University of Groningen

Lifestyle interventions in patients with a severe mental illnessLooijmans, Anne

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Citation for published version (APA):Looijmans, A. (2018). Lifestyle interventions in patients with a severe mental illness: Addressing self-management and living environment to improve health. [Groningen]: Rijksuniversiteit Groningen.

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Multidimensional lifestyle intervention using a web tool to improve cardiometabolic health in severe mentally ill patients: results of a cluster randomized controlled trial (LION)

Anne Looijmans, Frederike Jörg, Richard Bruggeman, Robert A. Schoevers & Eva Corpeleijn

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ABSTRACT

BackgroundUnhealthylifestylebehaviorscontributetothealarmingcardiometabolicriskofseverementally ill (SMI)patients.Evidence-basedpractical lifestyle toolssupportingpatientsandstaffinimprovingpatients’lifestylearelacking.

Methods This multi-site randomized controlled pragmatic trial determined theeffectivenessofa12-monthmultidimensionallifestyleapproachincludingawebtooltoimprovepatients�cardiometabolichealthversuscare-as-usual.Inthewebtool,patientsandnurses(trainedinmotivationalinterviewing)mappedoutpatient�slifestylebehaviors,createdariskprofileandconstructedlifestylegoals.Lifestylegoalswerediscussedduringbiweekly regular care visits. Twenty-seven community-care and sheltered living teamswererandomizedintointervention(N=17)orcontrol(N=10)arm,including244patients(140 intervention/104 control, 49.2% male, 46.1±10.8 years) with increased waistcircumference(WC),BMIorfastingglucose.MainoutcomewasWCaftersixandtwelvemonthsintervention.SecondaryoutcomeswereBMIandmetabolicsyndromeZ-score.

Results General multilevel linear mixedmodels adjusted for antipsychoticmedicationshowed that differences in WC change between intervention and control were -0.15cm (95%CI:-2.49; 2.19) after six and -1.03 cm (95%CI:-3.42; 1.35) after twelvemonthsintervention; differenceswere not statistically significant. Also, no intervention effectswere found for secondaryoutcomes,even though the intervention increasedpatients’motivationtoimprovedietarybehavior.

Conclusion Amultidimensional web tool intervention facilitating nurses in addressingSMIpatients’lifestylechangedidnotimprovepatients’cardiometabolichealth.Lifestylecoachingrequiresspecificknowledgeandskills.Itshouldprobablybetheresponsibilityofprofessionallifestylecoachesinsteadofanotheradditionaltaskofnurses.

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INTRODUCTION

Amongpersonswithaseverementalillness(SMI),suchasschizophrenia,otherpsychoticor bipolar disorders, the prevalence of obesity is 45-55% and 10-15% have type 2diabetes1.Theseunfavorablecardiometabolichealthratesarealmostfourtimeshigherthaninthegeneralpopulation.Thisisrelatedtopsychiatricpharmacotherapy,thementaldisorderitselfandpatients’lifestylefactors1,2.AddressingSMIpatients’lifestylebehaviorsin regular mental health care could potentially lead to large cardiometabolic healthgains3.Mentalhealth(MH)nursesareassumedtobethemostadequateprofessionalsforthistaskduetotheirknowledgeoftheSMIpopulationandtheirfrequentcontactwithpatients4.However,mostMHnurseshavelimitedlifestyle-relatedknowledgeandskills,andlifestyletreatmentprotocolsarelacking.Evidence-basedpracticallifestyletoolsthatsupportbothpatientsandstaffinimprovingpatients’lifestylearethereforeneeded. EarlierstudiessuggestthatlifestyleinterventionsinSMIpatientscouldsuccessfullyreduce body weight and cardiometabolic risk factors such as waist circumference,triglyceridesandfastingglucose5-7.However,manytrialshadsmallsamplesizesorwereoflowmethodologicalquality.Also,manyinterventionswereimplementedunderstrictlycontrolledconditionsbyexternalstaffwhoincludedmainlythemoremotivatedpatients,therefore the external validity of these outcomesmay be limited8. The availability ofmodern techniques such as internet, web tools and laptops or tablets provides newopportunities for state-of-the-artapproachesof lifestyle coaching. Inaddition, lifestyleprograms should meet the needs of MH nurses working in daily mental health care,astheyareexpectedtodiscussSMIpatients’ lifestylebehaviorsasapartoftheirdailyroutine. SeveralbehavioraltechniqueswereeffectiveinchanginglifestylebehaviorsleadingtoanimprovedBMI,weightstatusandcholesterollevelsinmanypatientgroups,includingoverweightandobeseadults9-11.Motivationalinterviewing(MI)byMillerandRollnickisapatient-centeredapproachtoincreaseintrinsicmotivation12.Thestage-of-changemodelofProchaskaandDiClementepresentsfivestagesofchangethateachreflectpatients’levelofmotivationandself-efficacytochange13.Bothapproachesworkwellforpatientswhoarenotreadytochangeyet.Alsostrategies likemobilizingsocialsupportandtheuse of self-management techniques such as creating awareness, goal-setting and self-monitoring are considered effective ingredients of interventions to change lifestylebehavior9,14. We present a 12-month multidimensional lifestyle approach in which MHprofessionalsinregularcareweresupportedtoaddresslifestylebehaviorchangeinSMIpatients.MHnursesweretrained inMIandstage-of-changeapproachskillsand intheuseofawebtoolthatprovidedalifestylescreeningandhadbuiltinbehavioralchangetechniques15.ThepragmaticLifestyleInterventionsforseverementallyillOutpatientsintheNetherlands (LION) trial studiedwhether this lifestyle approach stabilizedor evenimprovedabdominalobesityandothercardiometabolicriskfactorsinSMIpatients.We

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hypothesizedthattheinterventionstabilizedorreducedwaistcircumference(WC),BodyMass Index (BMI) andMetabolic Syndrome Z-score (MS Z-score) after six and twelvemonthsinterventioncomparedtocare-as-usualduetopatients’increasedmotivationtoimprovephysicalactivitylevelsanddietaryhabits.

METHOD

TheLIONstudyprotocolwaspublishedpreviously16.TheLIONstudyisapragmaticsingle-blindmulti-siteclusterrandomizedcontrolledtrial.TheMedicalEthicalCommitteeoftheUniversityMedicalCenterGroningenapproved the study. Eligiblepatients receivedaninformationletterandsignedinformedconsentbeforeparticipatinginthetrial.ThestudywasperformedinaccordancewiththeDeclarationofHelsinkiandregisteredintheDutchTrialRegistry(NTR3765,www.trialregister.nl,21December2012).

Participants, recruitment and randomizationSMI patients from 21 Flexible Assertive Community Treatment (F-ACT)17 and eight shelteredfacilityteamsoffivementalhealthorganizationsintheNetherlandswereinvitedforthestudywithin12monthsafterinclusionofteams(January2014toOctober2015).F-ACT teams offer community-dwelling patients care in their own living environment,rangingfromlowintensivesupporttohighintensivetreatment17.Shelteredfacilitiesofferpatientsservicesandhousing in thecommunity.F-ACTteamswerematchedbasedonorganization, caseload size,patients’meanage,meandurationofpatients’ admission,most prevalent diagnosis and location (urbanor rural) andwere randomizedfifty-fiftyintointerventionorcontrolarm.Randomizationwasperformedusingarandomnumbergenerator by a researcher of the research team not involved in training of staff andrecruitmentofpatients.Toavoidspillovereffectsoftheintervention,shelteredhousingteamswereassignedtothesameconditionascollaboratingF-ACTteams.Insometeamsallnursesparticipated,inotherstheteamleaderselectednurses. MHnursesinvitedpatientstoparticipateiftheirannualphysicalscreeningshowedat leastoneof the followingmetabolic risk factors:WC>88/102cm (females/males);fastingglucose>5.6mmol/LorHbA1c>5.7%or>39mmol/mol;BMI>25kg/m².Exclusioncriteriawerepregnancy,BMI<19kg/m²,or impairmenttoperformphysicalactivity. Intotal,with alpha=0.05 and power 0.80, 275 patientswere needed to detect a clinicalrelevantreductionof5.8cminprimaryoutcomeWC18,takingintoaccount10%dropout.

Intervention Beforestartoftheintervention,MHnursesreceivedonedayoftrainingonMI12,thestage-of-changemodel13,risksofunhealthylifestylebehaviors,thewebtool‘TrafficLightMethodforsomaticscreeningandlifestyle’(TLM)andenvironmentalfactorsrelatedto lifestylebehaviors15.Afterthreemonths,anevaluationsessionwasplannedtodiscussprogress.

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Patients and nurses worked in the web tool during regular care visits, plannedaccording to the intervention to take place on average once every twoweeks. In thelifestylebehaviorscreeningphase,patientsandnursesmappedoutthepatients’lifestylebehaviors.TLMdisplayedariskprofilewith lifestylebehaviors ingreen,orangeorred,depending on the level of risk. Upon this, a lifestyle plan with attainable goals wasconstructed. In the follow-up phase, patients’ progress in achieving the lifestyle goalswasevaluatedinfollow-upreportsduringbiweeklyregularcarevisitsforapproximately15minutes.Aftersixmonths,patientsandnursesmappedoutlifestylebehaviorsagain,updateda(new)lifestyleplanandevaluatedthisplanforthenextsixmoremonthsuntilthetrialended.Patientinthecontrolconditionreceivedcare-as-usual.

Measurements and outcomesPrimary outcome was waist circumference (WC; cm) after six and twelve monthsintervention. Secondary outcomeswereBodyMass Index (BMI; kg/m2) andmetabolicsyndromeZ-score(MSZ-score;SD).Informationonage,sex,diagnosisandmedicationusewasderivedfrompatientrecordforms.Aspartofstandardcare,trainedRoutineOutcomeMonitoring(ROM)nursesscreenpatientsannuallyonphysicalandpsychosocialoutcomesaccording toprotocolduringROMscreenings19. Thesedatawereusedasbaselineand12-monthsmeasures.Fortheadditionalphysicalexamandlabtestaftersixmonthsofintervention(6-monthsmeasure),participantsreceivedasmallfee(€5,00/$5,45).ROM-nurseswereblindedtotreatmentallocation. WC, weight, height, systolic and diastolic blood pressure (BP) were measuredaccordingtoprotocol16.Fastingbloodsampleswerecollectedina(hospital)laboratoryforlevelsoflipids(totalcholesterol,LDL-cholesterol,HDL-cholesterolandtriglycerides)andglucosemetabolism(glucose,HbA1c).Ifnotfasting,thiswasroutinelyindicatedontheform. The metabolic syndrome was defined as the presence of three or more of thefollowing criteria20:WC≥ 88/102 cm (female/male); systolic BP ≥ 130 and/or diastolicBP ≥ 85 mmHg or receiving antihypertensive medication; HDL-C < 1.03/1.3 mmol/L(female/male)orreceivinglipid-loweringmedication; fasting triglycerides≥1.7mmol/Lor receiving lipid-loweringmedication;and fastingglucose≥6.1mmol/L21or receivingantihyperglycemicmedication.Whenfastingglucose levelswerenotavailable,patientswereconsideredtofulfilltheglucoseriskcriterioniftheyreportedtohavediabetesorifHbA1c≥42.0mmol/mol22.SincethedichotomizationoftheMScomponentsreducessensitivity for changes over time, the individual components were standardized intoZ-scores(withHDL-cholesterolZ-scoremultipliedby-1)23,24andthesumdividedbyfivewasusedasacontinuousvariableforthedegreeofmetabolicsyndrome(MSZ-score).BPwasstandardizedusingmeanarterialpressure(MAP). Antipsychotic medication (AP) was categorized in three groups according to thestrength of the side effect on cardiometabolic health (no, mild, or strong) based onliterature25,26.

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Patients’readinesstochangephysicalactivityordietarybehaviorwasassessedbyaquestionrepresentingthefivephasesofthestage-of-changemodel13.Answersrangedfrom“notwilling to changewithin sixmonths” (precontemplation), “willing to changewithinsixmonths”(contemplation),“willingtochangewithinonemonth”(preparation),“considermyself acting healthy for less than sixmonths” (action) to “considermyselfactinghealthyformorethansixmonths”(maintenancephase).

AnalysesDatawere analyzed using SPSS version 2227, considering a p-value of 0.05 statisticallysignificant. The intervention effect was tested using an intention-to-treat approachwith a subject-specific model to adjust for clustering of patients within teams usingan unstructured variance structure, and controlling for the block design. Resultswerepresentedasmeans(95%confidenceinterval)ormedian[25-75thpercentile].Instratifiedanalyses,interventioneffectsweretestedforpre-specifiedsubgroupsbasedonsex,ageand type of housing. In explorative per-protocol analyses, adhering participants (high-users)werecomparedtothecontrolgroupusingthesamelinearmixedmodelsasdescribedabove. Participantswho filled in at least one lifestyle behavior screening, constructedlifestylegoalsandcompletedtenormorefollow-upreports,wereconsideredhigh-users. Intervention effects on patients’ readiness to change dietary or physical activitybehavior were tested by comparing the percentage intervention participants thatshiftedtowardsmorereadinesstochangefrombaselinetosixandtwelvemonthstothepercentageparticipantsinthecontrolgroup,usingChi-squaretest.

RESULTS

Intotal,244patients(144intervention;104control)wereincludedinthetrial,ofwhom49.2%wasmaleandthemeanagewas46.1±10.8years(Table 1).Thesourcepopulationcontained835eligiblepatients.Patients intheinterventiongroupwereonaverage4.3yearsyounger(p=.002)andhadahigherBMI(p=0.045)thanpatientsinthecontrolgroup(Table 2).Moreteamsendedupintheintervention(N=17)thaninthecontrolarm(N=10)duetolargereorganizationsthattookplaceinmentalhealthcareduringthefirstphaseofthetrial,leadingtoteamsbeingcombined,splitorabolishedaftertherandomizationprocedurewascompleted(Figure 1)16. In the intervention group, 108 of all 140 (77%) patients completed at least onelifestylebehaviorscreeningandconstructedsubsequentlifestyleplanswithlifestylegoals(Figure 2).Ofthose,low-users(N=13;12%)hadnofollow-upreports,andmedium-users(N=60;56%)andhigh-users(N=35;32%)hadamedianof4.0[2.3;7.0]and14.0[11.0;18.0] follow-upreports, respectively.Patientsconstructed lifestylegoalsmostlyrelatedtodiet(N=141;41.7%),physicalactivity(N=83;24.6%)oracombinationofboth(N=37;10.9%),but alsogoals related to smoking (N=17;5.0%)and sleepingbehaviors (N=15;

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4.4%).Atbaselineorsecondmeasure,almostallinterventionpatients(N=99;92%)setatleastonegoalrelatedtoenergyintakeorexpenditure.

Table 1. BaselinecharacteristicsofLIONstudyparticipants.

N Total Intervention group Control group p

General information

Teams,n 27 17 10

Nurses,n 138 82 56

Patient characteristics

Patients,n 244 140 104

Age,mean±SD,years 240 46.1±10.8 44.3±10.9 48.6±10.2 .002

Malesex,n(%) 120(49.2) 66(47.1) 54(51.9) .46

Housing,n 240 .38

F-ACTteams(patients) 19(193) 12(108) 7(85)

Shelteredlivingteams(patients) 8(51) 5(32) 3(19)

ResultsfortheinterventionandcontrolgroupovertimearepresentedinFigure 3 and Supplementary Table 1.Inintention-to-treatanalyses,WCchangewas-0.15cm(-2.49;2.19)aftersixand-1.03cm(-3.42;1.35)aftertwelvemonthsofinterventioncomparedtothecontrolgroup,butthedifferencebetweengroupswasnotstatisticallysignificant,neitherforBMIandMSZ-score(Table 3).Comparedtothecontrolgroup,nosignificantintervention effects onWC, BMI orMS Z-score were found formales vs females, foryoung(≤46.0years)vs older(>46.0years)participantsandforF-ACTvs sheltered housing participants(Supplementary Table 2).Forexplorativeanalyses,35ofthe140interventionparticipants(25%)werecategorizedashigh-usersofthewebtool.Inthehigh-usergroup,WCchangewas -1.87cm(-7.31;1.56)aftersixand -1.69cm(-4.96;1.58)after twelvemonthsof interventioncomparedtocontrols,althoughnotstatisticallysignificant.BMIandMSZ-scoredidnotdifferovertimeinhigh-userscomparedtocontrols. At baseline, the readiness-to-change for physical activity behavior differedsignificantlybetweeninterventiongroupandcontrolgroup:48(52.2%)controlpatientsconsideredthemselveshealthywithregardtophysicalactivityforlessormorethansixmonthscomparedto32(29.4%)patientsintheinterventiongroup(p<0.00).Overtime,nosignificantlydifferentchangesinstage-of-changewerefound.Withregardtodietarystage-of-changeatbaseline,nodifferenceswerefoundbetweeninterventionandcontrolgroup.Aftersixmonthsofintervention,morepatientsintheinterventiongroupincreasedin readiness-to-change their dietary behaviors (40% vs 23%) and fewer decreased inreadiness-to-change (19% vs 39%),when compared to control (p=0.049). After twelvemonths,40%increasedand26%decreasedintheinterventiongroupcomparedto20%increaseand29%decreaseinthecontrolgroup(p=0.023)forreadiness-to-changetheirdietarybehaviors.

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Table 2. BaselineclinicalcharacteristicsofLIONstudyparticipants.

N Total Intervention group Control group p

Body composition

Waistcircumference,cm:mean±SD

Male 114 111.3±12.7 112.3±14.2 110.0±10.7 .32

Female 116 110.2±16.3 111.9±17.0 107.8±15.0 .18

BodyMassIndex(BMI), kg/m2:mean±SD

233 32.0±6.4 32.7±7.2 31.1±5.1 .045

BMIcategories,n(%): 233 .36

Normal(BMI<25) 21(9.0) 11(8.3) 10(10.0)

Overweight(BMI25-29) 81(34.8) 44(33.1) 37(37.0)

ObeseI(BMI30-34) 70(30.0) 40(30.1) 30(30.0)

ObeseII(BMI35-39) 36(15.5) 19(14.3) 17(17.0)

ObeseIII(BMI≥40) 25(10.7) 19(14.3) 6(6.0)

Bloodpressure(BP),mmHG:mean±SD

SystolicBP 230 133.1±17.0 132.9±17.3 133.4±16.7 .82

DiastolicBP 227 84.1±10.5 85.0±10.5 82.9±10.5 .15

UseofBPloweringmedication,n(%) 171 45(26.3) 21(22.1) 24(31.6) .16

Lipids

Totalcholesterol,mmol/L:mean±SD 199 5.08±1.11 5.17±1.05 4.96±1.18 .20

HDL-cholesterol,mmol/L:mean±SD

Male 107 1.03±0.23 1.01±0.23 1.05±0.22 .38

Female 103 1.36±0.47 1.35±0.53 1.36±0.37 .95

LDL-cholesterol,mmol/L:mean±SD 196 3.07±0.94 3.09±0.88 3.05±1.02 .75

Triglycerides,mmol/L:median (25-75thpercentile)

94 1.73(1.08-2.41) 1.68(1.03-2.53) 1.76(1.22-2.15) .90

Useoflipidloweringmedication,n(%) 171 45(26.3) 22(22.7) 23(31.1) .22

Glucose metabolism

Fastingglucose, mmol/L:median(25-75thpercentile)

93 6.0(5.4-7.0) 5.7(5.3-7.0) 6.2(5.7-7.0) .09

HbA1c,%:median(25-75thpercentile) 190 36.0(33.3-41.0) 36.0(33.0-39.0) 38.0(34.0-44.0) .009

Diagnosisofdiabetesa 235 73(31.1) 36(27.1) 37(36.3) .13

Useofglucoseloweringmedication,n(%)

162 37(22.8) 17(18.5) 20(28.6) .13

Metabolicsyndrome,n(%) 84 56(66.7) 25(56.8) 31(77.5) .37

MetabolicsyndromeZ-scoreb, mean±SD

84 0.65±0.92 0.61±0.96 0.69±0.88 .68

Psychiatric characteristics

Psychiatricdiagnosis,n(%) 243

Psychoticdisorder 140(57.6) 86(61.4) 54(52.5) .16

Mood disorder 68(28.0) 36(25.7) 32(31.1) .36

Personality disorder 64(26.3) 34(24.3) 30(29.1) .40

Anxiety disorder 33(13.6) 18(12.9) 15(14.6) .70

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Table 2. BaselineclinicalcharacteristicsofLIONstudyparticipants(continued).

N Total Intervention group Control group p

Psychiatriccomorbidityc,n(%) 243 75(30.9) 40(28.6) 35(34.0) .37

Useofantipsychotics,n(%) 217 187(86.2) 108(87.8) 79(84.0) .43

Antipsychoticbasedonmetabolic sideeffectd,n(%)

224 .74

Noeffect 71(31.7) 42(33.1) 29(29.9)

Mediumeffect 76(33.9) 44(34.6) 32(33.0)

Higheffect 77(31.7) 41(32.3) 36(37.1)

Note:SIconversionfactors:toconverttotalcholesterol,HDL-cholesterolandLDL-cholesteroltomg/dL,dividevaluesby0.0259;toconverttriglyceridestomg/dL,dividevaluesby0.0113;toconvertfastingglucosetomg/dL,dividevaluesby0.0555.BaselinedifferencesweretestedwithStudent’sT,MannWhitneyUorChisquaretests.aDiabeteswasdefinedbasedonreporteddiagnosisofdiabetes,useofantihyperglycemicmedication,fastingglucose≥7.1mmol/LorHbA1c≥48mmol/mol.bThemeansandstandarddeviations(SD)ofthepatientsrangingwithinhealthyreferencevalueswereusedtostandardizeHDL-C(1.1-2.0mmol/Linfemaleand0.9-1.7mmol/Linmalepatients),triglycerides(≤2.2mmol/L)andfastingglucose(≤7.1mmol/L)orHbA1c(<8.0%).cTwoormoreofthedefineddiagnoses.dIfnoantipsychoticmedicationwasused,thiswascategorizedasthenoeffectgroup.

Intervention groupN=140

Started interventionN=122

Set goals to achieveN=108

Never started workingwith the web tool

N=18 (13%)

Never set goals in the web tool

N=14 (12%)

Low-userN=13 (12%)

Medium-userN=60 (56%)

High-userN=35 (32%)

Figure 2. InterventionadherenceofpatientsintheLIONtrial.Whenparticipantsfilledinatleastonelifestylebehaviorscreeningandconstructedalifestyleplanwithlifestylegoals, they were considered a low-user when no follow-up reports were completed, amedium-user whenbetweenoneandninefollow-upreportswerecompletedandahigh-userwhentenormorefollow-upreportswerecompleted.

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Table 3.Somaticoutcomesafter6and12monthsoflifestyleinterventioninSMIpatients:resultsofgenerallinearmixedmodelsanalyseswithadjustmentforantipsychoticsideeffectonmetabolism.

Waist circumference(N=238)

Body Mass Index(N=240)

Metabolic syndromeZ-score (N=115)

β 95% CI p β 95% CI p β 95% CI p

Interventioneffecta

6 monthsb -0.15 (-2.49;2.19) 0.90 0.27 (-0.32;0.85) 0.38 -0.25 (-0.69;0.18) 0.24

12monthsb -1.03 (-3.42;1.35) 0.39 0.18 (-0.49;0.86) 0.60 -0.30 (-0.66;0.05) 0.09

Groupdifference(interventionvscontrol) 2.26 (-3.91;8.44) 0.45 1.47 (-0.17;3.11) 0.08 -0.10 (-0.54;0.34) 0.63

Timeeffectonly

6 months -0.15 (-1.84;1.54) 0.86 -0.15 (-0.57;0.27) 0.49 0.10 (-0.19;0.40) 0.48

12months 1.56 (-0.23;3.34) 0.08 -0.26 (-0.77;0.24) 0.31 0.08 (-0.17;0.33) 0.51

Antipsychoticsideeffectonmetabolismc

Medium 1.99 (-0.91;4.90) 0.18 0.90 (-0.01;1.81) 0.05 -0.07 (-0.51;0.36) 0.74

High 0.17 (-3.04;3.38) 0.92 0.08 (-1.09;1.25) 0.90 0.40 (0.00;0.80) 0.049aThecontrolgroupisthereferencegroup.bGroupxtime. cNoantipsychoticsideeffectonmetabolismisthereferencecategory.

Figure 3. Somaticoutcomesatbaseline,sixandtwelvemonthspercondition.Estimatedmarginalmeansandstandarderrorsfora)waistcircumference,b)BMIandc)metabolicsyndromeZ-scoreforinterventionandcontrolgroupatbaseline,sixandtwelvemonths.

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DISCUSSION

Considering the large influence of unhealthy lifestyle behaviors on the alarmingcardiometabolicriskofSMIpatients,evidence-basedpracticallifestyletoolsthatfacilitatebothpatientsandstaffinregularmentalhealthcarepracticetoimprovepatients’lifestyle,are needed. This trial showed that a 12-monthmultidimensional lifestyle approach inwhichMHnursesweretrainedinMIandthestage-of-changeapproach,andhadawebtool at their disposal providing lifestyle knowledge andbehavioral change techniques,did not improve abdominal adiposity and cardiometabolic health in SMI patients. Theinterventionincreased,however,patients’motivationtochangetheirdietarybehavior.Thedifferenceinwaistcircumferenceinthe35mostactiveusersseemedmorepronounced(-1.87 cm (-7.31; 1.56) at six and -1.69 cm (-4.96; 1.58) at twelvemonths) comparedto the interventiongroupasawhole (-0.15cm (-2.49;2.19)and1.03cm (-3.42;1.35)respectively).Theresultsfoundinthehigh-usersgroupwerenotstatisticallydifferentcomparedtocontrols,whichcouldbeduetoalackofpower. Thelackofoveralleffectivenesscanbesoughtinthefactthatthemultidimensionalinterventionitselfdoesnotleadtoimprovedhealth,orinthefactthattheinterventionwasinsufficientlyimplemented,whichinherentlyleadstoalackofeffect.Wecomparedthecurrentlifestyleapproachtofourpreviouslypublished,largelifestyleinterventionstudiesinSMIpatientstogetinsightsinpotentiallysuccessfulinterventionandimplementationelements. The ACHIEVE28, In SHAPE29 and STRIDE30 lifestyle interventions consisted ofweeklyandmonthlylifestylesessionsincludingmandatorysupervisedexercises,resultinginaweightreductionof2.6to3.2kginpatientsafter12or18monthsofintervention.IntheCHANGE31study,well-trainedhealthprofessionalsmetpatientsonceaweektodiscusspersonallifestylegoals.Thisinterventiondidnotresultinimprovementsincardiovasculardiseaseriskscoreorcardiometabolicriskfactors. Withregardtotheinterventionelements,thecurrentandtheCHANGE31interventiontargetedpatients’intrinsicmotivationandself-managementtoengenderbehaviorchangeof choice, but did not includemandatory dietary of exercise sessions. In the generalpopulation, the relationbetween the intrinsic intention-to-changeandactualbehaviorchangeisweak32.ThisrelationmightevenbeweakerinSMIpatientsduetoproblemswithrewardanticipatingsystems33andnegativesymptomssuchaslackofinitiatingbehavior34.However, increasing patients’ intrinsic motivation could lead to prolonged efforts toact healthy after interventions end. The more promising interventions ACHIEVE28, InSHAPE29andSTRIDE30, includedguided (exercise) sessions,up to threetimesaweek28.Mandatorysessionscoulddecreasepermissivenessandincreasecommitment:meetingalifestylecoachforguidedexercisesessionsresultedintheattendanceof2.5timesmoresessions than not having these appointments29.Guidedexercise sessions could reducepatients’barrierstoexerciseandincreasepatients’self-efficacy,whichisrelatedtohealthbehavior changes35. Additionally,wemay consider an alternative approach: improvingthe obesogenic environment.We have shown earlier that this (also) has potential to

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improvebodycompositionandcardiometabolicriskinSMIpatients35.SMIpatientsmayneedinterventionswithmorestructuralandenvironmental(mandatory)elements31 that decreasethelevelofpermissiveness. With regard to the implementation,we choose regularMHnurses todeliver theintervention as part of their regular care contacts. In the more effective trials28,29,30,specially appointed professionals had been allocated dedicated hours for lifestylecoachingandguidingexercises,withtheexclusiveprioritytoimprovepatients’lifestyle.Thismayseemtosuggestthatlifestylecoachingrequiresspecificknowledgeandskills,andprofessionalsneed tobeappointed specifichoursand responsibility toeffectivelydeliverlifestylecoaching.Wemayneedtoacknowledgethatlifestylecoachingisamoreintensiveandextendedcaretrajectory36ratherthanbeingoneofthe(many)tasksandresponsibilitiesofMHnurses.

Factors influencing the implementation and impact of the interventionSeveralfactorsmayhaveinfluencedtheimplementationandimpactoftheintervention.LargebudgetcutbacksinmentalhealthorganizationsatstartofthistrialresultedinanunexpectedincreasedworkloadforMHprofessionalsandthetransitionofSMIpatientstoamorelimitedformofgeneralmentalhealthcare.ThismayhaveloweredMHnurses’opportunityandmotivationto implementthe intervention37 on the one hand and loss to follow-upofprobably themoststablepatientsontheotherhand.Furthermore,MIisconsideredadifficulttechnique.AlthoughmostnurseshadMItrainingbefore,theMIskillsinsomenursesmighthavebeeninsufficienttoincreasepatients’intrinsicmotivation.One-dayoftrainingtoaddressMI,stage-of-changeapproachesandgetfamiliarwiththewebtool,maybetooshort.Frequentsupervisionsessionswereofferedbutduetotheincreasedwork load, nurseshardly attended them. In addition,filling in the follow-upreportswasreportedtotakemuchlongerthantheexpectedfifteenminutesperregularcarevisit.Somenursesalsoexperiencedpracticalproblemssuchasnocomputer/laptopavailableornoaccesstointernetinruralareasintheNetherlands.

CONCLUSION

A multidimensional web tool intervention facilitating nurses in addressing lifestylebehaviorchangeinSMIpatientsdidnotimprovecardiometabolichealth.Itdidhoweverimprove the intention to change dietary behavior. Since the translation of intentionsinto actual behavior is especially challenged in this population, more structural andenvironmentalapproachesshouldbeconsideredtosupportimprovementsinreadinesstochange.Inaddition,weproposethatlifestylecoachingforSMIpatientsisconsideredacomplexspecialization,demandingspecificknowledgeandskills,andshouldprobablynotbeoneofthemanytasksofMHnursesbutrathertheresponsibilityofappointedlifestyleprofessionals.

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35. LooijmansA,StiekemaAPM,BruggemanR,VanderMeerL,StolkRP,SchoeversRA,JörgF,Corpeleijn E. Changing the obesogenic environment to improve cardiometabolic health inresidential patients with a severe mental illness: Cluster randomized controlled trial. Br J Psychiatry.2017;211(5):296-303.

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SUPPLEMENTARY MATERIALSSupplementary Table 1. Estimatedmarginalmeansandstandarderrors forwaistcircumference,Bodymassindex(BMI)andmetabolicsyndrome(MS)Z-scoreforinterventionandcontrolgroupatbaseline,sixandtwelvemonths.

N Baseline 6 months 12 months

Waist circumference (cm)

Intervention 135 112.9±1.9 112.6±2.0 113.4±2.0

Control 103 110.6±2.3 110.5±2.4 112.2±2.4

Body mass index (kg/m2)

Intervention 137 32.86±0.56 32.98±0.59 32.78±0.60

Control 103 31.38±0.64 31.24±0.66 31.12±0.68

Metabolic syndrome Z-score (SD)

Intervention 58 0.64±0.15 0.48±0.17 0.42±0.14

Control 57 0.74±0.16 0.84±0.17 0.82±0.15

140

Chapter 7

Supp

lem

enta

ry Ta

ble

2. W

aistcircum

ference,bod

ymassind

exand

metab

olicsy

ndromeZ-scoreaft

er6and

12mon

thso

flife

styleinterven

tioninSMIp

atien

ts

stratifi

edfo

rgen

der,agegrou

pan

dtype

offacility:resultsoflinea

rmixed

mod

elsa

nalysesw

ithadjustm

entforanti

psycho

ticside

effe

ctonmetab

olism

.

WAI

ST C

IRCU

MFE

REN

CE

Gen

der

Age

Faci

lity

Mal

es(n

=119

)Fe

mal

es(n

=119

)≤4

6 yr

s(n

=120

)>4

6 yr

s(n

=118

)F-

ACT

(n=1

89)

Shel

tere

d(n

=49)

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

Interven

tioneff

ecta

at 3

mon

thsb

0.17

-3.03;3.38

0.91

-0.63

-4.10;2.83

0.72

-1.63

-5.17;1.91

0.36

0.57

-2.75;3.88

0.73

-0.20

-2.91;2.52

0.89

-0.77

-4.66;3.12

0.69

at1

2mon

thsb

-1.04

-3.86;1.78

0.47

-0.74

-4.70;3.22

0.71

-1.13

-5.07;2.80

0.57

-2.09-5.06;0.89

0.17

-0.85

-3.62;1.91

0.54

-2.27

-6.53;1.99

0.28

Grou

pdiffe

rence

(interven

tionvs

control)

2.75

-4.91;10.41

0.46

2.24

-5.16;9.64

0.53

4.86

-3.06;12.79

0.21

1.53

-3.65;6.70

0.56

5.76

-1.31;12.83

0.10

-7.39

-20.94

;6.16

0.23

Timeeff

ecto

nly

3 m

onth

s-0.85

-3.12;1.43

0.46

0.75

-1.82;3.32

0.56

2.04

-0.79;4.88

0.16

-1.50-3.63;0.62

0.16

-0.60

-2.52;1.32

0.54

2.50

-0.55;5.54

0.10

12mon

ths

1.48

-0.57;3.52

0.15

1.66

-1.38;4.71

0.28

3.18

-0.03;6.38

0.05

0.59

-1.44;2.61

0.57

1.24

-0.81;3.29

0.23

3.62

0.28

;6.96

0.04

BODY

MAS

S IN

DEX

Gen

der

Age

Faci

lity

Mal

es(n

=120

)Fe

mal

es(n

=120

)≤4

6 yr

s(n

=120

)>4

6 yr

s(n

=120

)F-

ACT

(n=1

90)

Shel

tere

d (n

=50)

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

Interven

tioneff

ecta

at 3

mon

thsb

0.27

-0.53;1.06

0.51

0.27

-0.63;1.17

0.56

0.03

-0.81;0.87

0.94

0.27

-0.63;1.17

0.55

0.24

-0.45;0.94

0.49

0.31

-0.65;1.27

0.51

at1

2mon

thsb

0.59

-0.29;1.48

0.19

-0.11

-1.15;0.92

0.83

0.00

-1.09;1.10

0.99

0.06

-0.85;0.96

0.90

0.23

-0.54;1.00

0.56

-0.05

-1.35;1.24

0.93

Grou

pdiffe

rence

(interven

tionvs

control)

1.01

-1.60;3.61

0.43

1.86

-0.76;4.48

0.16

1.95

-0.30;4.19

0.09

1.16

-1.32;3.64

0.36

2.15

0.28

;4.01

0.02

-0.94

-4.35;2.47

0.58

Timeeff

ecto

nly

3 m

onth

s-0.17

-0.73;0.39

0.54

-0.10

-0.75;0.56

0.77

0.22

-0.45;0.89

0.52

-0.36-0.92;0.20

0.20

-0.15

-0.63;0.34

0.55

-0.04

-0.78;0.70

0.91

12mon

ths

-0.51

-1.15;0.14

0.12

-0.03

-0.83;0.76

0.94

0.30

-0.59;1.19

0.50

-0.53-1.15;0.10

0.10

-0.36

-0.94;0.21

0.21

0.30

-0.72;1.33

0.55

7

141

LION

– somatic outcom

es

Supp

lem

enta

ry T

able

2. W

aistcirc

umference,bod

ymassinde

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dmetab

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drom

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12mon

thsoflifestyleinterven

tioninSMI

patie

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gegroup

and

typ

eoffa

cility:resultsoflin

earmixed

mod

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ithadjustm

entforan

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ecton

metab

olism

(con

tinue

d).

MET

ABO

LIC

SYN

DRO

ME

Z-SC

ORE

Gen

der

Age

Faci

lity

Mal

es(n

=61)

Fem

ales

(n=4

7)≤4

6 yr

s(n

=55)

>46

yrs

(n=6

0)F-

ACT

(n=7

9)Sh

elte

red

(n=3

6)

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

β95

% C

Ip

Interven

tioneff

ecta

at 3

mon

thsb

-0.22

-0.87;0.44

0.49

-0.65

-1.72;0.42

0.14

-0.31

-0.84;0.22

0.25

-0.45-1.03;0.13

0.09

-0.37

-0.93;0.19

0.18

-0.03

-0.17;0.11

0.67

at1

2mon

thsb

-0.35

-0.88;0.19

0.19

-0.52-0.98;-0.060.03

-0.35

-0.92;0.22

0.21

-0.51-0.92;-0

.09

0.02

-0.13

-0.58;0.32

0.57

-0.28

0.81

;0.26

0.31

Grou

pdiffe

rence

(interven

tionvs

control)

0.08

-0.42;0.57

0.75

-0.14

-0.72;0.43

0.62

0.09

-0.71;0.88

0.81

-0.21-0.75;0.33

0.45

-0.16

-0.83;0.52

0.63

-0.15

-0.69;0.38

0.57

Timeeff

ecto

nly

3 m

onth

s-0.04

-0.47;0.40

0.85

0.56

0.00

;1.11

0.05

0.02

-0.30;0.34

0.90

0.60

0.27

;0.93

0.01

0.26

-0.15;0.66

0.19

0.12

0.02

;0.23

0.02

12mon

ths

-0.01

-0.35;0.34

0.98

0.41

0.06

;0.76

0.03

0.14

-0.30;0.59

0.52

0.30

0.06

;0.55

0.02

-0.09

-0.41;0.24

0.58

0.07

-0.30;0.45

0.69

Abbreviatio

ns:F-ACT:FlexibleAssertiveCom

mun

ityTreatmen

t,F-AC

Tteam

soffe

rcom

mun

ity-dwellin

gpa

tientsc

areinth

eiro

wnlivingen

vironm

ent.

a The

con

trolgroup

isth

ereferencegrou

p.b G

roup

xtime.