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Forbedre hjerte og metabolsk helse hos personer med alvorlig psykisk sykdom gjennom en langsiktig klinisk prøve (LAGOM)

6. august 2026 oppdatert av: Vastra Gotaland Region

Langsgående tilnærming for å generere positive kardiometabolske helseutfall ved alvorlig psykisk sykdom

Kardiometabolske sykdommer er utbredt blant individer med psykotiske lidelser, noe som i betydelig grad bidrar til deres kortere levetid, redusert livskvalitet og økonomisk innvirkning på individer og samfunn. For å forbedre kardiometabolsk helse er effektive og individualiserte intervensjoner avgjørende. Psykosepoliklinikker er ideelle for disse intervensjonene på grunn av regelmessige pasientbesøk og tilgjengeligheten av ulike helsepersonell. Etterforskerne har utviklet og ønsker å teste et omfattende intervensjonsprogram for å forbedre kardiometabolsk helse, øke livskvaliteten og fremme sunn livsstil spesielt for personer med psykotiske lidelser ved psykiatriske poliklinikker i Gøteborg.

Denne kliniske studien tar sikte på å inkludere 644 personer med psykotiske lidelser fra seks poliklinikker ved avdelingen for psykotiske lidelser ved Sahlgrenska universitetssykehuset i Gøteborg. To poliklinikker vil gi LAGOM-intervensjonen, mens de andre klinikkene vil fungere som kontroller, og tilby "pleie som vanlig". Intervensjonsgruppen vil motta multidisiplinær støtte integrert i de rutinemessige kliniske prosedyrene. Intervensjonen inkluderer regelmessige oppfølginger og bruk av motivasjonsverktøy, inkludert kroppssammensetningsanalysator og kardiovaskulær risikoprediksjonsalgoritme (QRISK3).

Hvis intervensjonen effektivt forbedrer kardiometabolsk helse, øker livskvaliteten for denne sårbare gruppen og viser seg kostnadseffektiv, kan den tjene som et modellprogram for implementering i Västra Götalandsregionen.

Studieoversikt

Status

Rekruttering

Forhold

Psykotiske lidelser

Intervensjon / Behandling

Annen: Innblanding

Studietype

Intervensjonell

Registrering (Antatt)

650

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Hemen Najar, M.D., Ph.D.
Telefonnummer: 0046 73 566 15 64
E-post: hemen.najar@vgregion.se

Studiesteder

Sverige
- - Gothenburg, Sverige, 411 13
    - Rekruttering
    - Psykosmottagning Centrum
    - Ta kontakt med:
      
      Eva Andreasson
      
      Telefonnummer: 0046 70 242 67 97
      
      E-post: evaandreasson17@gmail.com
    - Hovedetterforsker:
      
      Eva Andreasson
  - Gothenburg, Sverige, 417 52
    - Rekruttering
    - Psykosmottagning Hisingen
    - Ta kontakt med:
      
      Christina Hagberg
      
      Telefonnummer: 0046 73 660 14 18
      
      E-post: christina.i.hagberg@vgregion.se
    - Hovedetterforsker:
      
      Christina Hagberg
  - Gothenburg, Sverige, 421 48
    - Rekruttering
    - Psykosmottagning Väster
    - Ta kontakt med:
      
      Caroline Holmbom
      
      Telefonnummer: 0046 76 949 43 08
      
      E-post: caroline.e.larsson@vgregion.se
    - Hovedetterforsker:
      
      Caroline Holmbom
  - Gothenburg, Sverige, 415 05
    - Rekruttering
    - Psykosmottagning Nordost
    - Ta kontakt med:
      
      Elin Saari-Bladmyr
      
      Telefonnummer: 0046 70 355 13 57
      
      E-post: elin.bladmyr@vgregion.se
    - Hovedetterforsker:
      
      Elin Saari-Bladmyr
  - Gothenburg, Sverige, 416 72
    - Rekruttering
    - Psykosmottagning Öster
    - Ta kontakt med:
      
      Lina Klysing
      
      Telefonnummer: 0046 72 145 83 73
      
      E-post: lina.persson@vgregion.se
    - Hovedetterforsker:
      
      Lina Klysing
  - Mölndal, Sverige, 431 35
    - Rekruttering
    - Psykosmottagning Mölndal
    - Ta kontakt med:
      
      Erik Wålinder
      
      Telefonnummer: 0046 76 940 29 76
      
      E-post: erik.walinder@vgregion.se
    - Hovedetterforsker:
      
      Erik Wålinder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inkluderingskriterier:

Voksne, ≥18 år, som oppfyller ICD-10 diagnostiske kriterier for en hvilken som helst av lidelsene i schizofrenispekteret (F20-F25 eller F28-F29).
Har muligheten til å signere informert samtykke.

Ekskluderingskriterier:

Å ha et elektrisk medisinsk implantat som pacemaker eller andre mekaniske implantater.
Gravide kvinner.
Anses som uegnet for inkludering etter etterforskerens skjønn.
Tidligere deltagelse i den kliniske studien.
Under behandling med tvungen omsorg.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Forebygging
Tildeling: Ikke-randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Ingen inngripen: Kontrollklinikker (vanlig behandling) Den "vanlige behandlings"-modellen i Göteborg inkluderer årlige helsesjekker for personer med psykotiske lidelser. Pasienter gjennomgår to 60-minutters besøk for vurderinger som blodprøver, blodtrykksmålinger og vektkontroller, med resultater evaluert ved bruk av standard referanseverdier eller risikokalkulatorer som SCORE2. Lege kan foreslå henvisning til primærhelsetjenesten eller anbefale livsstilsendringer, inkludert kosthold, trening eller justeringer av rusmiddelbruk. Identifiserte problemer kan føre til enkle råd eller henvisning til helsefremmere for støtte ved røykeslutt, kostholdsveiledning eller gruppeaktiviteter. Den 36 ± 6 måneders kliniske studien standardiserer datainnsamling ved fire poliklinikker uten å endre behandlingen. Kvalifiserte pasienter signerer samtykke, med gjenoppscreening tillatt hvis en pasient oppfyller eksklusjonskriteriene ved en årlig sjekk, men ikke ved den neste. Ikke-deltakere fortsetter med vanlig behandling.
Eksperimentell: Intervensjonsklinikker De årlige helsesjekkene for intervensjonsgruppen følger samme struktur med to besøk som i rutinemessig omsorg som vanlig, med den primære forskjellen å være innholdet i besøkene.	Annen: Innblanding Intervensjonsgruppen følger et strukturert flytskjema for årlige helsesjekker, med fokus på vurdering av kardiometabolsk profil, med tanke på kjønn og etnisitet. Denne vurderingen inkluderer sporing av endringer i kardiometabolske parametere, sammen med generell kardiometabolsk risiko ved bruk av SCORE2 og om kriteriene for metabolsk syndrom er oppfylt. Livsstilsvaner blir evaluert basert på helsestatus, sykdom og fordelene ved å slutte med usunn atferd. Utdanningsøkter utdanner deltakere og familier om sammenhengen mellom psykotiske lidelser, livsstilsvalg og kardiometabolsk helse. Gradvise livsstilsendringer er skreddersydd til individuelle behov, adresserer stress og kognitive utfordringer, og følger nasjonale helseretningslinjer med personlig tilpassede råd og motivasjonsverktøy. Regelmessige oppfølginger vurderer fremgang, mens motiverende verktøy «kroppssammensetningsanalysator og QRISK3» øker engasjementet. Kontakt med interne og eksterne ressurser er basert på vurderings- og motivasjonsarbeidet.

Deltakergruppe / Arm

Intervensjon / Behandling

Ingen inngripen: Kontrollklinikker (vanlig behandling)

Den "vanlige behandlings"-modellen i Göteborg inkluderer årlige helsesjekker for personer med psykotiske lidelser. Pasienter gjennomgår to 60-minutters besøk for vurderinger som blodprøver, blodtrykksmålinger og vektkontroller, med resultater evaluert ved bruk av standard referanseverdier eller risikokalkulatorer som SCORE2. Lege kan foreslå henvisning til primærhelsetjenesten eller anbefale livsstilsendringer, inkludert kosthold, trening eller justeringer av rusmiddelbruk. Identifiserte problemer kan føre til enkle råd eller henvisning til helsefremmere for støtte ved røykeslutt, kostholdsveiledning eller gruppeaktiviteter.

Den 36 ± 6 måneders kliniske studien standardiserer datainnsamling ved fire poliklinikker uten å endre behandlingen. Kvalifiserte pasienter signerer samtykke, med gjenoppscreening tillatt hvis en pasient oppfyller eksklusjonskriteriene ved en årlig sjekk, men ikke ved den neste. Ikke-deltakere fortsetter med vanlig behandling.

Eksperimentell: Intervensjonsklinikker

De årlige helsesjekkene for intervensjonsgruppen følger samme struktur med to besøk som i rutinemessig omsorg som vanlig, med den primære forskjellen å være innholdet i besøkene.

Annen: Innblanding

Intervensjonsgruppen følger et strukturert flytskjema for årlige helsesjekker, med fokus på vurdering av kardiometabolsk profil, med tanke på kjønn og etnisitet. Denne vurderingen inkluderer sporing av endringer i kardiometabolske parametere, sammen med generell kardiometabolsk risiko ved bruk av SCORE2 og om kriteriene for metabolsk syndrom er oppfylt.

Livsstilsvaner blir evaluert basert på helsestatus, sykdom og fordelene ved å slutte med usunn atferd. Utdanningsøkter utdanner deltakere og familier om sammenhengen mellom psykotiske lidelser, livsstilsvalg og kardiometabolsk helse.

Gradvise livsstilsendringer er skreddersydd til individuelle behov, adresserer stress og kognitive utfordringer, og følger nasjonale helseretningslinjer med personlig tilpassede råd og motivasjonsverktøy. Regelmessige oppfølginger vurderer fremgang, mens motiverende verktøy «kroppssammensetningsanalysator og QRISK3» øker engasjementet. Kontakt med interne og eksterne ressurser er basert på vurderings- og motivasjonsarbeidet.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm Tidsramme: At 12 months from baseline.	Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.	At 12 months from baseline.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm Tidsramme: At 24 months from baseline.	Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.	At 24 months from baseline.
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm Tidsramme: At 36 months from baseline.	Whether the intervention is superior to usual care in reducing the estimated absolute ten-year cardiovascular risk, assessed at 12, 24, and 36 months. Primary endpoint: The difference between the intervention and control groups in the mean change in estimated absolute cardiovascular risk, as assessed using the Systematic COronary Risk Evaluation 2 (SCORE2), a tool designed to estimate the 10-year risk of cardiovascular events in individuals aged 40-89 years. SCORE2 ranges from a minimum value of 0% (indicating no risk) to a maximum value of 100% (indicating certainty of an event). Higher scores represent a worse outcome, as they reflect an increased likelihood of experiencing a cardiovascular event within the specified timeframe.	At 36 months from baseline.

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in body mass index Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).	At 12 months from baseline.
Change in body mass index Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).	At 24 months from baseline.
Change in body mass index Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in body mass index (BMI) (kg/m2).	At 36 months from baseline.
Change in waist-hip ratio Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR).	At 12 months from baseline.
Change in waist-hip ratio Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR).	At 24 months from baseline.
Change in waist-hip ratio Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in waist-hip ratio (WHR).	At 36 months from baseline.
Change in systolic blood pressure Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg).	At 12 months from baseline.
Change in systolic blood pressure Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg).	At 24 months from baseline.
Change in systolic blood pressure Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in systolic blood pressure (SBP) (mm Hg).	At 36 months from baseline.
Change in diastolic blood pressure Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg.	At 12 months from baseline.
Change in diastolic blood pressure Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg.	At 24 months from baseline.
Change in diastolic blood pressure Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in diastolic blood pressure (DBP) mm Hg.	At 36 months from baseline.
Change in plasma glucose Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L).	At 12 months from baseline.
Change in plasma glucose Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L).	At 24 months from baseline.
Change in plasma glucose Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in plasma glucose (mmol/L).	At 36 months from baseline.
Change in total cholesterol/HDL-C ratio Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 12 months from baseline.
Change in total cholesterol/HDL-C ratio Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 24 months from baseline.
Change in total cholesterol/HDL-C ratio Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in total cholesterol/HDL-C ratio (TChol/HDL-C ratio).	At 36 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 12 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 24 months from baseline.
Change in triacylglycerol/high density lipoprotein-cholesterol ratio Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing cardiometabolic risk indicators at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in triacylglycerol/high density lipoprotein-cholesterol ratio (TAG/HDL-C ratio).	At 36 months from baseline.
Change in cardiovascular disease (CVD) events Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events.	At 12 months from baseline.
Change in cardiovascular disease (CVD) events Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events.	At 24 months from baseline.
Change in cardiovascular disease (CVD) events Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing the risk of cardiovascular disease (CVD) at 12, 24, and 36 months. Secondary endpoint: CVD outcomes: Hazard ratio of incident CVD events.	At 36 months from baseline.
Change in incident rate of type 2 diabetes mellitus events Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.	At 12 months from baseline.
Change in incident rate of type 2 diabetes mellitus events Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.	At 24 months from baseline.
Change in incident rate of type 2 diabetes mellitus events Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing type 2 diabetes mellitus at 36 months. Secondary endpoint: Diabetes mellitus outcomes: Hazard ratio of incident type 2 diabetes mellitus events.	At 36 months from baseline.
Change in quality of life Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life). Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 12 months from baseline.
Change in quality of life Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life). Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 24 months from baseline.
Change in quality of life Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in improving health-related quality of life at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in the EQ-5D-5L score (quality of life). Quality of life according to the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire, which measures five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents indicate problems on each dimension at one of five levels: no problems, slight problems, moderate problems, severe problems, or extreme problems/unable to perform. The EQ-5D-5L classification system can describe 3,125 possible health states. Additionally, the EQ-5D-5L includes a visual analogue scale (EQ VAS), where respondents rate their current health on a scale from 0 (the worst health they can imagine) to 100 (the best health they can imagine).	At 36 months from baseline.
Change in high-sensitivity C-reactive protein Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L).	At 12 months from baseline.
Change in high-sensitivity C-reactive protein Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L).	At 24 months from baseline.
Change in high-sensitivity C-reactive protein Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of high-sensitivity C-reactive protein (hs-CRP) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in hs-CRP (mg/L).	At 36 months from baseline.
Change in HbA1c Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol).	At 12 months from baseline.
Change in HbA1c Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol).	At 24 months from baseline.
Change in HbA1c Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in reducing the levels of HbA1c at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in HbA1c (mmol/mol).	At 36 months from baseline.
Descriptive cost analysis Tidsramme: At 12 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 12 months from baseline.
Descriptive cost analysis Tidsramme: At 24 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 24 months from baseline.
Descriptive cost analysis Tidsramme: At 36 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Descriptive cost analysis (average cost per participant) in SEK and EUR.	At 36 months from baseline.
Change in quality-Adjusted Life Years Tidsramme: At 12 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.	At 12 months from baseline.
Change in quality-Adjusted Life Years Tidsramme: At 24 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.	At 24 months from baseline.
Change in quality-Adjusted Life Years Tidsramme: At 36 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Difference in the mean change in quality-adjusted life years (QALYs) between the intervention and control groups.	At 36 months from baseline.
Incremental cost-effectiveness ratio based on CVD Tidsramme: At 12 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on CVD Tidsramme: At 24 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on CVD Tidsramme: At 36 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of CVD or type 2 diabetes mellitus cases averted and the number of QALYs gained.	At 36 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus Tidsramme: At 12 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus Tidsramme: At 24 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on type 2 diabetes mellitus Tidsramme: At 36 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of type 2 diabetes mellitus cases averted.	At 36 months from baseline.
Incremental cost-effectiveness ratio based on QALYs Tidsramme: At 12 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 12 months from baseline.
Incremental cost-effectiveness ratio based on QALYs Tidsramme: At 24 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 24 months from baseline.
Incremental cost-effectiveness ratio based on QALYs Tidsramme: At 36 months from baseline.	To assess cost per participant and cost-effectiveness at 12, 24, and 36 months, where cost neutrality is considered a positive outcome. Secondary endpoint: Incremental cost-effectiveness ratio (ICER) based on the number of QALYs gained.	At 36 months from baseline.
Change in alcohol consumption Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), scale 0-12). The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 12 months from baseline.
Change in alcohol consumption Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), scale 0-12). The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 24 months from baseline.
Change in alcohol consumption Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in alcohol consumption (Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), scale 0-12). The AUDIT-C (Alcohol Use Disorders Identification Test-Consumption) is a brief screening tool consisting of three questions, with scores ranging from 0 to 12 points, used to identify risky alcohol use and potential alcohol use disorders.	At 36 months from baseline.
Change in tobacco smoking Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 12 months from baseline.
Change in tobacco smoking Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 24 months from baseline.
Change in tobacco smoking Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in tobacco smoking* per week. *The tobacco smoking questionnaire assesses smoking behavior with targeted questions addressing current smoking status, past smoking history, age at smoking initiation or cessation, and smoking frequency (daily or weekly cigarette consumption). For smoking frequency: Daily smoking frequency: Minimum = 0 cigarettes/day; Maximum = unlimited (as self-reported by participants). Weekly smoking frequency: Minimum = 0 cigarettes/week; Maximum = unlimited (as self-reported by participants). Higher values for daily or weekly smoking frequency indicate worse outcomes (greater tobacco use).	At 36 months from baseline.
Change in dietary habits Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 12 months from baseline.
Change in dietary habits Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 24 months from baseline.
Change in dietary habits Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in dietary habits (dietary index)* (scale 0-12). *The dietary habits questionnaire (Kostindex) assesses dietary patterns through questions on vegetable, fruit, fish, sweets, and breakfast consumption. Scores range from 0 to 12, categorizing habits as unhealthy, moderate, or healthy to guide nutritional advice.	At 36 months from baseline.
Change in physical activity Tidsramme: At 12 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 12 months from baseline.
Change in physical activity Tidsramme: At 24 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 24 months from baseline.
Change in physical activity Tidsramme: At 36 months from baseline.	To assess whether the intervention is superior to usual care in improving targeted lifestyle behaviors (tobacco smoking, alcohol consumption, physical activity, and dietary habits) at 12, 24, and 36 months. Secondary endpoint: Difference in the mean change in physical activity* (number of minutes per day). *The physical activity and inactivity questionnaire evaluates daily habits by measuring time spent on everyday activities, exercise, and sedentary time, including sleep. For physical activity: Higher values indicate better outcomes (more active time). For sedentary time: Higher values indicate worse outcomes (more inactive time).	At 36 months from baseline.

Andre resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Requirements for achieving a change in targeted lifestyle Tidsramme: At 12 months from baseline.	To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 12 months from baseline.
Requirements for achieving a change in targeted lifestyle Tidsramme: At 24 months from baseline.	To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 24 months from baseline.
Requirements for achieving a change in targeted lifestyle Tidsramme: At 36 months from baseline.	To assess how the number, type, and average interval between lifestyle-focused intervention sessions are associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 36 months from baseline.
Effect of educational sessions Tidsramme: At 12 months from baseline.	To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 12 months from baseline.
Effect of educational sessions Tidsramme: At 24 months from baseline.	To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 24 months from baseline.
Effect of educational sessions Tidsramme: At 36 months from baseline.	To assess whether participation in educational sessions (0-3 sessions) by participants and their relatives is associated with changes in lifestyle outcomes at 12, 24, and 36 months within the intervention group to examine factors related to engagement with the intervention.	At 36 months from baseline.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vastra Gotaland Region

Samarbeidspartnere

The Swedish Society of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Najar H, Jedenius E, Froberg A, Olofsson A, Holmbom C, Bjorlin CK, Hagberg C, Saari-Bladmyr E, Hantelius E, Walinder E, Andreasson E, Gustafsson J, Lundin L, Klysing L, Rundqvist L, Korvek N, Rydell P, Heder S, Zeebari Z, Holmberg C. Multicenter, cluster-based, superiority trial of a multicomponent lifestyle intervention versus usual care for reducing cardiometabolic risk in individuals with psychotic disorders over 36 months: the LAGOM protocol. BMC Psychiatry. 2026 Jun 23;26(1):487. doi: 10.1186/s12888-026-08315-3.

Hjelpsomme linker

The published study protocol

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. februar 2025

Primær fullføring (Antatt)

31. desember 2029

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

2. januar 2025

Først innsendt som oppfylte QC-kriteriene

13. januar 2025

Først lagt ut (Faktiske)

17. januar 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. august 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CIV-24-09-049056

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

I henhold til den svenske offentlighets- og sekretesloven kan ikke data på individnivå være offentlig tilgjengelig.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Forbedre hjerte og metabolsk helse hos personer med alvorlig psykisk sykdom gjennom en langsiktig klinisk prøve (LAGOM)

Langsgående tilnærming for å generere positive kardiometabolske helseutfall ved alvorlig psykisk sykdom

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Andre resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Samarbeidspartnere

Publikasjoner og nyttige lenker

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt