NCT07605169 Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)
| NCT ID | NCT07605169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 103 participants |
| Start Date | 2025-08-11 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 103 participants in total. It began in 2025-08-11 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Mats Börjesson, Professor
PRINCIPAL INVESTIGATOR
University of Gothenburg, Sahlgrenska University Hospital
Frequently Asked Questions
Who can join the NCT07605169 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 65 Years, studying Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07605169 currently recruiting?
Yes, NCT07605169 is actively recruiting participants. Contact the research team at mats.borjesson@gu.se for enrollment information.
Where is the NCT07605169 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT07605169 clinical trial?
NCT07605169 is sponsored by Vastra Gotaland Region. The principal investigator is Mats Börjesson, Professor at University of Gothenburg, Sahlgrenska University Hospital. The trial plans to enroll 103 participants.