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Incretin-based Therapies, Nutrition, and Physical Activity

Study acronym: HARMONY
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Start date changed from estimate of Mar 2026 to Jul 6, 2026
    • Study sites: 1 to 2
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07409831
Lead Sponsor Laval University
Collaborators: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions
(from sponsor)
Obesity & Overweight, Cardiometabolic Conditions
Related terms Feeding Behavior, Motor Activity, Obesity, Overweight
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov