Incretin-Based Treatment for Obesity
(HARMONY Trial)
What You Need to Know Before You Apply
What is the purpose of 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.
Who Is on the Research Team?
Andréanne Michaud, DtP, PhD
Principal Investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Fannie Lajeunesse-Trempe, MD PhD FRCPC
Principal Investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 with obesity, defined as a BMI ≥30 kg/m² or ≥27 kg/m² with at least one comorbidity. Participants must be receiving routine obesity care and will start incretin-based therapy prescribed by their physician.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive incretin-based pharmacotherapy, with the intervention group also undergoing a six-month structured lifestyle program including exercise and nutrition counseling
Consolidation
Participants in the intervention group continue with a consolidation phase after the initial treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Incretin-Based Treatment
Trial Overview
The study tests if adding a structured lifestyle program (exercise and nutrition) to incretin-based medication improves muscle mass and physical function in obese adults more than medication alone. It also examines the success of combining hospital-community healthcare.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
The intervention group will receive an incretin-based pharmacotherapy combined with a 6-month lifestyle intervention (weekly group exercise sessions, individual consultations with a kinesiologist and a registered dietitian every two months)
Participants will be randomly assigned to the incretin-based pharmacotherapy only.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Laval University
Lead Sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
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