Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients (FOR-HEALTH)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation; Health Promotion; Cardio Vascular Disease; Diet Habits; Forensic Psychiatry; Physical Fittness; Forensic Psychiatric Patients; Forensic Mental Health
• Intervention / Treatment: Behavioral: Structured Health Dialogue

Detailed Description

Individuals receiving compulsory forensic psychiatric care typically present with severe mental disorders such as schizophrenia, schizoaffective disorder, or personality disorders, and are legally detained following offenses committed under the influence of psychiatric illness. This patient population has a markedly reduced life expectancy-by up to 15-20 years-primarily due to preventable somatic conditions such as cardiovascular disease, type 2 diabetes, and other metabolic disorders. Contributing factors include sedentary lifestyle, unhealthy dietary patterns, tobacco and alcohol use, limited health literacy, and the metabolic side effects of long-term antipsychotic treatment. The restrictive environment of secure psychiatric care may further limit opportunities for physical activity and healthy eating. Epidemiological studies consistently show that obesity, metabolic syndrome, and cardiometabolic risk factors are highly prevalent among forensic psychiatric inpatients, with rates often exceeding those observed in both the general population and other psychiatric settings. Despite this, structured preventive health interventions are rarely implemented in forensic psychiatry, and evidence on how such programs can be adapted to this context remains limited.

The Structured Health Dialogue (SHD) is a validated Swedish primary care method for cardiovascular disease prevention. It integrates evidence-based behavioural strategies such as motivational interviewing with an individualized risk assessment. Central to the method is a visual tool, the so-called "health curve," which is generated from systematically collected data including biometric measurements, laboratory tests, and a structured lifestyle questionnaire. This visual risk profile provides a concrete and accessible summary of the individual's cardiometabolic risk factors, which is then used as the foundation for the health dialogue. By combining objective data with motivational interviewing, SHD facilitates patient engagement, enhances understanding of risk, and supports goal-setting for behavioural change. Evidence from primary care indicates that SHD improves lifestyle habits, metabolic health indicators, and patient participation in preventive care. However, its feasibility and potential effectiveness in compulsory forensic psychiatric care have not yet been evaluated in a randomized controlled setting.

This study is designed as a single-centre, parallel-group randomized controlled feasibility trial conducted at the Regional Forensic Psychiatric Clinic in Växjö, Sweden. The trial follows methodological guidance for feasibility and pilot studies and will be reported according to the CONSORT 2010 extension for pilot and feasibility trials. Eligible participants will be randomized in a 1:1 ratio to either the intervention group (SHD plus usual care) or the control group (usual care only). Randomization will be stratified by ward type and implemented using a computer-generated sequence with block randomization within security classes I-III. Block randomization is applied to ensure balance between groups, as patients in class I wards are often in an earlier phase of treatment or present with more severe psychiatric symptoms compared to patients in classes II and III. From a methodological perspective, stratification and block randomization by security class reduces the risk of systematic imbalance in baseline characteristics, thereby controlling for potential confounding related to ward type and severity of illness.

The intervention consists of two nurse-led SHD sessions delivered over a 12-month period. Each session lasts approximately 60-90 minutes and includes systematic health screening (anthropometric and biometric measures, fasting blood tests), a structured lifestyle questionnaire, and individualized risk feedback using the health curve. The sessions employ motivational interviewing techniques to support patient autonomy, set realistic lifestyle goals, and identify strategies for behavioural change. Tailored recommendations and referrals to relevant health services are provided when needed.

Assessments are scheduled at baseline, 6 months, and 12 months, including biometric measurements and validated self-report questionnaires on lifestyle behaviours, quality of life, and functioning. Feasibility outcomes include recruitment rates, retention, adherence to intervention and follow-up, and completeness of data collection. Secondary outcomes will provide preliminary estimates of intervention effects on metabolic risk factors, lifestyle habits, and self-reported quality of life, which will inform the design of a future adequately powered randomized controlled trial.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Kronoberg County
    • Vaxjo, Kronoberg County, Sweden
      • Regional Forensic Psychiatric Clinic, Växjö

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Structured Health Dialogue; 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; 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.
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biometric measures, Fasting Plasma Glucose	Measured in both groups at baseline, 6 months, and 12 months through blood sampling under standardized conditions. Both short-term fP-Glucose (mmol/L) and long-term glucose HbA1c (mmol/mol) control will be assessed.	12 months
Biometric measurments, Body Weight	Measured (kg) in both groups at baseline, 6 months, and 12 months using a calibrated clinical scale according to standard procedures.	12 months
Biometric measures, Body Length (Height)	Measured (cm) in both groups at baseline using a stadiometer according to standard clinical equipment and protocols.	12 months
Biometric measures, Body Mass Index (BMI)	Calculated in both groups at baseline, 6 months, and 12 months from measured body weight and height using standard clinical equipment and protocols. Category BMI Range (kg/m²) Underweight < 18.5 Normal weight 18.5 - 24.9 Overweight 25.0 - 29.9 Obesity Class I 30.0 - 34.9 Obesity Class II 35.0 - 39.9 Obesity Class III (severe) ≥ 40.0 In the "Hälsokurvan" system, the cut-off values for BMI differ from the standard WHO categories. For men, a BMI below 27.0 is classified as low risk (green), 27.0-36.9 as moderate risk (yellow), and 37.0 or higher as high risk (orange). For women, a BMI below 29.0 is considered low risk, 29.0-38.9 moderate risk, and 39.0 or higher high risk.	12 months
Biometric measures, Waist-to-Hip Ratio	Measured in both groups at baseline, 6 months, and 12 months using a measuring tape according to standard procedures. n the "Hälsokurvan" system, waist-to-hip ratio (WHR) is divided into four risk categories. For men, values below 0.90 are classified as low risk, 0.90-0.94 as moderate risk, 0.95-0.99 as high risk, and 1.00 or higher as very high risk. For women, values below 0.78 are classified as low risk, 0.78-0.82 as moderate risk, 0.83-0.87 as high risk, and 0.88 or higher as very high risk.	12 months
Biometric measures, Blood Pressure	Recorded in both groups at baseline, 6 months, and 12 months using standard clinical procedures. In the "Hälsokurvan" system, normal blood pressure is defined as systolic ≤130 mmHg and/or diastolic ≤85 mmHg in otherwise healthy individuals. Values above this level are categorized into increasing risk levels: systolic 140-169 mmHg or diastolic 90-104 mmHg corresponds to a moderate (yellow) category, 170-199/105-114 mmHg to a high (orange) category, and systolic ≥200 mmHg or diastolic ≥115 mmHg to a very high (red) category.	12 months
Biometric measures, Blood Lipid Status	Assessed in both groups at baseline, 6 months, and 12 months via blood sampling under standardized conditions, including total cholesterol (mmol/L), LDL(mmol/l), HDL(mmol/L), and triglycerides (mmol/L). In the Hälsokurvan system, blood lipids are primarily assessed through total cholesterol. Total cholesterol values below 7.5 mmol/L and LDL values below 4.9 mmol/L are managed by calculating the SCORE risk to classify overall cardiovascular risk. The system classifies risk into four levels (green, yellow, orange, red) based on these thresholds together with additional risk factors.	12 months
Lifestyle Habits - Physical Activity	Categorised according to the Hälsokurvan health survey standard. Measured in both groups at baseline and 12 months. Green (low risk): ≥2000 kcal/week or ≥300 min/week (≥10,000 steps/day) Yellow (moderate risk): 1000-1999 kcal/week or 150-299 min/week Orange (high risk): 500-999 kcal/week or 60-149 min/week Red (very high risk): <500 kcal/week or <60 min/week Outcome: Improvement = one-step reduction in risk from baseline.	12 months
Lifestyle Habits - Diet	Categorised according to the Hälsokurvan health survey standard.Measured in both groups at baseline and 12 months. Green (low risk): Healthy diet in line with national recommendations (high in fruit/vegetables, whole grains, legumes, fish; low in salt, sugar, red/processed meat) Yellow (moderate risk): Partly healthy diet with clear areas for improvement Orange (high risk): Several unhealthy components (high sugar, saturated fat, processed meat) Red (very high risk): Predominantly unhealthy diet (energy-dense, nutrient-poor, minimal fruit/vegetables) Outcome: Improvement = one-step reduction in risk from baseline	12 months
Lifestyle Habits - Tobacco Use	Categorised according to the Hälsokurvan health survey standard.Measured in both groups at baseline and 12 months. Green (low risk): No tobacco or nicotine use Yellow (moderate risk): Former or occasional user (non-daily) Orange (high risk): Daily use in small amounts (e.g., 1-9 cigarettes/day) Red (very high risk): Daily use in larger amounts (≥10 cigarettes/day or equivalent) Outcome: Improvement = one-step reduction in risk from baseline	12 months
Lifestyle Habits - Alcohol Consumption	Categorised according to the Hälsokurvan health survey standard.Measured in both groups at baseline and 12 months. Green (low risk): <4 standard drinks/week Yellow (moderate risk): 4-9 drinks/week Orange (high risk): 10-18 drinks/week or binge ≥4 drinks/monthly Red (very high risk): >18 drinks/week or binge ≥4 drinks/weekly Outcome: Improvement = one-step reduction in risk from baseline	12 months
Mental Fatigue	Change in Mental Fatigue Scale (MFS) total score from baseline to 12 months. The MFS ranges from 0 (no mental fatigue) to 42 (maximum mental fatigue). Higher scores indicate worse outcome (greater fatigue), while lower scores indicate better outcome (less fatigue).	12 months
Self-Reported Health Status	Change in health status from baseline to 12 months measured with the EQ-5D questionnaire. EQ-5D Index score: 0 (equivalent to death) to 1 (full health), higher scores = better outcome. EQ-5D VAS: 0 (worst imaginable health) to 100 (best imaginable health), higher scores = better outcome.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family History of Cardiovascular Disease and Diabetes	Collected in both groups at baseline through patient interview or from medical records.	Baseline (single assessment)
Sociodemographic and Clinical Information	Collected in both groups at baseline from patients' medical records, including age, educational level, and current psychiatric diagnoses.	Baseline (single assessment)

Collaborators and Investigators

• Sponsor: Kronoberg County Council
• Collaborators: Lund University

Publications and helpful links

General Publications

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
• Casey DE, Haupt DW, Newcomer JW, Henderson DC, Sernyak MJ, Davidson M, Lindenmayer JP, Manoukian SV, Banerji MA, Lebovitz HE, Hennekens CH. Antipsychotic-induced weight gain and metabolic abnormalities: implications for increased mortality in patients with schizophrenia. J Clin Psychiatry. 2004;65 Suppl 7:4-18; quiz 19-20. No abstract available.
• Osby U, Correia N, Brandt L, Ekbom A, Sparen P. Mortality and causes of death in schizophrenia in Stockholm county, Sweden. Schizophr Res. 2000 Sep 29;45(1-2):21-8. doi: 10.1016/s0920-9964(99)00191-7.
• 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.
• 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.
• Sivak L, Forsman J, Masterman T. Duration of forensic psychiatric care and subsequent criminal recidivism in individuals sentenced in Sweden between 2009 and 2019. Front Psychiatry. 2023 Mar 14;14:1129993. doi: 10.3389/fpsyt.2023.1129993. eCollection 2023.
• Voulgaris A, Kose N, Konrad N, Opitz-Welke A. Prison Suicide in Comparison to Suicide Events in Forensic Psychiatric Hospitals in Germany. Front Psychiatry. 2018 Aug 28;9:398. doi: 10.3389/fpsyt.2018.00398. eCollection 2018.
• Blomstedt Y, Norberg M, Stenlund H, Nystrom L, Lonnberg G, Boman K, Wall S, Weinehall L. Impact of a combined community and primary care prevention strategy on all-cause and cardiovascular mortality: a cohort analysis based on 1 million person-years of follow-up in Vasterbotten County, Sweden, during 1990-2006. BMJ Open. 2015 Dec 18;5(12):e009651. doi: 10.1136/bmjopen-2015-009651.
• 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.
• Bushe CJ, Taylor M, Haukka J. Mortality in schizophrenia: a measurable clinical endpoint. J Psychopharmacol. 2010 Nov;24(4 Suppl):17-25. doi: 10.1177/1359786810382468.
• Brown S, Kim M, Mitchell C, Inskip H. Twenty-five year mortality of a community cohort with schizophrenia. Br J Psychiatry. 2010 Feb;196(2):116-21. doi: 10.1192/bjp.bp.109.067512.
• Howner K, Andine P, Bertilsson G, Hultcrantz M, Lindstrom E, Mowafi F, Snellman A, Hofvander B. Mapping Systematic Reviews on Forensic Psychiatric Care: A Systematic Review Identifying Knowledge Gaps. Front Psychiatry. 2018 Sep 25;9:452. doi: 10.3389/fpsyt.2018.00452. eCollection 2018.
• Andine P, Bergman H. Focus on Brain Health to Improve Care, Treatment, and Rehabilitation in Forensic Psychiatry. Front Psychiatry. 2019 Nov 26;10:840. doi: 10.3389/fpsyt.2019.00840. eCollection 2019. No abstract available.
• Johansson B, Starmark A, Berglund P, Rodholm M, Ronnback L. A self-assessment questionnaire for mental fatigue and related symptoms after neurological disorders and injuries. Brain Inj. 2010 Jan;24(1):2-12. doi: 10.3109/02699050903452961.
• 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.
• 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.
• 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.
• Eliasson M, Eriksson M, Lundqvist R, Wennberg P, Soderberg S. Comparison of trends in cardiovascular risk factors between two regions with and without a community and primary care prevention programme. Eur J Prev Cardiol. 2018 Nov;25(16):1765-1772. doi: 10.1177/2047487318778349. Epub 2018 May 30.
• Weinehall L, Hellsten G, Boman K, Hallmans G, Asplund K, Wall S. Can a sustainable community intervention reduce the health gap?--10-year evaluation of a Swedish community intervention program for the prevention of cardiovascular disease. Scand J Public Health Suppl. 2001;56:59-68.
• Laursen TM, Nordentoft M, Mortensen PB. Excess early mortality in schizophrenia. Annu Rev Clin Psychol. 2014;10:425-48. doi: 10.1146/annurev-clinpsy-032813-153657. Epub 2013 Dec 2.
• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: August 28, 2025
• First Posted (Actual): September 5, 2025

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Health dialog
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Behavior, Animal; Smoking Cessation; Feeding Behavior
• Other Study ID Numbers: FOR-HEALTH; 2025-02066-01 (Other Identifier: The Swedish Ethical Review Authority)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No