An interventional study of Structured Health Dialogue in Forensic Psychiatric Patients, Cardio Vascular Disease and Health Promotion, sponsored by Kronoberg County Council. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Kronoberg County Council · Not applicable, Interventional, and Prevention
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.
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.
985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.
This study's planned enrollment of 50 is below the median of 77 across 700 interventional studies indexed under Feeding Behavior.
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Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: 24-month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Biometric measures, Body Length (Height)
Measured (cm) in both groups at baseline using a stadiometer according to standard clinical equipment and protocols.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 12 months
Family History of Cardiovascular Disease and Diabetes
Collected in both groups at baseline through patient interview or from medical records.
Time frame: 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.
Time frame: Baseline (single assessment)
Started Mar 2026 (actual). Primary completion is estimated for Dec 2027, 21 months after the start.
Of 503 non-industry interventional studies with no phase under Feeding Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 21 months is above that.
Counting every sponsor, half of 515 studies reached it within 14 months; a quarter within 5 and three quarters within 31.
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Kronoberg County Council