Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients

NCT07157813 | Not Yet Recruiting

• 2 other identifiers: FOR-HEALTH2025-02066-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Health dialog

Outcome Measures

Primary Outcomes (2)

• Feasibility of the study design and Targeted health dialogue

  Recruitment rate in both groups calculated continuously throughout the recruitment period, reported as the number of participants enrolled per month.

  24-month

• Feasibility of the study design and Targeted health dialogue

  Dropout rate in both groups calculated continuously throughout the study period, reported as the proportion of participants who discontinue participation before completion of follow-up.

  24-month

Secondary Outcomes (13)

• Biometric measures, Body Mass Index (BMI)

  12 months

• Biometric measures, Waist-to-Hip Ratio

  12 months

• Biometric measures, Blood Pressure

  12 months

• Biometric measures, Fasting Plasma Glucose

  12 months

• Biometric measures, Blood Lipid Status

  12 months

Other Outcomes (2)

• Family History of Cardiovascular Disease and Diabetes

  Baseline (single assessment)

• Sociodemographic and Clinical Information

  Baseline (single assessment)

Study Arms (2)

Structured Health Dialogue

EXPERIMENTAL

Participants receive two nurse-led Structured Health Dialogue sessions in addition to usual care. Each session includes a standardized health screening, blood sampling, and physiological measurements, together with a structured discussion tailored to the individual's risk profile. The dialogues and questionnaires are conducted at baseline and at 12 months. At 6 months, only blood sampling, questionnaires and measurements are repeated (no dialogues).

Behavioral: Structured Health Dialogue

Control group

NO INTERVENTION

Participants receive usual care. They undergo blood sampling, physiological measurements, and questionnaires at baseline, 6 months and at 12 months. Participants in the control group do not receive any Structured Health Dialogue sessions.

Interventions

Structured Health Dialogue BEHAVIORAL

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.

Structured Health Dialogue

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18-64 years
• Hospitalized at the forensic psychiatric clinic in Växjö, Sweden.

You may not qualify if:

• Severe language barriers.
• Severe cognitive impairment
• Acute psychiatric states (e.g., suicidality or acute psychosis)
• Aggression hindering safe participation

Sponsors & Collaborators

• Kronoberg County Council: lead
• Lund University: collaborator

Study Sites (1)

Regional Forensic Psychiatric Clinic, Växjö

Vaxjo, Kronoberg County, Sweden

Location

Related Publications (22)

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  PMID: 26685034 BACKGROUND

• Laporte N, Ozolins A, Westling S, Westrin A, Wallinius M. Clinical Characteristics and Self-Harm in Forensic Psychiatric Patients. Front Psychiatry. 2021 Aug 2;12:698372. doi: 10.3389/fpsyt.2021.698372. eCollection 2021.

  PMID: 34408680 BACKGROUND

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• Lingfors H, Persson LG. All-cause mortality among young men 24-26 years after a lifestyle health dialogue in a Swedish primary care setting: a longitudinal follow-up register study. BMJ Open. 2019 Jan 29;9(1):e022474. doi: 10.1136/bmjopen-2018-022474.

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  PMID: 30319459 BACKGROUND

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  PMID: 11491192 BACKGROUND

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  PMID: 20001478 BACKGROUND

• Uhrskov Sorensen L, Bengtson S, Lund J, Ibsen M, Langstrom N. Mortality among male forensic and non-forensic psychiatric patients: matched cohort study of rates, predictors and causes-of-death. Nord J Psychiatry. 2020 Oct;74(7):489-496. doi: 10.1080/08039488.2020.1743753. Epub 2020 Apr 4.

  PMID: 32248726 BACKGROUND

• Dronavalli M, Page A, Ferdousi S, Osaghae M, Sperandei S. Improving metabolic risk in patients with mental illness through 'mental health care plans' in primary health care. Aust N Z J Psychiatry. 2025 Aug;59(8):692-701. doi: 10.1177/00048674251337030. Epub 2025 May 13.

  PMID: 40356373 BACKGROUND

• Vorstenbosch EC, Bouman YH, Braun PC, Bulten EB. Psychometric properties of the forensic inpatient quality of life questionnaire: quality of life assessment for long-term forensic psychiatric care. Health Psychol Behav Med. 2014 Jan 1;2(1):335-348. doi: 10.1080/21642850.2014.894890. Epub 2014 Mar 19.

  PMID: 25750786 BACKGROUND

• Schel SH, Bouman YH, Vorstenbosch EC, Bulten BH. Development of the forensic inpatient quality of life questionnaire: short version (FQL-SV). Qual Life Res. 2017 May;26(5):1153-1161. doi: 10.1007/s11136-016-1461-9. Epub 2016 Nov 22.

  PMID: 27878427 BACKGROUND

• Lingfors H, Persson LG, Lindstrom K, Bengtsson C, Lissner L. Effects of a global health and risk assessment tool for prevention of ischemic heart disease in an individual health dialogue compared with a community health strategy only results from the Live for Life health promotion programme. Prev Med. 2009 Jan;48(1):20-4. doi: 10.1016/j.ypmed.2008.10.009. Epub 2008 Nov 1.

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• Pedersen ALW, Lindekilde CR, Andersen K, Hjorth P, Gildberg FA. Health behaviours of forensic mental health service users, in relation to smoking, alcohol consumption, dietary behaviours and physical activity-A mixed methods systematic review. J Psychiatr Ment Health Nurs. 2021 Jun;28(3):444-461. doi: 10.1111/jpm.12688. Epub 2020 Oct 11.

  PMID: 32916759 BACKGROUND

Related Links

• National Strategy for Mental Health and Suicide Prevention
• Integrating primary care in a specialized forensic psychiatric setting: predictors of program adherence
• Factors associated with quality of life in a cohort of forensic psychiatric in-patients

MeSH Terms

Conditions

Feeding Behavior; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Health Behavior

Central Study Contacts

Mikael Vestlund Wibom, MD, Specialist general medicin

CONTACT

+46721-476597; mikael.vestlund-wibom@kronoberg.se

Märta Wallinius, Associate proffessor

CONTACT

+46709-673004; marta.wallinius@kronoberg.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

SE (1)