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Forbedring af hjerte og metabolisk sundhed hos mennesker med alvorlig psykisk sygdom gennem et langsigtet klinisk forsøg (LAGOM)

6. august 2026 opdateret af: Vastra Gotaland Region

Langsgående tilgang til at skabe positive kardiometaboliske sundhedsresultater ved svær psykisk sygdom

Kardiometaboliske sygdomme er udbredt blandt personer med psykotiske lidelser, hvilket i væsentlig grad bidrager til deres kortere levetid, nedsat livskvalitet og økonomiske konsekvenser for individer og samfund. For at forbedre kardiometabolisk sundhed er effektive og individualiserede interventioner afgørende. Psykoseambulatorier er ideelle til disse interventioner på grund af regelmæssige patientbesøg og tilgængeligheden af forskellige sundhedsprofessionelle. Efterforskerne har udviklet og ønsker at teste et omfattende interventionsprogram for at forbedre kardiometabolisk sundhed, øge livskvaliteten og fremme sund livsstil specifikt for mennesker med psykotiske lidelser på psykiatriske ambulatorier i Gøteborg.

Dette kliniske forsøg sigter mod at inkludere 644 personer med psykotiske lidelser fra seks ambulatorier i Afdelingen for Psykotiske Lidelser på Sahlgrenska Universitetshospitalet i Gøteborg. To ambulatorier vil stå for LAGOM-interventionen, mens de øvrige klinikker vil fungere som kontroller, der tilbyder "care as usual". Interventionsgruppen vil modtage tværfaglig støtte integreret i de rutinemæssige kliniske procedurer. Interventionen omfatter regelmæssige opfølgninger og brug af motiverende værktøjer, herunder kropssammensætningsanalysator og kardiovaskulær risikoforudsigelsesalgoritme (QRISK3).

Hvis interventionen effektivt forbedrer kardiometabolisk sundhed, forbedrer livskvaliteten for denne sårbare gruppe og viser sig omkostningseffektiv, kan den tjene som et modelprogram for implementering i Region Västra Götaland.

Studieoversigt

Status

Rekruttering

Betingelser

Psykotiske lidelser

Intervention / Behandling

Andet: Intervention

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

650

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

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

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Voksne, ≥18 år, der opfylder ICD-10 diagnostiske kriterier for en hvilken som helst af skizofrenispektrumlidelserne (F20-F25 eller F28-F29).
Har mulighed for at underskrive informeret samtykke.

Ekskluderingskriterier:

At have et elektrisk medicinsk implantat som pacemaker eller andre mekaniske implantater.
Gravide kvinder.
Anses for uegnet til optagelse efter efterforskerens skøn.
Tidligere deltagelse i det kliniske forsøg.
Under behandling med tvangspleje.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Ikke-randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Ingen indgriben: Kontrolklinikker (sædvanlig behandling) Den "sædvanlige pleje"-model i Göteborg omfatter årlige helbredstjek for personer med psykotiske lidelser. Patienter deltager i to 60-minutters besøg til vurderinger som blodprøver, blodtryksmålinger og vægtkontroller, med resultater vurderet ved hjælp af standardbenchmarks eller risikolgoritmer som SCORE2. Læger kan foreslå henvisninger til primærpleje eller anbefale livsstilsændringer, herunder kost, motion eller justeringer af stofbrug. Identificerede problemer kan føre til enkle råd eller henvisninger til sundhedsfremmere for støtte til rygestop, kostvejledning eller gruppeaktiviteter. Det 36 ± 6-måneders kliniske forsøg standardiserer dataindsamling på fire ambulante klinikker uden at ændre på plejen. Berettigede patienter underskriver samtykke, med genundersøgelse tilladt, hvis en patient opfylder eksklusionskriterierne ved ét årligt tjek, men ikke ved det næste. Ikke-deltagere fortsætter med almindelig pleje.
Eksperimentel: Interventionsklinikker De årlige sundhedskontroller for interventionsgruppen følger den samme struktur med to besøg som i den sædvanlige rutinemæssige pleje, med den primære forskel at indholdet i besøgene er anderledes.	Andet: Intervention Interventionsgruppen følger et struktureret flowchart for årlige helbredstjek, med fokus på vurdering af den kardiometaboliske profil med hensyn til køn og etnicitet. Denne vurdering omfatter sporing af ændringer i kardiometaboliske parametre sammen med den overordnede kardiometaboliske risiko ved brug af SCORE2, og hvis kriterierne for metabolisk syndrom er opfyldt. Livsstilsvaner vurderes ud fra sundhedstilstand, sygdom og fordele ved at holde op med usund adfærd. Uddannelsessessioner uddanner deltagere og familier om sammenhængen mellem psykotiske lidelser, livsstilsvalg og kardiometabolisk sundhed. Gradvise livsstilsændringer er skræddersyet til individuelle behov, adresserer stress og kognitive udfordringer og følger nationale sundhedsretningslinjer med personlig rådgivning og motiverende værktøjer. Regelmæssige opfølgninger vurderer fremskridt, mens motiverende værktøjer "kropssammensætningsanalysator og QRISK3" øger engagementet. Kontakt til interne og eksterne ressourcer tager udgangspunkt i vurderingen og motivationsarbejdet.

Deltagergruppe / Arm

Intervention / Behandling

Ingen indgriben: Kontrolklinikker (sædvanlig behandling)

Den "sædvanlige pleje"-model i Göteborg omfatter årlige helbredstjek for personer med psykotiske lidelser. Patienter deltager i to 60-minutters besøg til vurderinger som blodprøver, blodtryksmålinger og vægtkontroller, med resultater vurderet ved hjælp af standardbenchmarks eller risikolgoritmer som SCORE2. Læger kan foreslå henvisninger til primærpleje eller anbefale livsstilsændringer, herunder kost, motion eller justeringer af stofbrug. Identificerede problemer kan føre til enkle råd eller henvisninger til sundhedsfremmere for støtte til rygestop, kostvejledning eller gruppeaktiviteter.

Det 36 ± 6-måneders kliniske forsøg standardiserer dataindsamling på fire ambulante klinikker uden at ændre på plejen. Berettigede patienter underskriver samtykke, med genundersøgelse tilladt, hvis en patient opfylder eksklusionskriterierne ved ét årligt tjek, men ikke ved det næste. Ikke-deltagere fortsætter med almindelig pleje.

Eksperimentel: Interventionsklinikker

De årlige sundhedskontroller for interventionsgruppen følger den samme struktur med to besøg som i den sædvanlige rutinemæssige pleje, med den primære forskel at indholdet i besøgene er anderledes.

Andet: Intervention

Interventionsgruppen følger et struktureret flowchart for årlige helbredstjek, med fokus på vurdering af den kardiometaboliske profil med hensyn til køn og etnicitet. Denne vurdering omfatter sporing af ændringer i kardiometaboliske parametre sammen med den overordnede kardiometaboliske risiko ved brug af SCORE2, og hvis kriterierne for metabolisk syndrom er opfyldt.

Livsstilsvaner vurderes ud fra sundhedstilstand, sygdom og fordele ved at holde op med usund adfærd. Uddannelsessessioner uddanner deltagere og familier om sammenhængen mellem psykotiske lidelser, livsstilsvalg og kardiometabolisk sundhed.

Gradvise livsstilsændringer er skræddersyet til individuelle behov, adresserer stress og kognitive udfordringer og følger nationale sundhedsretningslinjer med personlig rådgivning og motiverende værktøjer. Regelmæssige opfølgninger vurderer fremskridt, mens motiverende værktøjer "kropssammensætningsanalysator og QRISK3" øger engagementet. Kontakt til interne og eksterne ressourcer tager udgangspunkt i vurderingen og motivationsarbejdet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vastra Gotaland Region

Samarbejdspartnere

The Swedish Society of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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.

Hjælpsomme links

The published study protocol

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. februar 2025

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

2. januar 2025

Først indsendt, der opfyldte QC-kriterier

13. januar 2025

Først opslået (Faktiske)

17. januar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. oktober 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CIV-24-09-049056

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

I henhold til den svenske lov om offentlig adgang til information og sekretess kan data på individuelt niveau ikke være offentligt tilgængelige.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Forbedring af hjerte og metabolisk sundhed hos mennesker med alvorlig psykisk sygdom gennem et langsigtet klinisk forsøg (LAGOM)

Langsgående tilgang til at skabe positive kardiometaboliske sundhedsresultater ved svær psykisk sygdom

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Andre resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt