Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)

The goal of this clinical trial is to learn if an individualized lifestyle intervention works to improve weight, diet, physical activity, cardiovascular health, health-related quality of life, and cost-effectiveness in overweight and obese adults aged 45-65 years. The main questions it aims to answer are: Does the intervention lead to sustained weight loss after 18 months? Does the intervention improve cardiovascular risk factors, metabolic markers, and health-related quality of life compared to general written advice? Is the intervention cost-effective? Researchers will compare the individualized lifestyle intervention to a control group that receives general written advice on physical activity and diet to see if the intervention provides greater long-term health and economic benefits. Participants will: Attend counseling sessions with a health promoter Take part in supervised aerobic and resistance training with a physiotherapist Use swimming facilities and participate in the Lifestyle School Access a digital health coach and the online Lifestyle Tool Complete measurements of body weight, diet, physical activity, and cardiovascular health markers (waist-to-hip ratio, blood pressure, blood lipids, fasting glucose, HbA1c, CRP, and liver enzymes) Complete assessments of resting energy expenditure, aerobic fitness, muscle strength, motivation, and health-related quality of life Provide blood samples at baseline, 6 months, and 18 months for dietary biomarker analysis Contribute data for health economic evaluation to assess cost-effectiveness

NCT Number	NCT07605169
Lead Sponsor	Vastra Gotaland Region Collaborators: Göteborg University, Chalmers University of Technology
Conditions	Overweight, Obesity, Prediabetic State
Enrollment	103 participants
Start Date	2025-08-11
Primary Completion	2026-05-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-22