Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.
The goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.
The main questions it aims to answer are:
* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease? * Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months? * Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?
Researchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.
During the six month program, participants in the lifestyle group will:
* Meet with a clinical dietitian once a month for dietary counselling * Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan
Around 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.
Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)
Current use of antipsychotic medication (first- or second generation) or lithium
Body Mass Index > or = 27 kg/m²
Inability to provide informed consent*
Acute psychiatric crisis*
Significant cognitive impairment* *These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment
GLP-1 receptor agonists
Parallel
Lifestyle Intervention
BehavioralThe Lifestyle Program consists of monthly one-on-one dietary counselling sessions with a registered clinical dietitian, monthly group-based physical activity sessions led by an instructor, and support to follow a personalized exercise plan. The intervention focuses on cardioprotective dietary changes, weight reduction, and increasing physical activity at moderate-to-high intensity to meet recommended amount. Participants will receive dietary supplementation corresponding to a therapeutic dose of 1000 mg EPA+DHA per day from fish oil. During monthly visits with the dietitian, data will be collected to monitor progress and support adherence. Participants will be encouraged to monitor body weight at home between visits (bathroom scales are loaned as needed), and follow up is carried out biweekly via phone-calls. The intervention is designed to be feasible within routine mental health care and tailored to the needs of adults with severe mental illness.
Change in Estimated Risk of Heart Disease (QRISK3)
Compare the change in estimated cardiovascular disease risk between intervention and control (Treatment as Usual) groups over 6 months, using the validated QRISK3 algorithm.
Association Between Change in Lifestyle Adherence and Change in QRISK3 Score
Explore whether change in adherence to a healthy lifestyle, measured with the DIGIKOST Lifestyle Index, predicts change in estimated cardiovascular disease risk (QRISK3).
Change in Objectively Measured Physical Activity (Accelerometer)
Physical activity will be assessed using a thigh-worn accelerometer worn for 7 consecutive days at baseline and again after 6 months. The device captures activity intensity and duration, including time spent sedentary, standing, and in moderate-to-vigorous physical activity. Between-group differences will be analyzed to evaluate the impact of the lifestyle intervention.
Change in lifestyle adherence score (DIGIKOST Lifestyle Index)
Healthy lifestyle adherence will be measured using the DIGIKOST Lifestyle Index at baseline and 6 months. The index serves as a proxy for behavioral change. Between-group differences (intervention vs. control) in change from baseline will be evaluated after the intervention (6 months)
Change in Diet Quality (DIGIKOST Diet Index and 24-Hour Dietary Recall)
Assess changes in diet quality based on a validated food frequency questionnaire (DIGIKOST Diet Index) and nutritional composition measured with 24-hour dietary recalls (repeated by phone call for validity), relative to Norwegian dietary recommendations. Repeated at baseline and after 6 months
Presence and Change in Metabolic Syndrome (IDF and ATP-III Criteria)
Metabolic syndrome will be assessed at baseline, 3 months, and 6 months using both the International Diabetes Federation (IDF) and the Adult Treatment Panel III (ATP-III) diagnostic criteria. Between-group differences (intervention vs. control) in the prevalence and change in metabolic syndrome status from baseline will be evaluated at 3 and 6 months.
Change in Health-Related Quality of Life (PROMIS-29)
Assess changes in self-reported health-related quality of life using the PROMIS-29 instrument, a validated questionnaire covering physical, mental, and social functioning, in the intervention group compared to treatment as usual. Between-group differences in change from baseline will be evaluated at 3- and 6 months.
Feasibility and Acceptability of the Lifestyle Program (qualitative)
Explore participants' experiences and the perceived feasibility and acceptability of the lifestyle intervention. Data will be collected through field notes, informal participant feedback, and illustrative quotes during dietitian consultations and group sessions. Notes will be recorded continuously by the clinical dietitian and physical activity instructor throughout the 6-month intervention period.
Predictors of adherence and effect heterogeneity
Exploratory analyses will investigate whether baseline characteristics such as diagnosis, sex, BMI, and type of medication predict adherence or modify the effect of the intervention. Analyses will also assess differential responses within subgroups.
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Madeleine Elisabeth Angelsen
Lead sponsor
University of Oslo
Sponsor institution