specific population, and supplemented with a novel food replacement program, as well as practical, community based teaching of shopping and preparing healthy food. The program not only arrested weight gain, and produced meaningfulweight loss, but also weight loss continued 6 months after the intervention is completed. Cognitive impairment had no bearing tothe extent a participant benefited from the program. As a conclusion, well designed simple behavioral programs can produce lastingweight loss for patients with schizophrenia and comorbid obesity, improve metabolic indices, and possibly decrease significant medical risks associated with obesity.© 2007 Published by Elsevier B.V.  Keywords:  Schizophrenia; Schizoaffective disorder; Obesity; Behavioral intervention Obesity is one of the most important public health problems in the United States increasing the risk for multiple illnesses (Pi-Sunyer, 1993; Hedley et al., 1999).Disproportionate number of people with severe mentalillness suffers from morbid obesity (Allison et al., 1999a).Persons with schizophrenia die earlier with two to threetimes the mortality rate of the general population possibly because of high rates of obesity, cardiovascular disease,diabetesmellitus,andthemetabolicsyndromeobservedinthis population (Goff et al., 2005; Keck and McElroy,2003). In addition to the weight gain associated with psychiatric medications, sedentary life style, lack of availability of healthy food options for this mostlyeconomically deprived patient population, as well asinadequate knowledge or understanding of health main-tenance issues appear to contribute to the increased rate of obesity among patients with schizophrenia.Prevalence ofobesityandensuingmetabolic syndromeinthepopulationofpatientswithseverementalillnesswasfound to be much higher than the general population(Allison et al., 1999b; McEvoy et al., 2005; Saari et al.,2005). Antipsychotic medications have been associatedwith weight gain since their introduction in the 1950's(Allison et al., 1999c). In the past several years, atypical Schizophrenia Research 96 (2007) 198 – ⁎ Corresponding author. 34 Park St., Rm.267E, New Haven, CT06525, USA. Tel.: +1 203 9747484.  E-mail address: (C. Tek).0920-9964/$ - see front matter © 2007 Published by Elsevier B.V.doi:10.1016/j.schres.2007.05.022  Table 1Overview of prospective behavioral weight management studies for psychotic outpatientsAuthors Patient population Design  N   (mean entry BMI) Intervention Average weight change in lb SignificanceIntervention ControlBall et al. (2001) Patients with schizophrenia, and whogained more than 7% body weight while on olanzapine. Nonrandomized,intervention groupvolunteered for program,control group usual care,matched on criteria11 intervention (32),11 control (25)10-week commercial weight watchers program, andstructured exercise. − 5.1  − 0.5 NSVreeland et al. (2003) Patients with schizophrenia or schizoaffective disorder, onatypical antipsychotics, and who had aBMI over 26 or gained more than five pounds after the medication is started Nonrandomized,Intervention groupvolunteered for program,control group usual care,matched on criteria31 intervention (34),15 control (33)Multimodal weight control program,12 weeks, 25 sessions − 6.0 +6.3 Sig.Menza et al. (2004) Same study as above Same study as above 31 intervention,20 completed (34),20 control (33)Above interventioncompleted to 52 weeks. − 6.6 +7.0 Sig.Littrell et al. (2003) Patients with schizophrenia or schizoaffective disorder, onconventional antipsychoticsRandomizedcontrolled study22 intervention (26),21 control (27)16-week psychoeducationon nutrition,exercise, lifestyle − 0.6 +9.6 Sig.Kalarchian et al. (2005) Patients with psychosis, takingatypical antipsychotics and has aBMI of 30 or greater Open study 29 (36) 3 months stop light diet   − 5.0 NA SigBrar et al. (2005) Patients with schizophrenia or schizoaffective disorder, Who areswitched from olanzapine to risperidone,and who had a BMI over 26Randomized,controlled,rater blinded34 intervention,37 controls (meanBMI not available)Behavioral treatment teaching weight lossstrategies, 14 weeks − 4.4  − 2.4 NSEvans et al. (2005) Mixed diagnosis, patients Randomizedcontrolled study29 intervention (27),22 control (29), Over 60% dropout  by study end Nutritioneducation, 6 sessions+4.4 +21.8 SigWeber and Wyne (2006) Patients with schizophrenia or schizoaffective disorder, onatypical antipsychoticsRandomizedcontrolled study8 intervention (33),7 control (33)CBT, 16 weeklysessions − 5.9  − 1.8 NSSoo Kwon et al. (2006) Korean patients with schizophrenia or schizoaffective disorder, who gainedmore than 7% body weight whileon olanzapine.Randomizedcontrolled study33 intervention (27),15 control (28)12 week CBT andexercise − 8.7  − 3.3 SigCentorrino et al. (2006) Patients with schizophrenia or schizoaffective disorder, a weight gainof 4.5 kg and an increase in BMI of 5%since starting antipsychotic treatment Open trial 17 intervention (37) 24 week intensive,24 week less intensivenutritional counseling,exercise, and lowfat/low calorie diet. − 13.2 first 24 weeks(0.48 lb weight gainfrom wk24 to 48 inthe second phase) NA 1   9   9   M . J   e a n-B  a  p t   i   s  t   e e t   a l    . /    S  c h  i  z  o  p h r  e n i   aR  e s  e ar  c h  9  6   (  2  0  0  7   )  1  9  8  – 2  0  5   antipsychotic-induced weight gain has become a major health concern in patients with schizophrenia or schizoaf-fective disorder (Spivak et al., 1999). A recent study of theeffectiveness of antipsychotic drugs (CATIE) found that overan18-monthperiodconsiderableweightgain( N 7%of  baseline weight) occurred in 30% of olanzapine recipientsand7%to16%ofpatientsonotherdrugs(Liebermanetal.,2005). In a large schizophrenia first episode study, patientsgained an average of 16 kg on olanzapine, and 7.5 kg onhaloperidol; with BMI increases of 4.7 and 2.7 kg/m 2 over a course of two years (Zipursky et al., 2005). Treatments aimedatlifestyle modificationhave proveneffective in producing weight loss in general population(Brownell, 1998, 1999; Foreyt, 2005). Specifically, themodificationofeatingbehavior,ofphysicalactivity,andof  psychologicalfactorssuchasattitudes,goalsandemotionscontributes to weight loss and maintenance of the lost weight(Brownell,1999,2004).Caloricrestrictionremainstheprincipalmeansofachievingweightlossinoverweight andobese individuals. Several approaches have been usedto promote weight loss: behavior therapy, self-help books,commercial and self-help programs, internet-based pro-grams, pharmacotherapy and surgery. It is generally ac-cepted that lifestyle change is necessary, no matter what approach is used for weight control.Despiteofthemagnitudeoftheobesityproblemanditsconsequences in persons with schizophrenia, only limitedresearch exists on how to effectively tackle this problem.Anoverviewofthepublishedclinicaltrialsofmanagement of obesity in patients with severe mental illness is pre-sentedinTable1.Overall,thereisapaucityofrandomizedcontrolledtrials(RCT).However,regardlessofthemethodused, most studies managed to arrest the weight gain, and/ or provided modest benefits, as cumulatively presented inTable 2.Obesityandits related medical conditions contribute toincreasedmortalityrateamongpersonswithschizophreniaandtoincreasedhealthcarecosts.Despitethemagnitudeof the problem, research on obesity interventions for personswith schizophrenia is relatively neglected and there is notreatment that has convincingly shown to be effective for weightreductioninthispopulationwithuniqueneeds.Our study explored the feasibility and effectiveness of a wellestablished and effective weight management program for the general population, The LEARN Program for Weight Management (Brownell, 2004). We have modified theLEARN program for the special needs of this populationand coupled it with an innovative food provision programto arrest weight gain, produce weight loss, improvemetabolicmarkers,andproducedurablechangeinlifestyleamong severe mentally ill patients. 1. Methods This is a randomized controlled trial of weight management for obese patients with schizophrenia or schizoaffective disorder.Thestudyprotocol wasapproved bytheHumanInvestigationCommitteeofYaleUniversitySchool of Medicine. 1.1. Subjects Eighteen adult patients with DSM-IV diagnosis of schizophrenia or schizoaffective disorder followed in theoutpatient clinics at the Connecticut Mental Health Center who were treated by antipsychotic medications, with a body mass index (BMI) of   N 30 kg/m2 were enrolled andrandomized to either group A or group B. Patients withdiabetes mellitus patients who had a change in antipsy-chotic medication agent or dose within the previous threemonths were excluded from the study. 1.2. Procedure Group A (8 patients) received the behavioral interven-tion consisting of weekly group sessions with a registereddietitian and a psychiatrist. At the end of the intervention,group Awas crossed over to no intervention and group B(10 patients) received the intervention. Group B served ascontrol for Group A and received treatment as usual whilewaiting.Body weight and blood pressure were measured week-ly for 16 weeks and monthly for 6 months after the inter-vention was completed. The same scale and electronic Table 2Summary of prospective behavioral weight management studies for psychotic outpatientsIntervention  N   Intervention BMI(weighted average)Control  N   Control BMI(weighted average)Intervention weight change(weighted average, lb)Intervention weight change(weighted average, lb)Randomizedstudies126 27.3 102 28.6  − 2.9 +5.2All publishedstudies214 31.05 128 28.85  − 4.5 +4.8200  M. Jean-Baptiste et al. / Schizophrenia Research 96 (2007) 198  –  205  equipment for measuring vital signs were used andregularly calibrated throughout the study. Serum fastingglucose, cholesterol, and triglycerides were measured at  baseline, at the end of the intervention, and at 6 monthsafter the intervention was completed. All subjects wereadministered the California Verbal Learning Test (CVLT,Delis et al., 1987) as a general measure of cognitive andlearning ability. 1.3. Intervention1.3.1. LEARN behavioral modification Participants attended meetings 45 to 60 min in length,weekly for a total of 16 weeks. Nutrition education pro-videdforthisprogramwasbasedupontheprinciplesoftheUSDA'sFoodGuidePyramid.The behavior modification portion of the weekly sessions was designed using principles based on the LEARN Program. Each week, anutrition education topic was discussed such as optimalfood choices for weight loss, portion control, dining out,healthy cooking skills, reading labels, and healthy snacks.Behavior modification strategies were taught to assist par-ticipants with making permanent lifestyle changes. Topicssuch as goal setting, record keeping, cue elimination,overcoming non-hunger related eating, and motivationwere integrated into each session. Time was allowed for discussion, group support and questions at each session. 1.4. Physical activity enhancement  Exercise was encouraged and pedometers for countingsteps were provided to participants to track their level of activity.Twogroupwalkswereconductedduringeach16-week intervention. 1.5. Food provision At the first meeting, participants were provided with aspecific listing of foods they could purchase that theywouldbereimbursedfor,uptotwenty-fivedollarsaweek.At the start of each weekly class thereafter, the dietitianreviewed each participant's receipt and determined whichitems were reimbursable as per the original list of allowable items. This was also an opportunity for thedietitian to provide personalized feedback and counselingtoeachparticipantregardingfoodchoices.Thepurchaseof fruits, vegetables, lower fat dairy products, whole grain breads and cereal that were low in sugar content, and leancuts of meat and poultry were considered reimbursablefoods. Snack foods and desserts were not deemed asreimbursable, even for low fat versions. The reimbursablefood list was constructed to allow for participants to pur-chasemorefruits,vegetables,wholegrainsandleanercutsof meat which may have otherwise been too costly in this population. The weekly reimbursement of up to twenty-five dollars was an indirect method of food provision andat the same time served as a financial incentive for attendance. 1.6. Individually tailored nutrition support  Participantswereencouragedtokeepafoodrecordandsubmit it weekly to the dietitian. When completed by a participant, each record was reviewed by the dietitian,counseling was done regarding food purchases, andindividualized feedback was provided. 1.7. Grocery store visit and cooking demonstration A grocery store tour was led by the dietitian on week 3to provide on site education about how to navigate acluttered supermarket, review label reading and identifyhealthier food purchases. A demonstration on preparinghealthy recipes was performed once for each interventiongroup. 1.8. Statistical analysest  -tests were used to compare the weight change for completers during the 16-week active intervention in theexperimental group ( n =8) and the weight change over thesame 16-week period for the waiting list control group( n =9). The completers in two groups were thencombined( n =14) to evaluate the intervention effects of the activeintervention at week 16 in a larger sample. For all thosewho completed the 6-month follow-up( n =12),a repeatedANOVAwas used to evaluate the maintenance of weight lossuptothe 6-monthfollow-up.Post-hoc tests comparedweights at baseline and the end of the 16-week intervention, at week 16 and 6-month follow-up, and at  baseline and 6 months. Association of CVLT total scoreand outcome measures were explored. Table 3Demographic characteristicsGroup A Group B Both groupsSample size 9 9 18Completers/dropouts 8/1 6/3 14/4Gender M=2; F=7 M=7; F=2 M=9; F=9Race (Caucasian/AfricanAmerican)C=5; AA=4 C=6; AA=3 C=11; AA=7Age (Mean years) 52.37 40.73 47.29Schizophrenia 4 6 10Schizoaffective disorder 5 3 8201  M. Jean-Baptiste et al. / Schizophrenia Research 96 (2007) 198  –  205  2. Results The demographic distribution of the participants is presented in Table 3. The following medications wereused by the participants either singly or in combination:Clozapine ( n =7); Olanzapine ( n =7); Risperidone( n =4); Haloperidol ( n =2); Perphenazine ( n =2);Thiothixene ( n =1); Fluphenazine ( n =1); Quetiapine( n =1); Ziprasidone ( n =1).14 patients completed the intervention phase of thestudy. Most of the dropouts were from the waitlist group.One subject was lost to follow-up after the initial assess-ment, two subjects completed the waitlist period assess-ments but did not start the intervention phase, and onesubject was hospitalized after the twelfth week waitlist assessmentandremainedinhospitalwhentheintervention phasestartedherlastobservationwascarriedforward,after medical record review confirmed no weight change oneweek after the scheduled waitlist end assessment.We found a significant weight loss during the activeinterventionforthefirstinterventiongroupascomparedtothe waitlist control group ( t  =2.47,  p =026), with meanweightlossof6.4lbforinterventiongroupascomparedto5.9 lb weight gain in the waitlist control group during thesame 16 weeks. Once the control group had received the16-week active intervention, the data for the active inter-vention in both groups' data were combined. Weight change in both groups were similar (6.4 lb vs. 5.7 lb, t  =1.38, NS). Paired  t  -tests indicated a significant weight loss for the larger sample (paired  t  =2.54,  p =.025), withmean weight at week 1=227.82, SD=36.59 and meanweight at week 16=221.71, SD=40.18. For all subjectswho completed the 6-month follow-up ( n =12) repeatedANOVA showed a significant main effect for time [  F   (2,22)=4.67,  p b .02]andasignificantlineartrend[  F  (1,11)=6.43,  p b .03], indicating that the weight loss happenedsteadily over time and continued during the post treatment follow-up (Fig. 1). Mean weight declined from week 1(mean=225.33, SD=35.81) to week 16 (mean=218.92,SD=38.36) to 6-months (mean=214.92, SD=38.49).Paired  t  -tests showed significant differences in weight  betweenweek1andweek16(paired t  =2.54,  p =.025),and between week 1 and 6-month follow-up (paired  t  =2.54,  p =.028),butnotbetweenweek16and6-monthfollow-up.For those subjects who lost weight, repeated ANOVAsfor the blood-related variables showed a significant maineffect for time in fasting blood glucose  F  (2,8)=6.29,  p b .02andatrendtowardasignificantmaineffectfortimein triglycerides  F  (2,8)=3.81,  p b .07. Mean fasting bloodglucose declined from week 1 (mean=102.80, SD=5.45)to week 16 (mean=90.20, SD=11.63) and rose slightly at 6-monthfollow-up(mean=92.80,SD=9.31,Fig.2.Meantriglycerides decreased from week 1 (mean=273.80,SD=131.85) to week 16 (mean=268.40, SD=115.97) to6 month follow-up ( mean=220.40, SD=155.13).CVLT total score (mean 40.29, SD=9.97) was not correlated with weight change ( r  = − 0.134, NS) or serum parameters. There was no significant difference betweentheCVLTtotalscoreofsubjectswholostorgainedweight at 16 weeks or 6 months. 3. Discussion The results of this pilot study demonstrate that it is possible for patients with severe mental illness to loseweight while taking antipsychotic medications, regardlessof the level of cognitive functioning. The magnitude of weight loss at the end of the 16-week intervention period(mean6.41lb)iscommensuratewithothersimilarstudies.However, the mean weight loss at 6 months of 10.41 lbexceeds most previous studies and was achieved without  booster sessions. Fig. 1. Average weight at baseline, week 16, and 6-month follow-up.202  M. Jean-Baptiste et al. / Schizophrenia Research 96 (2007) 198  –  205
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