Overview
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
Description
Background Overweight and obese adults, especially those with type 2 diabetes, have increased risk of cardiovascular disease (CVD). Lifestyle interventions with physical activity (PA) and diet improve CVD risk factors, but long-term behavior change is challenging. Individualized approaches are recommended, yet rarely implemented for both PA and diet in clinical practice.
Objectives
The study evaluates whether an individualized precision health intervention:
Produces greater weight loss at 6 months (short-term) and 18 months (long-term)
Improves cardiovascular risk factors, metabolic markers, diet, PA behaviors, fitness, and psychosocial outcomes
Is feasible and cost-effective compared to standard lifestyle advice
Study Design
Randomized controlled trial with two arms:
Intervention group: Individualized precision health program
Control group: Standard lifestyle advice
Total participants: 120 (60 per group), aged 45-65 years, BMI 28-34
Exclusion: known coronary artery disease, inability to participate in lifestyle interventions, or language barriers
Intervention (LI-PAD Precision Health):
Step 1: Individual Adaptation
Adjust recommendations for medical conditions, comorbidities, medications, psychosocial factors, preferences, readiness to change, and barriers/facilitators
Step 2: Individualized Advice
PA prescription based on accelerometry, VO₂max, and muscle strength
Dietary guidance based on food intake diaries and measured resting energy expenditure (REE)
Step 3: Support for Goal Achievement
Education and skill training
Behavioral support: health promoters, group sessions, face-to-face and online coaching, apps for diet and PA, nudging
Control Group:
Standard lifestyle advice: healthy diet, ≥300 min/week moderate-intensity aerobic PA, 2 sessions/week strength training
Outcome Measures:
Primary Outcome:
Change in body weight from baseline to 6 months and 18 months
Secondary Outcomes:
BMI, waist and hip circumference
Blood pressure
Blood markers: cardiometabolic (lipids, HbA1c, cholesterol, HDL, LDL; ASAT, ALAT, ALP, GGT, hs-CRP) and dietary intake biomarkers
Cardiorespiratory fitness and muscle strength
Behavioral measures: PA (accelerometry, SGPALS), diet (MiniMeal-Q, REE)
Psychosocial outcomes: health-related quality of life (EQ5D-3L, RAND-36), motivation, self-efficacy
Cost-effectiveness analysis based on BMI and secondary outcomes
Additional Outcomes (Intervention Group):
Feasibility: attendance, compliance, participant evaluation
Barriers and facilitators to behavioral change
GPS tracking of PA and dietary behavior
- Assessments
Baseline, 6-month, and 18-month follow-ups
Anthropometry, REE, blood pressure, blood markers, fitness tests, accelerometry, questionnaires, and dietary logs
Statistical Analysis:
Multilevel mixed models for repeated measures
Linear and logistic regression for continuous and categorical variables
Structural equation modeling and partial least squares regression to explore relationships between intervention components and outcomes
- Collaborators
Sahlgrenska University Hospital/Östra: health promoters, physiotherapists, biomedical analysts
University of Gothenburg: Food and Nutrition, Sport Science, metabolomics, health economics
National and international collaborators with expertise in PA, diet, and cardiovascular health
- Summary
LI-PAD-Extended is an 18-month follow-up evaluating individualized precision health interventions. The study combines objective PA and dietary assessments with behavioral support and cost-effectiveness evaluation. This long-term follow-up allows assessment of sustained effects of precision lifestyle interventions on weight, cardiovascular risk, fitness, psychosocial outcomes, and economic efficiency.
Eligibility
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
