Incretin-based Therapies, Nutrition, and Physical Activity
Recruiting · NCT07409831 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Adults aged 18 to 70 years
- Prescribed, but not yet initiated, incretin-based pharmacotherapy \[e.g., GLP-1 receptor agonist or dual GIP/GLP1 agonist\] living with obesity, defined as:
- BMI \>30 kg/m2, or
- BMI \>27 kg/m2 with presence of comorbidities (e.g., type II diabetes, hypertension, hypercholesterolemia)
Exclusion criteria
- Medical contraindications to physical activity practice (e.g., unstable cardiovascular disease, severe orthopedic limitation)
- Prior or ongoing incretin-based therapy or history of bariatric surgery
- Pregnancy, current breastfeeding or planned pregnancy during the study period
- Implemented medical devices (e.g. pacemaker, defibrillator)
- Chronic conditions affecting protein metabolism or nutrition (e.g., advanced kidney disease, active cancer)
Where it is running
2 locations listed.
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval - Québec, Quebec, Canada
- Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval - Québec, Quebec, Canada