Forensic Psychiatric PatientsFOR-HEALTHNCT07157813
Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients
A study testing Structured Health Dialogue in people with Forensic Psychiatric Patients and Cardio Vascular Disease, run by Kronoberg County Council at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Forensic Psychiatric Patients, Cardio Vascular Disease, Health Promotion
- What is being tested?
- Structured Health Dialogue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-64 years
- Hospitalized at the forensic psychiatric clinic in Växjö, Sweden.
Who cannot join
- Severe language barriers.
- Severe cognitive impairment
- Acute psychiatric states (e.g., suicidality or acute psychosis)
- Aggression hindering safe participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Regional Forensic Psychiatric Clinic, Växjö
Vaxjo, Kronoberg County
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Forensic Psychiatric Patients, Cardio Vascular Disease, Health Promotion, Forensic Mental Health, Forensic Psychiatry, Physical Fittness
- Being tested
- Structured Health Dialogue
- Keywords
- Health dialog
- Medical subject headings
- Feeding Behavior, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Health DialogueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24-month
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Biometric measures, Body Length (Height)
Measured (cm) in both groups at baseline using a stadiometer according to standard clinical equipment and protocols.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Forensic Psychiatric PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Collaborators
- Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157813
- Sponsor's protocol ID
- FOR-HEALTH
- Other IDs
- 2025-02066-01, 2025
- Acronym
- FOR-HEALTH
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37009123Voulgaris 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.
PubMed 30210374Blomstedt 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.
PubMed 26685034Laporte 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.
PubMed 34408680Bushe 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.
PubMed 20923917Lingfors 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.
PubMed 30696668Brown 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.
PubMed 20118455Howner 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.
PubMed 30319459Andine 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.
PubMed 31849721Rabin 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.
PubMed 11491192Johansson 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.
PubMed 20001478Uhrskov 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.
PubMed 32248726Dronavalli 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.
PubMed 40356373Vorstenbosch 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.
PubMed 25750786Schel 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.
PubMed 27878427
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients
- ClinicalTrials.gov ID
- NCT07157813
- Acronym / sponsor ID
- FOR-HEALTH / FOR-HEALTH
- Conditions
- Forensic Psychiatric Patients, Cardio Vascular Disease, Health Promotion, Forensic Mental Health, Forensic Psychiatry, Physical Fittness
- Keywords
- Health dialog
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kronoberg County CouncilOther government
- Collaborators
- Lund University
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Health Dialogue | Experimental | Behavioral: Structured Health DialogueParticipants 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). |
| 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 18-64 years
- Hospitalized at the forensic psychiatric clinic in Växjö, Sweden.
Key exclusion criteria (4 listed)
- Severe language barriers.
- Severe cognitive impairment
- Acute psychiatric states (e.g., suicidality or acute psychosis)
- Aggression hindering safe participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Health DialogueIn 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. | Behavioural | Structured Health Dialogue |
Primary outcome
Feasibility of the study design and Targeted health dialogue
Time frame: 24-month
Recruitment rate in both groups calculated continuously throughout the recruitment period, reported as the number of participants enrolled per month.
Feasibility of the study design and Targeted health dialogue
Time frame: 24-month
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.
13 secondary outcomes
Biometric measures, Body Mass Index (BMI)
Time frame: 12 months
Biometric measures, Waist-to-Hip Ratio
Time frame: 12 months
Biometric measures, Blood Pressure
Time frame: 12 months
Biometric measures, Fasting Plasma Glucose
Time frame: 12 months
Biometric measures, Blood Lipid Status
Time frame: 12 months
Biometric measurments, Body Weight
Time frame: 12 months
Biometric measures, Body Length (Height)
Time frame: 12 months
Lifestyle Habits - Physical Activity
Time frame: 12 months
Lifestyle Habits - Diet
Time frame: 12 months
Lifestyle Habits - Tobacco Use
Time frame: 12 months
Lifestyle Habits - Alcohol Consumption
Time frame: 12 months
Mental Fatigue
Time frame: 12 months
Self-Reported Health Status
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 37009123Sivak 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.
- Background: PubMed 30210374Voulgaris 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.
- Background: PubMed 26685034Blomstedt 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.
- Background: PubMed 34408680Laporte 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.
- Background: PubMed 20923917Bushe 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.
- Background: PubMed 30696668Lingfors 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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- National Strategy for Mental Health and Suicide PreventionLink provided by the sponsor.
- Integrating primary care in a specialized forensic psychiatric setting: predictors of program adherenceLink provided by the sponsor.
- Factors associated with quality of life in a cohort of forensic psychiatric in-patientsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Health Dialogue in people with Forensic Psychiatric Patients and Cardio Vascular Disease, run by Kronoberg County Council at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study design and Targeted health dialogue (time frame: 24-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157813, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.