RecruitingNot Applicable

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

Sweden103 participantsStarted 2025-08-11

Plain-language summary

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

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Body Weight Change

Timeframe: Baseline, 6 months, 18 months

Trial details

NCT IDNCT07605169

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-05-31

Contact for this trial

Mats Börjesson, Professor

+46 0705298360 mats.borjesson@gu.se

View on ClinicalTrials.gov More Overweight trials