Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients
NCT ID: NCT07157813
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
50 participants
INTERVENTIONAL
2026-01-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Hospitalized at the forensic psychiatric clinic in Växjö, Sweden.
Exclusion Criteria
* Severe cognitive impairment
* Acute psychiatric states (e.g., suicidality or acute psychosis)
* Aggression hindering safe participation
18 Years
64 Years
ALL
Yes
Sponsors
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Lund University
OTHER
Kronoberg County Council
OTHER_GOV
Responsible Party
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Locations
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Regional Forensic Psychiatric Clinic, Växjö
Vaxjo, Kronoberg County, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Wei TQ, Chu VP, Craig AR, Duffy JE, Obzansky DM, Kilgore D, Masulli IS, Sanders CM, Thompson JC. Automated homogeneous immunoassay for gentamicin on the dimension clinical chemistry system. Clin Chem. 1999 Mar;45(3):388-93.
Cooper A. Hodgkin's disease. Lancet. 1982 Mar 13;1(8272):612-3. No abstract available.
Kuczynska-Sicinska J. [Nephrologic problems in pregnancy]. Pol Arch Med Wewn. 1973 Feb;50(2):221-6. No abstract available. Polish.
Pincelli C, Magni R, Motolese A. Pigmented contact dermatitis from deodorant. Contact Dermatitis. 1993 May;28(5):305-6. doi: 10.1111/j.1600-0536.1993.tb03447.x. No abstract available.
Davis RH, Hynes LV, Eversole-Cire P. Nonsense mutations of the ornithine decarboxylase structural gene of Neurospora crassa. Mol Cell Biol. 1987 Mar;7(3):1122-8. doi: 10.1128/mcb.7.3.1122-1128.1987.
Gupta MM, Srinivasa H, Bhat P. Seroepidemiology of malaria in Karnataka State: longitudinal study of a population from an area with high incidence at Kolar, South India. J Infect Dis. 1983 Sep;148(3):609. doi: 10.1093/infdis/148.3.609.
Hamilton RL, Brown WJ. Medium to aid identification of Serratia marcescens. Am J Med Technol. 1972 Mar;38(3):73-6. No abstract available.
Hsu SH, Pollard MK, Chan MM, Bias WB. Genetic heterogeneity of DR4 in the Old Order Amish and two new HLA-D specificities. Hum Immunol. 1981 Mar;2(2):165-72. doi: 10.1016/0198-8859(81)90063-x.
Winkelmann U. [Influencing factors in the planning of job needs]. Krankenpfl J. 1980 Jul 15;18(7):28-9. No abstract available. German.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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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
Other Identifiers
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2025-02066-01
Identifier Type: OTHER
Identifier Source: secondary_id
FOR-HEALTH
Identifier Type: -
Identifier Source: org_study_id
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