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Clinical Trials in Sweden / NCT07605169
Active, not recruiting Not applicable

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

NCT07605169 · tracked via the Priya Life Science Sweden tracker
Sponsor
Vastra Gotaland Region
Phase
Not applicable
Started
2025-08-11
Last updated
2026-08-28

Condition(s) studied

OverweightObesityPrediabetic State

Investigational drug(s) / intervention(s)

Individualized physical activity and diet

Individualized physical activity and diet: Precision health

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

Eligibility

Sex
ALL
Min age
45 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Centre for Lifestyle Intervention Gothenburg Västra Götaland County

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Other trials for the same condition

Internet Treatment for Patients With Obesity Active, not recruiting
A Study of Eloralintide (LY3841136) in Participants With Overweight or Obesity Recruiting
Effect of Circadian Rhythm and Physical Exercise in Overweight Type 1 Diabetes Patients Recruiting
A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight Active, not recruiting
STEP TEENS Weight Maintenance: A Research Study on How Well Semaglutide Helps Teenagers With Excess Body Weight to Lose Weight and Maintain Weight Loss Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07605169 on ClinicalTrials.gov ↗ ← All trials in Sweden