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

NCT07605169 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

Individualized physical activity and diet

Precision health

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Chalmers University of Technology

    collaborator OTHER

  • Vastra Gotaland Region

    lead OTHER_GOV

Principal Investigators

  • Mats Börjesson, Professor · University of Gothenburg, Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-11
Primary Completion
2026-05-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605169 on ClinicalTrials.gov