university of groningen lifestyle interventions in

University of Groningen

Lifestyle interventions in patients with a severe mental illnessLooijmans, Anne

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Changing the obesogenic environment to improve cardiometabolic health in residential patients with a severe mental illness: cluster randomized controlled trial

Anne Looijmans, Annemarie P.M. Stiekema, Richard Bruggeman, Lisette van der Meer, Ronald P. Stolk, Robert A. Schoevers, Frederike Jörg* & Eva Corpeleijn** Equal contribution as senior authors

The British Journal of Psychiatry, 2017; 211(4)

Chapter 3

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Chapter 3

ABSTRACT

Background:Forpatientswithseverementalillness(SMI)inresidentialfacilities,adoptingahealthylifestyleishamperedbytheobesitypromoting(obesogenic)environment.

Aims: To determine the effectiveness of a 12-month lifestyle intervention addressingtheobesogenicenvironmentwithrespecttodietandphysicalactivitytoimprovewaistcircumferenceandcardiometabolicriskfactorsversuscare-as-usual(DutchTrialRegistry:NTR2720).

Method: In a multi-site cluster-randomized controlled pragmatic trial, 29 care teamswererandomizedinto15intervention(365patients)and14controlteams(371patients).Interventionstaffweretrainedtoimprovetheobesogenicenvironment.

Results: Waistcircumferencedecreased1.51cm(95%CI=-2.99;-0.04) in interventionversuscontrolgroupafter3monthsandmetabolicsyndromeZ-scoredecreased0.22s.d.(95%CI = -0.38; -0.06). After 12months, the decrease inwaist circumferencewas nolongerstatisticallysignificantlydifferent(-1.28cm;95%CI=-2.79;0.23,p=0.097).

Conclusions:TargetingtheobesogenicenvironmentofresidentialpatientswithSMIhasthepotentialtofacilitatereductionofabdominaladiposityandcardiometabolicrisk,butmaintaininginitialreductionsoverthelongertermremainschallenging.

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ELIPS – somatic outcom

es

INTRODUCTION

Patientswithaseverementalillness(SMI),mostlyschizophrenia,otherpsychoticdisorders,majordepressionorbipolardisorder,havealmost twice thenormal riskofprematuredeathfromcardiovasculardisease1,aremorelikelytosufferfromthemetabolicsyndrome(MS)2,andhaveanup to30years shortened lifeexpectancycompared to thegeneralpopulation3.Theincreasedmortalityriskisassociatedwithsideeffectsofantipsychoticmedicationaswellasunhealthybutmodifiablelifestylebehaviors4. LifestyleinterventionsinSMIpatientshavepreviouslybeenshowntoreducebodyweight5 andwaist circumference, and to improve cardiometabolic risk factors such asserum triglyceride levels, fasting glucose and insulin concentrations6,7. These studiesincludedmostlyoutpatients8,9orfirstepisodepatientswith schizophrenia10,11,whereasstudies in SMI patients admitted to sheltered or clinical care facilities are scarce. Inaddition,sustainabilityofeffectsisquestionable. Mostlifestyleinterventionsaredesignedtostimulateindividualstochangetheirdietandphysicalactivitybehaviorandinvolvecounseling,goalsettingandweightmonitoring.The challenge of these programs is that they highly depend on individual patients’interests,motivationandcapacities,whicharereducedinSMIpatientsduetonegativesymptomsandcognitivedeficits12.Inresidentialfacilities,thesettingisimportantaswellsincefacilitiesareoftencharacterizedbyan‘obesogenic’environmentduetoabundantprovisionofunhealthyfoodproductsandalackofdailyactivities13,14.Theapproachtofocusontheobesogenicenvironment,‘makingthehealthychoicetheeasychoice’byeducatingstaffhowtochangedailypracticewithregardtohealthynutritionandphysicalactivitiesinthefacility,mayleadtosustainablechangesforallresidentialSMIpatients.TwostudiesaddressedtheobesogenicenvironmentofSMIresidentialpatientsbymodifyingthefooddelivery15oradjustingtheofferedfoodcombinedwithnutritionalcounselingandexercisesessions16,andreportedpromisingimprovementsinpatients’somatichealth.However,thesestudieslackedacontrolgroup15orhadasmallsamplesize16.AnotherapproachthatmayworkwellfortheSMIpopulationisthe‘smallchangeapproach’.Thisapproachaimsformodestlifestylechangesleadingtomodest,butsustainableweightlossinthelong-term17. We developed the Effectiveness of Lifestyle Interventions in PSychiatry (ELIPS)trial18.Inthistrial,wedesignedalifestyleinterventiontoimprovecardiometabolichealthof SMIpatients living in residential facilitiesby stimulatingahealthy lifestylevia smallbut sustainable changes in theobesogenicenvironment. TheELIPS trial is apragmaticrandomizedcontrolledtrial(RCT),designedtooffertailored,scalableandimplementableinterventions19.Thismeansthatalready in thetrialphase, the interventionwasaimedat and implemented by regular staff members in daily care. We expected stable orimproved cardiometabolic health in the intervention group compared to deterioratedcardiometabolic health in the control group. In addition, we explored whether theinterventioneffectdependsongender,ageandtypeoffacility.

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Chapter 3

METHODS

TheELIPSstudyprotocolwaspublished18andwillbeshortlyexplainedbelow.TheMedicalEthical Committee for Research inMental Health Care (Metigg) concluded that studyprotocolanduseofanonymizeddatafromRoutineOutcomeMonitoring(ROM;below)was inaccordancewiththeDeclarationofHelsinkiand(inter)national regulations,andthat the study did not fall under the scope of theMedical Research InvolvingHumanSubjectsAct,therebywaivinginformedconsent.ThetrialwasregisteredintheDutchTrialRegistry(NTR2720,www.trialregister.nl).

Participants and recruitmentSMIpatientsfromallshelteredandlong-termclinicalcareteams(n=29teams,20-65patientsperteam)oftwomentalhealthorganizationsintheNetherlandswereincludedinthestudyfromSeptember2010untilDecember2011iftheyparticipatedintheannualROM(below)(Figure 1). Long-term clinical care facilities deliver direct, all-day intensive professionalcare.Shelteredfacilitiesprovidesupportedliving,acombinationofhousingandservicesinthecommunity.Exclusioncriteriawereagebelow18,pregnancy,Korsakovsyndromeorinabilitytoparticipateintests.Intotal240patientsperarmwereneededtodetectaclinicalrelevantchangeof-5%inwaistcircumference(alpha=0.05,power0.90),takingintoaccountanestimated10%dropoutbasedonthefactthatmeasurementswerepartofroutineoutcomemonitoringscreeningsperformedinawell-establishedinfrastructure.

InterventionThe ELIPS intervention was directed at nursing teams and addressed the obesogenicenvironment of patients; see ELIPS study protocol18 for examples from practice. Theintervention consistedof a preparation, implementationandmonitoringphase. In theone-month preparation phase, lifestyle coaches introduced themselves to staff andpatients, screened the environment and teams’ daily routines, and listed patients’and teams’ preferences and sites’ logistic possibilities. Lifestyle coaches created ateam-tailored lifestyle plan based on listed preferences and possibilities and four pre-establishedELIPSlifestylegoals:(a)tostimulatephysicalactivity;(b)toincreasesupply/availabilityofhealthyfoodproducts;(c)toorganizeatleastoneactivityperweekfocusedonahealthydietand(d)toimprovetheobesogenicenvironmentonorganizationallevel.Inthe3-monthsimplementationphase,lifestylecoachesimplementedtheplannedELIPSlifestyleactivitiesasdescribed intheteam-tailored lifestyleplan.Lifestylecoachesfirstdemonstrated activities to staff, then carriedout the activities togetherwith staffandfinally supervised staff while they carried out the activities. Lifestyle coaches trainedteamstocreateahealthyenvironmentandstimulatehealthybehaviorsinpatients.Attheendoftheimplementationphase,teamssetgoalstoachieveinthe9-monthsmonitoringphase.Inthemonitoringphase,alifestylecoachvisitedallinterventionteamstwiceand

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discussedwiththeteamandteamleaderwhethergoalswereachieved,whichbarriersinachievingthegoalswereencounteredanddiscussedoptionstotacklethesebarriers.Also,theresearchersorganizedonebenchmarkmeetingforallinterventionteamleaderswheredifficultiesinachievingteamgoalswerediscussedandtips,tricksandsuccessfulexampleswereshared.LifestylecoachesweretrainedfortwodaysontheELIPSlifestyleprogram,motivational interviewingtechniquesandonthepatientpopulation.Lifestylecoacheswerefulfillingthefinaloffouryearsofeducationtobecomeprofessionallifestylecoaches. Because lifestyle coaches were still in training, each team had two lifestylecoachesat itsdisposal,whowereappointedby the research team.Perweek, lifestylecoachesspentonaverage8hoursonactivitieswithpatients(6contacthoursandabout2hourpreparationtime)and8hoursontrainingofstaffandorganizationalaspects,likedevelopinginformationmaterials,meetingswithstaff,andprojectmanagement.

30 Teams agreed to

participate 1 Team excluded: exclusively served

patients suffering from Korsakov’s syndrome29 Teams clustered in

13 clusters of 2 or 5 teams

Intervention arm: 15 teams; 400 patients

Control arm: 14 teams; 414 patients

Baseline measures: 400 patients;

vcd for 329 patients

Start intervention: 3-month

implementation phaseCare as usual

3-month follow-up:vcd for 318 patients


Care as usual9-months monitoring phase



1-month preparation phase

Included in analysis: 344 patients with at

least one somaticmeasure











In final analysis forprimary outcome:

316 patients

In final analysis forprimary outcome:

320 patients

Randomization per cluster

Baseline measures: 414 patients;

vcd for 352 patients

Legend:vcd = valid care data

Figure 1. FlowchartofpatientsintheELIPStrial.Atotalof736patientshaveatleastonephysicalmeasureatbaselineor12-monthsfollow-upandwereincludedintheanalysis(notretraceableinflowchart).

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Chapter 3

Patientsinthecontrolconditionreceivedcareasusual.Lifestyleinitiativesincontrolteamsweredocumented.Randomizationwasperformedatteamlevelusingarandomizedblockdesignwith12clustersoftwocomparableteamsandoneclusteroffivecomparableteamsbasedonmentalhealthcareorganization,typeoffacility,caseloadsizeandlocation(urbanorrural).Teamswererandomizedfifty-fiftyintointerventionorcontrolarmwithcomputerizedrandomnumbergeneratorbyanon-participatingresearchnurse.

Measurements and outcomesPrimary outcome was waist circumference (WC) at three and twelve months afterbaseline. Secondary outcomes were Body Mass Index (BMI; kg/m2) and metabolicsyndromeZ-score.Informationonage,gender,diagnosisandmedicationusewasderivedfrompatientrecords.PhysicalhealthdatawerecollectedbytrainednursesinannualROMscreenings,partoftheongoingPHAMOUS(PharmacotherapyOutcomeandMonitoringSurvey) cohort20. AnnualROMscreeningsare standardcare inbothorganizationsandwererescheduledone/twoweeksbeforestartoftheintervention(baselinemeasure)andthreeandtwelvemonthsthereafter(follow-upmeasurements).Patientsreceivedasmallfeefortheadditional3-monthsROMscreening(€5.00/$5.38).ROMnurseswereblindedtointerventionallocation.WCwasmeasuredtwiceinstandingpositionattheendofanexpirationusingaflexiblenon-stretchingtapehalfwaybetweeniliaccrestandlowestrib.Weightwasmeasuredbycalibratedscales(Seca,model813,Hamburg,Germany)inlightclothingwithoutshoesorjackets.Heightwasmeasuredwithoutshoes.Systolicanddiastolicbloodpressure(BP)weremeasuredusinganautomatedbloodpressuremonitor(BOSOmedicuscontrol,Jungingen,Germany)insittingpositionafterfiveminutesrest.Patientsvisiteda(hospital) laboratorytocollectafastingbloodsampleforlevelsof lipids(totalcholesterol,LDL-cholesterol,HDL-cholesterolandtriglycerides)andglucosemetabolism(glucose,HbA1c). Ifnot fasting, thiswas routinely indicatedon the formby thenurse. The metabolic syndrome was defined as the presence of three or more of thefollowingcriteria21:(a)waistcircumference≥88/102cm(female/male);(b)systolicBP≥130and/ordiastolicBP≥85mmHgorreceivingantihypertensivemedication;(c)HDL-C<1.03/1.3mmol/L(female/male;divideby0.0259toconverttomg/dL)orreceivinglipid-loweringmedication;(d)triglycerides≥1.7mmol/L(divideby0.0113toconverttomg/dL)orreceiving lipid-loweringmedication;and(e)fastingglucose≥6.1mmol/L(divideby0.0555 to convert tomg/dL)22, receivingantihyperglycemicmedicationor reportingadiagnosisfordiabetes.Whenfastingglucoselevelswerenotavailable(baseline:46%,n=342; 3-months: 53%, n=392; 12-months: 46%, n=342), patients were considered tofulfilltheglucoseriskcriterioniftheyreportedtohavediabetes(9.6%,n=71)orifHbA1c≥6.0%23.TheindividualcomponentswerestandardizedintoZ-scores(withHDL-cholesterolZ-scoremultipliedby-1)24,25andthesumdividedbyfivewasusedasacontinuousvariablefor the degree ofmetabolic syndrome (MS Z-score). BPwas standardized usingmeanarterialpressure(MAP).

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Antipsychotic medication (AP) was categorized in three groups according to thestrengthof the sideeffectoncardiometabolichealth (none,mild,or strong)basedonliterature(seeSupplementary Table 1)26,27.

Statistical analysesDatawereanalyzedaccordingtotheintention-to-treatprincipleusingSPSSversion22.Ap-value<.05wasconsideredstatisticallysignificant.Resultsarereportedasmean(95%confidenceinterval).DifferencesinfrequencydistributionsweretestedwithChi-squareorMannWhitneyUtests.Fortestingmaindifferencesbetweeninterventionandcontrol,alikelihood-basedgenerallinearmixedmodelwasapplied,usingasubject-specificmodeltoadjustforclusteringofpatientswithinteamsusingan‘unstructured’errorstructure,andcontrollingfortheblockdesign.Forallanalyses,theoutcomesovertimeperpatientformed the first level of the model, the patient formed the second level, and teamformedthethirdlevelandclusterasrandomfactor.Sinceitispossiblethatinterventioneffects on somatic outcomes differ between implementation (first threemonths) andmonitoring phase (ninemonths thereafter), timewas coded as twodummy variables.Group(interventionorcontrol),time,andgroupbytimeinteractionswereenteredinthemodelasfixedfactorswithadjustmentforage,gender,typeoffacilityandAPmedication.Asasecondaryanalysis,clinicallyrelevantchangewasstudied,definedasachangeofatleast5%WC.Finally,westudiedthe interventioneffectwithinpre-specifiedsubgroups(gender,agegroupsandtypeoffacility).

RESULTS

The29teamswererandomizedinto14controland15interventionteams,resultingin814eligiblepatients(Figure 1).Ofthese,736(90%)hadatleastonephysicalmeasurementatbaselineorat12monthsandwereincludedintheanalyses.Themajorityofpatientsweremale(63.2%),themeanagewas48.3(s.d.=12.6)yearsrangingfrom20to85years(Table 1).

Table 1. Baseline characteristics of participants in the Effectiveness of Lifestyle Interventions inPSychiatry(ELIPS)study.

N Total Intervention group

Control group p

Teams,n 29 15 14

Patients,n 736 365 371

Age,years:mean(s.d.) 736 48.3(12.6) 49.3(12.0) 47.2(13.2) 0.03

Malegender,n(%) 736 465(63.2) 236(64.7) 229(61.7) 0.41

Housing,n 736

Shelteredliving,teams(patients) 18(434) 9(196) 9(238) 0.004

Long-termclinicalfacilities,teams,(patients) 11(302) 6(169) 5(133)

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Chapter 3

Table 2. BaselineclinicalcharacteristicsofparticipantsintheEffectivenessofLifestyleInterventionsinPSychiatry(ELIPS)studya.


Control group p

Body composition

Metabolicsyndrome,n(%) 387 226(58.4) 120(58.5) 106(58.2) 0.95

MetabolicsyndromeZ-score,mean(s.d.)b 387 0.45(1.02) 0.48(1.05) 0.42(0.98) 0.59

BodyMassIndex(BMI),kg/m2:mean(s.d.) 616 28.0(6.3) 27.8(6.3) 28.3(6.2) 0.27

BMIcategories,n(%): 0.34

Normal(BMI<25) 210(34.1) 108(36.6) 102(31.8)

Overweight(BMI25-29) 210(34.1) 100(33.9) 110(34.3)

ObeseI(BMI30-34) 117(19.0) 48(16.3) 69(21.5)

ObeseII(BMI35-39) 50(8.1) 27(9.2) 23(7.2)

ObeseIII(BMI≥40) 29(4.7) 12(4.1) 17(5.3)

Waistcircumference,cm:mean(s.d.)

Men 350 104.4(16.1) 105.6(15.4) 103.1(16.8) 0.14

Women 208 103.0(17.0) 104.0(18.7) 102.2(15.5) 0.45

Bloodpressure(BP),mmHG:mean(s.d.) 612

SystolicBP 129.8(18.8) 129.9(19.3) 129.8(18.3) 0.97

DiastolicBP 84.2(12.1) 84.6(12.8) 83.8(11.4) 0.43

UseofBP-loweringmedication,n(%) 646 137(21.2) 79(25.2) 58(17.5) 0.02

Lipids

Totalcholesterol,mmol/L:mean(s.d.) 477 5.19(1.13) 5.10(1.16) 5.29(1.08) 0.07

HDL-cholesterol,mmol/L:mean(s.d.)

Men 293 1.10(0.33) 1.08(0.32) 1.12(0.33) 0.38

Women 182 1.33(0.41) 1.38(0.39) 1.27(0.43) 0.06

LDL-cholesterol,mmol/L:mean(s.d.) 461 3.19(1.01) 3.07(1.02) 3.33(0.98) 0.005

Triglycerides,mmol/L:median(25-75th percentile) 475 1.67(1.12-2.42) 1.65(1.08-2.35) 1.69(1.14-2.50) 0.58

Useoflipidloweringmedication,n(%) 646 114(17.6) 64(20.4) 50(15.1) 0.08

Glucose metabolism

Fastingglucose, mmol/L:median(25-75thpercentile) 394 5.60(5.10-6.40) 5.60(5.20-6.30) 5.60(5.08-6.40) 0.34

HbA1c,%:median(25-75thpercentile) 301 5.60(5.25-6.00) 5.70(5.30-6.00) 5.50(5.10-5.90) 0.003

Useofglucose-loweringmedication,n(%) 646 104(16.1) 51(16.2) 53(16.0) 0.92

Psychiatric characteristics 736

Psychiatricdiagnosis,n(%)

Psychoticdisorder 534(72.6) 277(75.9) 257(69.3) 0.04

Mood disorder 76(10.3) 37(10.1) 39(10.5) 0.87

Personality disorder 238(32.3) 105(28.8) 133(35.8) 0.04

Psychiatriccomorbidity,n(%)c 179(24.3) 79(21.6) 100(27.0) 0.09

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Table 2. BaselineclinicalcharacteristicsofparticipantsintheEffectivenessofLifestyleInterventionsinPSychiatry(ELIPS)studya (continued).


Control group p

Useofantipsychotics,n(%) 646 581(89.9) 288(91.7) 293(88.3) 0.14

Antipsychoticmetabolicsideeffect,n(%) 581 0.77

None 57(9.8) 30(10.4) 27(9.2)

Mild 197(33.9) 100(34.7) 97(33.1)

Strong 327(56.3) 158(54.9) 169(57.7)

aSIunit conversion factors: to convert total cholesterol,high-density lipoprotein (HDL)-cholesteroland low-densitylipoprotein(LDL)-cholesteroltomg/dL,dividevaluesby0.0259;toconverttriglyceridestomg/dL,dividevaluesby0.0113;toconvertfastingglucosetomg/dL,dividevaluesby0.0555.b Themeans and standarddeviationsof thepatients rangingwithin healthy reference valueswereused tostandardizeHDL-C(1.1-2.0mmol/L in womenand0.9-1.7mmol/L inmen),triglycerides(≤2.2mmol/L)andfastingglucose(≤7.1mmol/L)orhaemoglobinA1c(HbA1c)(<8.0%).cTwoormoreofthedefineddiagnoses.

Most patientswere overweight or obese (65.9%) and 58.4%met the criteria formetabolic syndrome (Table 2). In the intervention group, 46%of the patients lived inlong-termclinicalfacilitiescomparedto36%inthecontrolgroup(p<.01).Thisyieldedasignificantlyhigherageandmorepsychoticdisordersintheinterventiongroup. After three months of lifestyle intervention, the intervention group showed asignificantdecreaseinWCof1.51cm(-2.99;-0.04)comparedtothecontrolgroup(Table 3). Aftertwelvemonths,theWCintheinterventiongroupremainedlowerthaninthecontrolgroup (-1.28 cm; -2.79; 0.23) although no longer statistically significant. MS Z-scoredecreasedwith0.22 s.d. (-0.38; - 0.06) in the interventioncompared to control groupafterthreemonths,ofwhichmostoftheeffectwasattributabletoasignificantdecreaseof0.48s.d.inglucoseZ-score(-0.87;-0.09)andof0.09s.d.inWCZ-score(-0.18;-0.01)ininterventionpatients.TheeffectonMSZ-scorewasnotsustainedaftertwelvemonths.WefoundnointerventioneffectsonBMI.Ingeneral,changesinWCandBMIovertimevariedwidelybetweenteamsinboththeinterventionandcontrolgroup(Figure 2). In the intervention group, 20.1% of the participants had a clinically relevantimprovement(≥-5%WC)and20.6%hadaclinicallyrelevantdeterioration(≥+5%WC)inWCafter12months.Inthecontrolgroupthiswas17.8%andasubstantiallyhigher29.3%,respectively (p=0.075). To investigatewhethersubgroupsdiffered in their response tointervention, stratified analyses were performed for gender, age groups and housingfacility.Theinterventioneffectwasmostpronouncedinmales(WC:-2.42cm(-4.10;-0.74)andMSZ-score:-0.33s.d.(-0.55;-0.10))andyoungerparticipants(MSZ-score≤43years:-0.31s.d.(-0.58;-0.05)afterthreemonths(seeSupplementary Table 2).ThedecreaseinWCandMSZ-scorethroughinterventionwasstrongestinparticipantslivinginshelteredfacilities,afterthree(WC:-1.68cm(-3.34;-0.01);MSZ-score:-0.31s.d.(-0.51;-0.11))andtwelvemonths(WC:-2.63cm;-4.28;-0.98)whileinterventionpatientsinlong-termclinicalfacilitiesshowedasmallincreaseinMSZ-score(0.25s.d.(0.00;0.49))aftertwelvemonths.

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Table 3. Somaticoutcomesafter3and12monthsoflifestyleinterventioninin-patientswithseriousmentalillness:resultsofgenerallinearmixedmodelsanalyseswithadjustmentforage,gender,typeoffacilityandantipsychoticsideeffect.

Waist circumference (N=636)

Body mass index (N=654)

Metabolic syndrome Z-score (N=512)

β 95% CI p β 95% CI p β 95% CI p

Intervention effecta

3 monthsb -1.51 (-2.99;-0.04) 0.04 -0.13 (-0.49;0.23) 0.44 -0.22 (-0.38;-0.06) 0.008

12monthsb -1.28 (-2.79;0.23) 0.10 0.34 (-0.12;0.79) 0.14 -0.00 (-0.16;0.16) 0.99

Groupdifference(interventionvscontrol) 0.44 (-2.22;3.09) 0.75 -0.60 (-1.56;0.36) 0.22 -0.04 (-0.22;0.15) 0.70

Time effect only

3 months 1.11 (0.05;2.16) 0.04 0.10 (-0.15;0.36) 0.40 0.13 (0.01;0.26) 0.03

12months 0.75 (-0.31;1.80) 0.17 -0.04 (-0.36;0.29) 0.82 0.01 (-0.10;0.12) 0.89

Age 0.13 (0.02;0.24) 0.02 -0.02 (-0.06;0.02) 0.31 0.00 (-0.00;0.01) 0.51

Male gender 0.44 (-2.15;3.03) 0.74 -2.81 (-3.79;-1.83) .001 0.26 (0.08;0.44) 0.005

Shelteredfacility 0.76 (-4.67;6.18) 0.76 0.31 (-1.13;1.74) 0.67 -0.13 (-0.33;0.08) 0.20

Antipsychotic side effect on metabolism

Mild 1.09 (-2.04;4.22) 0.49 -0.34 (-1.20;0.52) 0.43 0.28 (-0.00;0.56) 0.06

Strong 2.73 (-0.38;5.83) 0.09 -0.05 (-0.91;0.81) 0.91 0.35 (0.07;0.63) 0.01aThecontrolgroupisthereferencegroup.bGroupxtime.

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

-20

-10

0

10

20 Waist change - intervention

Wai

st (c

m)

Team:N = 2 15 17 13 17 10 18 33 25 14 19 4 8 7 7

1 2 3 4 5 6 7 8 9 10 11 12 13 14

-20

-10

0

10

20 Waist change - control

Wai

st (c

m)

Team:N = 13 12 1 9 4 39 13 11 9 50 15 10 14 25

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15-6

-4

-2

0

2

4

6 BMI change - intervention

BM

I (kg

/m²)

Team:N = 2 15 22 14 22 11 19 38 25 16 21 6 10 9 11

1 2 3 4 5 6 7 8 9 10 11 12 13 14-6

-4

-2

0

2

4

6 BMI change - control

BM

I (kg

/m²)

Team:N = 13 13 2 11 8 42 14 14 9 58 15 12 15 27

Figure 2. Heterogeneity between teams inmean changes inwaist circumference andBMI aftertwelvemonths.Meanchangeinwaistcircumference(cm)andBMI(kg/m²)frombaselinetotwelvemonthsafterbaselineperteamwithNpatients.Errorbarsrepresentstandarderrorsofthemean.

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For comparabilitywith lifestyle intervention studies including SMIpatientswith aBMI ≥25kg/m28,weperformedsensitivityanalysesinthissubgroup.Findingsremainthesame:WCwasreducedwith1.79cm(-3.50;-0.08)atthreemonthsandatrendforreducedWCof1.59cm(-3.34;0.16)wasfoundattwelvemonths.MSZ-scoresdecreasedwith0.20s.d.(-0.40;-0.01)afterthreemonths.Again,nointerventioneffectsonBMIwerefound.

DISCUSSION

Main findingsThislarge,multi-site,randomizedcontrolledtrialshowedthatchangingtheobesogenicenvironment of SMI residential patients into a healthier environment significantlyreduced waist circumference and degree of metabolic syndrome after three monthsinterventioncomparedtocareasusual.Themagnitudeoftheseeffectsdecreasedwhen,afterthreemonths,stafftookoverthelifestyleactivities.Thisshowsthatimprovingtheobesogenicenvironmentcanevokebeneficialchangeswithouttargetingpatientsdirectly,butsustainabilityremainsachallenge. An innovative feature of the ELIPS intervention is the focus on the obesogenicenvironment as opposed to directly and solely targeting patients’ dietary and/orsedentarybehaviors13.Moreover,structuralchangesintheenvironmentwillaffecteverypatient,irrespectiveoftheirpersonalinterestinimprovingtheirlifestyles.Changingtheenvironmentusingasmallchangeapproachindeedresultedinasmallimprovement:1.5cminWCoverthreemonths.Ifthiscanbesustainedoveralongerperiodoftime,itwillhoweverleadtoclinicallyrelevantimprovementsinadiposityandtherebyreducingriskof cardiovasculardiseaseanddiabetes28,29. Earlier studies found that foreveryfive cmincreaseinWCtheriskofdeathincreasedwith13%forfemalesand17%formales30.

Comparison to previous studiesTwoearlierRCTsfocusedonresidentialpatients, targetingbothpatientsandstaffwitha 12-month lifestyle intervention with structural guidance of external coaches31,32.Forsbergandcolleaguesdidnotfind improvements inWCorglucose levels31.Thiswashowever a small study (n = 41). Hjorth and colleagues showed a reduction of 3.1 cminWC and stabilized fasting glucose levels versus increased glucose levels in controls,whichiscomparabletoourfindingofreductionsinWCandfastingglucoseZ-score.Theimprovement in glucose metabolism is consistent with studies showing that lifestyleinterventionsareeffectiveatpreventingtype2diabetesinthegeneralpopulation33.Thebeneficial effect on fasting glucose suggests that lifestyle improvements, possibly viaincreasedphysicalactivity,improveinsulinresistance34,35.Changesinphysicalactivitymayresultinchangesinbodycompositionwithreducedfatnessandincreasedmusclemass32,whichmayexplainthesignificanteffectsonWCbutnotBMI(Figure 2).Ameta-analysisoflifestyleinterventionsforSMIin-andoutpatientsconfirmedourresultsonWC(Cohen’s

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Chapter 3

d =-0.37;95%CI=-0.60;-0.13)andfastingglucose(Cohen’sd =-0.24;95%CI=-0.32;-0.10)6. Studiesusing individualand/orgroupcounseling sessions, forexampleDaumitandcolleagues8andMcKibbinetal36,foundasignificantdecreaseof2.0to3.7cminWCaftersixmonthsofexercise,weightmanagementorpsycho-educationalsessions.Thus,alifestyleinterventioninSMIresidentialpatientsfocusingontheobesogenicenvironmentmayyieldcomparableresultsasinterventionstargetingpatientsdirectlywithindividualorgroupcounseling.

Possible factors influencing intervention implementation and sustainabilityChangesinwaistcircumferencevariedwidelybetweenteams(Figure 2).Thisismostlikelyrelatedtotheeasewithwhichteams implementedandsustainednew lifestylehabits.Structuralaspectsplayedarole,likeenvironmentalfeaturesofthefacility(e.g.physicalactivityopportunitiesinurbanvsruralsetting37),availablebudget(e.g.forhealthyfoodproducts) and availability of staff members (e.g. nurses being scheduled to organizeactivities).Furthermore, logisticchanges(e.g.alteringthetypeofbreadofferedduringlunch)werepossiblymoreeasilyimplementedthanculturalchanges(e.g.offeringwalk-and-talk therapy38insteadofsittinginthecounselingoffice).Perhapsofmoreinfluencewereattitudesofstaff:nursesdifferedintheirexperienceofconflictingpriorities(e.g.ahighworkload),conflictswithroledefinitions(e.g.nursesarenotdieticiansorphysicaltherapists)andconflictswithownhealthbehaviors (e.g.givingagoodexamplebynotorderingpizzaduringnightshifts)39,40. Thepragmaticcharacterof theELIPS trialallowedthe interventiontobe tailoredtotheresourcesofthefacility.Moreover,regularstaffimplementedtheinterventionineverydaypracticeafterthreemonthsoflifestylecoaching,givingaclearindicationofwhatisattainablein‘real-world’settings.Thedesignofthestudy,consistingofanimplementationand amonitoring (support) phase, demonstrated the difficulty of sustaining achievedimprovements.Despite involvementofregularstaffinorganizing lifestyleactivitiesandembeddinglifestyleactivitiesinteams’workingroutine,themagnitudeofeffectsachievedatthreemonthsdecreasedintheninemonthsthereafter,whenstaffmemberswerelessfrequentlyguidedbylifestylecoaches.Thisisinlinewithfindingsfromameta-analysisof lifestyle interventionsbyBradshawet.al.40andthestudyofDaumitandcolleagues8 whereinitialsignificanteffectsonWCwerenolongersignificantwhenthefrequencyofsessionsdecreasedandtrainedstaffmemberstookovermostoftheactivitiesoflifestylecoaches.So,improvementsinWCandglucoselevelsarewithinreach,butsustainabilitymightbeachievedonlywhenstaffmembersareguidedonaregularbasisbyalifestylecoachwhoseprimaryresponsibilityistopromotethepatients’lifestyle.Thefrequencyoftheseguidingcontactsneededtosustainormaximizeresultsinthelong-term,shouldbeexplored,butlikelyneedstoexceedtwovisitsinninemonths. TheELIPSinterventionseemedtobeespeciallybeneficialformalesandpatientslivinginshelteredfacilities.Perhapsthelifestyleactivities,possiblythephysicalactivities,were

3

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moreappealingtomalethanfemaleparticipants.Staffinlong-termclinicalcarefacilitiesmighthaveexperiencedmoreobstaclesinchangingroutines,anticipatingdysregulationofthemostseverelyillpatients.However,theseresultsneedtobeinterpretedwithcautionassubanalysesinevitablycontainedfewerpatientsthanneededaccordingtothepowercalculation,whichwasbasedonthecomparisonofinterventionandcontrolgrouponly.

Strengths and limitationsStrengthsandlimitationsofthestudyarerelatedtothepragmaticcharacteroftheRCT.Thecontrolconditionwaslesscontrolledthanitwouldhavebeeninanexplanatorytrial19.Despitebeinginthecontrolcondition,staffmembersorpatientsmayhavetakeninitiativeto work on a more healthy lifestyle, following the trend in society. The interventionconditionwouldhavedifferedlessbetweenfacilitiesifwehadnotusedateamtailoredlifestyleplan.Usinganimplementationapproachhoweverlargelyincreasestheexternalvalidityofthestudyresults.Ourinclusionstrategyfurtherincreasedtheexternalvaliditybyavoidingselectionbiasofparticipatingpatients19.

IMPLICATIONS

A small change approach focusing on the obesogenic environment of patients livingin shelteredor long-termcare facilitieshas thepotential toproduceclinically relevantreductions in adiposity and thereby reduce cardiometabolic risk. However, our smallresultsindicatethatchangingtheobesogenicenvironmentaloneisnotenough.Itshouldbeconsideredaprerequisiteforimprovingpatients’health13andbepartofanintegratedapproachofmultiple targets, including sensiblepharmaceutical strategies.Anext stepwouldbe todevelopascalable (nursing-)programformaintenanceofhealthychangesandinitiativesinthefacilities,thatiseffective,affordableandsustainableinthelongterm.

54

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circulatorysysteminpatientswithbipolardisorderorschizophreniaintheNordiccountries.PLoS One.2013;8(6):1-7.

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6. Bruins J, Jörg F, BruggemanR, SlooffC, Corpeleijn E, PijnenborgM. Theeffects of lifestyleinterventions on (long-term) weight management, cardiometabolic risk and depressivesymptomsinpeoplewithpsychoticdisorders:Ameta-analysis.PloS one.2014;9(12):e112276.

7. CabassaL,Ezell J, Lewis-FernándezR.Lifestyle interventions foradultswithseriousmentalillness:Asystematicliteraturereview.Psychiatric Services.2010;61(8):774-782.

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9. BrarJS,GanguliR,PandinaG,TurkozI,BerryS,MahmoudR.Effectsofbehavioraltherapyonweightlossinoverweightandobesepatientswithschizophreniaorschizoaffectivedisorder.J Clin Psychiatry.2005;66(2):205-212.

10. Alvarez-JiménezM,Gonzalez-BlanchC,Vazquez-BarqueroJL,etal.Attenuationofantipsychotic-inducedweightgainwithearlybehavioral interventionindrug-naivefirst-episodepsychosispatients:Arandomizedcontrolledtrial.J Clin Psychiatry.2006;67(8):1253-1260.

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13. Swinburn B, Egger G, Raza F. Dissecting obesogenic environments: The development andapplication of a framework for identifying and prioritizing environmental interventions forobesity.Prev Med.1999;29(6):563-570.

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16. MelamedY, Stein-ReisnerO,GelkopfM, et al.Multi-modalweight control intervention forpeoplewithpersistentmentaldisorders.Psychiatr Rehabil J.2008;31(3):194-200.

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31. Forsberg KA, Björkman T, Sandman PO, SandlundM. Physical health-a cluster randomizedcontrolled lifestyle intervention amongpersonswith a psychiatric disability and their staff.Nordic Journal of Psychiatry.2008;62(6):486-495.

32. HjorthP,DavidsenAS,KilianR,etal. Improvingthephysicalhealthof long-termpsychiatricinpatients.Aust N Z J Psychiatry.2014;48(9):861-870.

33. Roumen C, Blaak EE, Corpeleijn E. Lifestyle intervention for prevention of diabetes:Determinantsofsuccessforfutureimplementation.Nutr Rev.2009;67(3):132-146.

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34. GoodyearP,LaurieJ,KahnM,BarbaraB.Exercise,glucosetransport,andinsulinsensitivity.Annu Rev Med.1998;49(1):235-261.

35. CorpeleijnE,SarisW,BlaakE.Metabolicflexibilityinthedevelopmentofinsulinresistanceandtype2diabetes:Effectsoflifestyle.Obesity reviews.2009;10(2):178-193.

36. McKibbinCL,PattersonTL,NormanG,etal.A lifestyle interventionforolderschizophreniapatientswithdiabetesmellitus:Arandomizedcontrolledtrial.Schizophr Res.2006;86(1):36-44.

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SUPPLEMENTARY MATERIALS

Supplementary Table 1. Categorizationofantipsychoticmedicationaccording to the strengthofthesideeffect(none,mildorstrong)oncardiometabolichealth. CategorizingisbasedontheDutchFarmacotherapeuticalCompass(FC),websiteUptoDate(UtD)andtheexpertopinion(EP)ofthreepsychiatrists.

Antipsychotic medication Source

No cardiometabolic influence

Aripiprazole FC

Haloperidol FC

Bromperidol EP

Flupenthixol FC

Pimozide FC

Sulpiride FC

Tiapride EP

Penfluridol EP

Fluphenazine UtD

Mild cardiometabolic influence

Risperidone FC

Quetiapine FC

Chlorprothixene EP

Levomepromazine EP

Paliperidone UtD

Periciazine EP

Pipamperon EP

Zuclopenthixol EP

Fluspirilene EP

Strong cardiometabolic influence

Clozapine FC

Olanzapine FC

Note: FC = (Dutch) National Health Care Institute (ZorginstituutNederland). Farmacotherapeutisch kompas.http://www.farmacotherapeutischkompas.nl/inleidendeteksten/i/inl%20antipsychotica.asp.Retrieved23 June2015; UtD = Selected adverse effects of antipsychotic medications for schizophrenia (www.uptodate.com).Retrieved3Augustus2015;EP=expertopinion.

58

Chapter 3

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