Exercise, diet and educational interventions for metabolic syndrome in persons with schizophrenia: A systematic review.
Jothimani Gurusamy, Sailaxmi Gandhi, Dinakaran Damodharan...
https://pubmed.ncbi.nlm.nih.gov/29990631/Actively Recruiting
Led by Madeleine Elisabeth Angelsen · Updated on 2025-10-02
70
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether a lifestyle program combining dietary counselling and regular physical exercise can improve physical and mental health in Norwegian adults with severe mental illnesses SMI such as schizophrenia spectrum or bipolar disorder. These individuals face a higher risk of early death, mainly due to heart disease, caused partly by unhealthy lifestyle habits and metabolic side effects of medications. The trial aims to test if this program can reduce estimated heart disease risk and improve lifestyle habits, body weight, and metabolic markers over six months. Participants will be randomly assigned to one of two groups one receiving a 6-month lifestyle program plus usual mental health care, and the other receiving usual care only. The lifestyle program includes monthly individual sessions with a clinical dietitian focused on heart-healthy dietary changes and weight reduction, monthly group physical activity sessions led by an instructor, and support to follow a personalized moderate-to-high intensity training plan. Participants in the lifestyle group also receive omega-3 supplementation and are encouraged to monitor body weight at home, with biweekly phone support. During the study, researchers will assess changes in estimated 10-year cardiovascular disease risk, lifestyle adherence, physical activity measured by accelerometer, diet quality, body composition, waist circumference, weight, blood pressure, and relevant biomarkers. Measurements occur at baseline, 3 months, and 6 months, with statistical analysis to evaluate differences between groups. The study also evaluates feasibility and acceptability of the program for people with SMI. Around 70 adults aged 25 to 70 with schizophrenia spectrum or bipolar disorder will participate, with data collected over the six-month intervention period.
CONDITIONS
Norwegian Mental Illness Heart Health Study
M
Madeleine E Angelsen, M.Sc. Clinical Nutrition
P
Professor Kjetil Retterstøl, Professor, MD
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Madeleine Elisabeth Angelsen
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a 6-month lifestyle program including monthly one-on-one dietary counselling sessions with a clinical dietitian, monthly group-based physical activity sessions led by an instructor, support to follow a personalized exercise plan, and omega-3 supplementation. Participants are encouraged to monitor body weight at home and receive biweekly phone calls for support and adherence monitoring.
Monthly individual sessions and group physical activity sessions, plus biweekly phone calls
Duration - Concurrent with intervention period at 3 and 6 months
Participants are assessed at 3 months and 6 months during the intervention for changes in cardiovascular risk, lifestyle adherence, physical activity, diet quality, metabolic health, and body composition.
Assessments occur at baseline, 3 months, and 6 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Jothimani Gurusamy, Sailaxmi Gandhi, Dinakaran Damodharan...
https://pubmed.ncbi.nlm.nih.gov/29990631/Madeleine Elisabeth Angelsen, Hemen Najar, Mette Svendsen...
https://pubmed.ncbi.nlm.nih.gov/41769638/Tetyana Rocks, Scott B Teasdale, Caitlin Fehily...
https://pubmed.ncbi.nlm.nih.gov/36183316/Madeleine Elisabeth Angelsen
Lead Sponsor