Clinical Trial

Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients

Study acronym: FOR-HEALTH
Enrolling by Invitation
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Summary
Background:People in compulsory forensic psychiatric care experience high rates of metabolic syndrome, cardiovascular disease, and related lifestyle risk factors, yet structured preventive health interventions are uncommon in secure psychiatric settings. The Structured Health Dialogue (SHD), a Swedish primary care model for cardiovascular disease prevention, combines motivational interviewing with individualised risk assessment and tailored lifestyle advice. Objective:To evaluate the feasibility, acceptability, and preliminary effects of an adapted SHD intervention in forensic psychiatric inpatient care. Methods:This single-centre, parallel-group, randomized controlled feasibility trial will recruit 50 adults aged 18-64 years from a secure forensic psychiatric clinic in Sweden. Participants will be randomized (1:1) to SHD plus usual care or usual care alone. The SHD includes health screening, lifestyle assessment, personalised cardiovascular risk feedback, and tailored recommendations. Primary outcomes are recruitment, retention, dropout, and assessment completion rates. Secondary outcomes include changes in metabolic risk factors and patient-reported quality of life and functioning (EQ-5D-5L, Mental Fatigue Scale) from baseline to 12 months. Conclusion: This study will inform the feasibility and potential effectiveness of implementing structured, person-centred preventive health interventions in forensic psychiatric care, guiding the design of a future full-scale trial.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-28; most recent amendment 2026-06-01.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-06-01
Trial Details
NCT Number NCT07157813
Lead Sponsor Kronoberg County Council
Collaborators: Lund University
Conditions Forensic Psychiatric Patients, Cardio Vascular Disease, Health Promotion, Forensic Mental Health, Forensic Psychiatry, Physical Fittness, Diet Habits, Smoking Cessation
Enrollment 50 participants
Start Date 2026-03-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-03