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Améliorer la santé cardiaque et métabolique des personnes atteintes d'une maladie mentale grave grâce à un essai clinique à long terme (LAGOM)

6 août 2026 mis à jour par: Vastra Gotaland Region

Approche longitudinale pour générer des résultats cardiométaboliques positifs en matière de santé mentale grave

Les maladies cardiométaboliques sont répandues chez les personnes atteintes de troubles psychotiques, contribuant de manière significative à leur espérance de vie plus courte, à leur qualité de vie réduite et à leur impact économique sur les individus et la société. Pour améliorer la santé cardiométabolique, des interventions efficaces et individualisées sont cruciales. Les cliniques externes de psychose sont idéales pour ces interventions en raison des visites régulières des patients et de la disponibilité de divers professionnels de la santé. Les enquêteurs ont développé et souhaitent tester un programme d'intervention complet pour améliorer la santé cardiométabolique, améliorer la qualité de vie et promouvoir des modes de vie sains spécifiquement pour les personnes souffrant de troubles psychotiques dans les cliniques psychiatriques ambulatoires de Göteborg.

Cet essai clinique vise à inclure 644 personnes atteintes de troubles psychotiques provenant de six cliniques externes du département des troubles psychotiques de l'hôpital universitaire Sahlgrenska de Göteborg. Deux cliniques ambulatoires assureront l'intervention LAGOM, tandis que les autres cliniques serviront de contrôles, offrant « des soins comme d'habitude ». Le groupe d'intervention recevra un soutien multidisciplinaire intégré aux procédures cliniques de routine. L'intervention comprend des suivis réguliers et l'utilisation d'outils de motivation, notamment un analyseur de composition corporelle et un algorithme de prédiction du risque cardiovasculaire (QRISK3).

Si l'intervention améliore efficacement la santé cardiométabolique, améliore la qualité de vie de ce groupe vulnérable et s'avère rentable, elle peut servir de programme modèle à mettre en œuvre dans la région Västra Götaland.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Troubles psychotiques

Intervention / Traitement

Autre: Intervention

Type d'étude

Interventionnel

Inscription (Estimé)

650

Phase

N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Hemen Najar, M.D., Ph.D.
Numéro de téléphone: 0046 73 566 15 64
E-mail: hemen.najar@vgregion.se

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critères d'intégration :

Adultes de ≥ 18 ans répondant aux critères diagnostiques de la CIM-10 pour l'un des troubles du spectre de la schizophrénie (F20-F25 ou F28-F29).
A la capacité de signer un consentement éclairé.

Critères d'exclusion :

Avoir un implant médical électrique comme un stimulateur cardiaque ou d'autres implants mécaniques.
Les femmes enceintes.
Considéré comme impropre à l'inclusion à la discrétion de l'enquêteur.
Participation antérieure à l'essai clinique.
Sous traitement avec soins obligatoires.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: La prévention
Répartition: Non randomisé
Modèle interventionnel: Affectation parallèle
Masquage: Aucun (étiquette ouverte)

Nombre de bras

Armes et Interventions

Groupe de participants / Bras	Intervention / Traitement
Aucune intervention: Cliniques de contrôle (soins habituels) Le modèle de "soins habituels" à Göteborg inclut des bilans de santé annuels pour les personnes atteintes de troubles psychotiques. Les patients assistent à deux visites de 60 minutes pour des évaluations telles que des analyses sanguines, la mesure de la pression artérielle et des contrôles de poids, les résultats étant évalués à l'aide de références standard ou d'algorithmes de risque comme SCORE2. Les médecins peuvent suggérer des orientations vers les soins primaires ou recommander des changements de mode de vie, y compris des ajustements alimentaires, de l'exercice ou des modifications de la consommation de substances. Les problèmes identifiés peuvent donner lieu à des conseils simples ou à des orientations vers des promoteurs de santé pour un soutien en matière de sevrage tabagique, de conseils alimentaires ou d'activités de groupe. L'essai clinique de 36 ± 6 mois standardise la collecte de données dans quatre cliniques ambulatoires sans modifier les soins. Les patients éligibles signent un consentement, avec une possibilité de resélection si un patient répond aux critères d'exclusion lors d'un bilan annuel mais pas au suivant. Les non-participants continuent de recevoir les soins habituels.
Expérimental: Cliniques d'Intervention Les bilans de santé annuels pour le groupe d'intervention suivent la même structure de deux visites que dans les soins de routine habituels, la principale différence étant le contenu des visites.	Autre: Intervention Le groupe d'intervention suit un organigramme structuré pour les bilans de santé annuels, axés sur l'évaluation du profil cardiométabolique, en tenant compte du sexe et de l'origine ethnique. Cette évaluation comprend le suivi des modifications des paramètres cardiométaboliques, ainsi que du risque cardiométabolique global à l'aide de SCORE2 et si les critères du syndrome métabolique sont remplis. Les habitudes de vie sont évaluées en fonction de l'état de santé, de la maladie et des avantages de l'abandon des comportements malsains. Les séances éducatives sensibilisent les participants et les familles au lien entre les troubles psychotiques, les choix de mode de vie et la santé cardiométabolique. Les changements progressifs de style de vie sont adaptés aux besoins individuels, répondent au stress et aux défis cognitifs, et suivent les directives nationales de santé avec des conseils personnalisés et des outils de motivation. Des suivis réguliers évaluent les progrès, tandis que les outils de motivation « analyseur de composition corporelle et QRISK3 » améliorent l'engagement. Le contact avec les ressources internes et externes s'appuie sur le travail d'évaluation et de motivation.

Groupe de participants / Bras

Intervention / Traitement

Aucune intervention: Cliniques de contrôle (soins habituels)

Le modèle de "soins habituels" à Göteborg inclut des bilans de santé annuels pour les personnes atteintes de troubles psychotiques. Les patients assistent à deux visites de 60 minutes pour des évaluations telles que des analyses sanguines, la mesure de la pression artérielle et des contrôles de poids, les résultats étant évalués à l'aide de références standard ou d'algorithmes de risque comme SCORE2. Les médecins peuvent suggérer des orientations vers les soins primaires ou recommander des changements de mode de vie, y compris des ajustements alimentaires, de l'exercice ou des modifications de la consommation de substances. Les problèmes identifiés peuvent donner lieu à des conseils simples ou à des orientations vers des promoteurs de santé pour un soutien en matière de sevrage tabagique, de conseils alimentaires ou d'activités de groupe.

L'essai clinique de 36 ± 6 mois standardise la collecte de données dans quatre cliniques ambulatoires sans modifier les soins. Les patients éligibles signent un consentement, avec une possibilité de resélection si un patient répond aux critères d'exclusion lors d'un bilan annuel mais pas au suivant. Les non-participants continuent de recevoir les soins habituels.

Expérimental: Cliniques d'Intervention

Les bilans de santé annuels pour le groupe d'intervention suivent la même structure de deux visites que dans les soins de routine habituels, la principale différence étant le contenu des visites.

Autre: Intervention

Le groupe d'intervention suit un organigramme structuré pour les bilans de santé annuels, axés sur l'évaluation du profil cardiométabolique, en tenant compte du sexe et de l'origine ethnique. Cette évaluation comprend le suivi des modifications des paramètres cardiométaboliques, ainsi que du risque cardiométabolique global à l'aide de SCORE2 et si les critères du syndrome métabolique sont remplis.

Les habitudes de vie sont évaluées en fonction de l'état de santé, de la maladie et des avantages de l'abandon des comportements malsains. Les séances éducatives sensibilisent les participants et les familles au lien entre les troubles psychotiques, les choix de mode de vie et la santé cardiométabolique.

Les changements progressifs de style de vie sont adaptés aux besoins individuels, répondent au stress et aux défis cognitifs, et suivent les directives nationales de santé avec des conseils personnalisés et des outils de motivation. Des suivis réguliers évaluent les progrès, tandis que les outils de motivation « analyseur de composition corporelle et QRISK3 » améliorent l'engagement. Le contact avec les ressources internes et externes s'appuie sur le travail d'évaluation et de motivation.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Estimated absolute ten-year cardiovascular risk based on the SCORE2 algorithm Délai: 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 Délai: 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 Délai: 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.

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Change in body mass index Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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.

Autres mesures de résultats

Mesure des résultats	Description de la mesure	Délai
Requirements for achieving a change in targeted lifestyle Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vastra Gotaland Region

Collaborateurs

The Swedish Society of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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.

Liens utiles

The published study protocol

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

27 février 2025

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

2 janvier 2025

Première soumission répondant aux critères de contrôle qualité

13 janvier 2025

Première publication (Réel)

17 janvier 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

11 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 août 2026

Dernière vérification

1 octobre 2025

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

CIV-24-09-049056

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Conformément à la loi suédoise sur l'accès public à l'information et le secret, les données individuelles ne peuvent pas être accessibles au public.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Améliorer la santé cardiaque et métabolique des personnes atteintes d'une maladie mentale grave grâce à un essai clinique à long terme (LAGOM)

Approche longitudinale pour générer des résultats cardiométaboliques positifs en matière de santé mentale grave

Aperçu de l'étude

Statut

Les conditions

Intervention / Traitement

Type d'étude

Inscription (Estimé)

Phase

Contacts et emplacements

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Critère d'éligibilité

Âges éligibles pour étudier

Accepte les volontaires sains

La description

Plan d'étude

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de bras

Armes et Interventions

Groupe de participants / Bras

Intervention / Traitement

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats

Description de la mesure

Délai

Mesures de résultats secondaires

Mesure des résultats

Description de la mesure

Délai

Autres mesures de résultats

Mesure des résultats

Description de la mesure

Délai

Collaborateurs et enquêteurs

Parrainer

Collaborateurs

Publications et liens utiles

Publications générales

Liens utiles

Dates d'enregistrement des études

Dates principales de l'étude

Début de l'étude (Réel)

Achèvement primaire (Estimé)

Achèvement de l'étude (Estimé)

Dates d'inscription aux études

Première soumission

Première soumission répondant aux critères de contrôle qualité

Première publication (Réel)

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

Dernière mise à jour soumise répondant aux critères de contrôle qualité

Dernière vérification

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Description du régime IPD

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Étudie un produit d'appareil réglementé par la FDA américaine