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

Recruiting now · Not applicable

Conditions studied: Overweight, Obesity, Prediabetic State

In brief

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

Key facts

Study ID

NCT07605169

Run by

Vastra Gotaland Region

People needed

103

Starts

2025-08-11

Expected to finish

2027-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 45-65 years at baseline of the original LI-PAD study
• Body mass index (BMI) ≥28 and ≤34
• Completed the original LI-PAD study
• Able and willing to attend follow-up assessments and provide necessary data
• Able and willing to provide informed consent

You may not qualify if…

• Known coronary artery disease (clinical symptoms or earlier event)
• Inability to understand the language used in the study
• Inability to complete follow-up assessments at 18 months
• Severe illness or medical condition that, in the investigator's opinion, precludes participation in follow-up assessments

Where it is running

• Centre for Lifestyle Intervention — Gothenburg, Västra Götaland County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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