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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)

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Centre for Lifestyle Intervention
RECRUITING
Gothenburg
Contact Information
Primary
Mats Börjesson, Professor
mats.borjesson@gu.se
+46 0705298360
Backup
Carina U Persson, Associate Professor
carina.persson@vgregion.se
+46 706 14 25 60
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 103
Treatments
Experimental: Individualized Lifestyle Program
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.
No_intervention: Standard of care
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.
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region
Collaborators: Chalmers University of Technology, Göteborg University

This content was sourced from clinicaltrials.gov