Incretin-based Therapies, Nutrition, and Physical Activity (HARMONY)

Laval University

Status: Not yet enrolling

Conditions: Obesity & Overweight; Cardiometabolic Conditions

Treatments: Drug: Incretin-Based Treatment; Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07409831

2026-4477

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

Medication alone

Placebo Comparator group

Description:

Participants will be randomly assigned to the incretin-based pharmacotherapy only.

Treatment:

Drug: Incretin-Based Treatment

Incretin-based pharmacotherapy combined with a 6-month lifestyle intervention

Experimental group

Description:

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)

Treatment:

Behavioral: Intervention