Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients

NCT07157813 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

  • Forensic Psychiatric Patients
  • Cardio Vascular Disease
  • Health Promotion
  • Forensic Mental Health
  • Forensic Psychiatry
  • Physical Fittness
  • Diet Habits
  • Smoking Cessation

Interventions

BEHAVIORAL

Structured Health Dialogue

In addition to usual care, participants take part in two nurse-led Structured Health Dialogue (SHD) sessions at baseline and 12 months. The results from the measurements and questionnaires are integrated into an individualized visual risk profile ("health curve"). This profile is used as the foundation for a 60-90 minute dialogue, guided by motivational interviewing principles, to enhance risk awareness, promote self-reflection, and support participants in setting achievable goals for lifestyle improvement.

Sponsors & Collaborators

  • Lund University

    collaborator OTHER
  • Kronoberg County Council

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07157813 on ClinicalTrials.gov