Incretin-based Therapies, Nutrition, and Physical Activity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLaval University

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 to 70 years

BMI >30 kg/m2, or

BMI >27 kg/m2 with presence of comorbidities (e.g., type II diabetes, hypertension, hypercholesterolemia)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Intervention
  • Incretin-Based Treatment

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Laval University

Lead sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Collaborator