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

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.