NCT07409831

Incretin-based Therapies, Nutrition, and Physical Activity

Holistic Approach to Cardiometabolic Health and Obesity: Incretin-based Therapies, Nutrition, and Active Lifestyle

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate whether combining a six-month structured lifestyle intervention (physical activity and nutrition) with incretin-based weight-loss medication improves preservation of muscle mass and physical function in adults living with obesity, compared with medication alone, and to assess the feasibility of a collaborative hospital-community care model. This one-year pilot study will recruit 120 adults aged 18-70 years with obesity (BMI ≥30 kg/m² or ≥27 kg/m² with at least one comorbidity) receiving routine obesity care at the Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval. All participants will initiate physician-prescribed incretin-based therapy as part of standard care. The intervention group will receive medication plus a six-month structured lifestyle program delivered in collaboration with an exercise facility, including supervised strength-focused exercise and bi-monthly nutrition counseling, followed by a six-month consolidation phase. The control group will receive medication alone. Outcomes will be assessed at baseline and at 3, 6, and 12 months. Participants will be randomly assigned in a 1:1 ratio to either the medication-only group or the combined medication and lifestyle intervention group. Participants randomized in the medication only group will receive a personalized consult with both a registered dietician and kinesiologist at the end of the study.

Conditions

• Obesity & Overweight
• Cardiometabolic Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	Participants in the intervention will receive standard incretin-based pharmacotherapy combined with an individualized lifestyle intervention. Supervised physical activity sessions, delivered by a registered kinesiologist, will focus primarily on resistance training and will be tailored to each participant's fitness level and medical status to support the preservation of skeletal muscle mass and physical function. In addition, participants will receive personalized nutritional counseling from a registered dietitian to optimize dietary quality, ensure adequate protein intake, and reduce the risk of nutritional deficiencies.
DRUG	Incretin-Based Treatment	Participants assigned to the medication-only arm will receive standard medical care consisting of incretin-based pharmacotherapy prescribed and monitored by their treating physician, in accordance with usual clinical practice. No structured or supervised physical activity or nutritional intervention will be provided during the study period.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Locations

1 site across 1 country: Canada