RecruitingNot ApplicableNCT07605169

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

Long-term Follow-up of Individualized Lifestyle Intervention Focused on Physical Activity and Diet: Effects on Weight Loss, Dietary Habits, Cardiovascular Health, Motivation, Health-related Quality of Life, and Health Economics (LI-PAD-Extended)


Sponsor

Vastra Gotaland Region

Enrollment

103 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 45 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALIndividualized physical activity and diet

Precision health


Locations(1)

Centre for Lifestyle Intervention

Gothenburg, Västra Götaland County, Sweden

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07605169


Related Trials