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

NCT07605169 | Recruiting

• 2 other identifiers: LI-PAD EXTENDED285373
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight; Obesity; Prediabetic State

Keywords

Lifestyle intervention; Physical activity; Diet; Precision health; Overweight; Obesity; Weight loss; Cardiometabolic risk; Health-related quality of life; Behavioral support; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Body Weight Change

  Change from baseline in body weight measured using calibrated scales and standardized protocols.

  Baseline, 6 months, 18 months

Secondary Outcomes (35)

• Change in Body Mass Index (BMI)

  Baseline, 6 months, 18 months.

• Change in Systolic Blood Pressure

  Baseline, 6 months, 18 months

• Change in Waist Circumference

  Baseline, 6 months, 18 months

• Change in Hip Circumference

  Baseline, 6 months, 18 months

• Change in Total Cholesterol

  Baseline, 6 months, 18 months

Study Arms (2)

Individualized Lifestyle Program

EXPERIMENTAL

The intervention group will receive (offered) an optimal prescription of physical activity and diet based on medical (comorbidities, risk profile, medications, symptoms) and psycho-social (preferences for physical activities and diet, barriers-facilitators, social support, readiness to change, accelerometry and predicted VO2-max data (Ekblom Bak ergometer test), resting energy expenditure and knowledge and skills (lifestyle education school for achieving knowledge and skills in handling change in diet and physical activity in daily life) and support (health promotors, behavioral change app, food diary app, face-to-face, phone/online coaching, physical activity (aerobic training, strength training) in group and nudging.

Behavioral: Individualized physical activity and diet

Standard of care

NO INTERVENTION

The control group will receive (be offered) usual care defined as written lifestyle advices based on the general recommendations for diet (Nordic Nutrition Recommendations, 2012. Integrating nutrition and physical activity. Copenhagen: Nordic Council of Ministers, 2014) and PA (World Health Organization. World Health Organization guidelines on physical activity and sedentary behavior, 2020), including a healthy and varied diet, aiming at 300 mins/week of medium intensity aerobic PA and strength training two times per week.

Interventions

Individualized physical activity and diet BEHAVIORAL

Precision health

Individualized Lifestyle Program

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator
• Chalmers University of Technology: collaborator

Study Sites (1)

Centre for Lifestyle Intervention

Gothenburg, Västra Götaland County, 416 85, Sweden

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Prediabetic State; Motor Activity; Weight Loss

Interventions

Diet

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Mats Börjesson, Professor

  University of Gothenburg, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mats Börjesson, Professor

CONTACT

+46 0705298360; mats.borjesson@gu.se

Carina U Persson, Associate Professor

CONTACT

+46 706 14 25 60; carina.persson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, intervention staff, and study personnel are aware of group assignments due to the nature of the lifestyle intervention. Full blinding is not possible because participants actively engage in individualized physical activity, dietary counseling, and behavioral support. Outcome assessments are performed using objective measurements whenever possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to either the individualized lifestyle intervention group or the control group receiving standard lifestyle advice. Both groups are followed simultaneously over 18 months to compare outcomes on weight, cardiometabolic risk factors, physical activity, diet, fitness, quality of life, and cost-effectiveness.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: May 22, 2026
• Study Start: August 11, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)