Recruiting

Incretin with Lifestyle

Sponsor:

Laval University

Code:

NCT07409831

Conditions

Obesity & Overweight

Cardiometabolic Conditions

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Intervention

Incretin-Based Treatment

Study Details

Brief summary:

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.

Conditions

Obesity & Overweight

Cardiometabolic Conditions

Study ID

NCT07409831

Start date

Jul 6, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Medication alone

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

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

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)

Interventions

Intervention

Participants in the intervention will receive standard incretin-based pharmacotherapy combined with an individualized lifestyle intervention. Supervised physical activity sessions, delivered by a registered kinesiologist, will focus primarily on resistance training and will be tailored to each participant's fitness level and medical status to support the preservation of skeletal muscle mass and physical function. In addition, participants will receive personalized nutritional counseling from a registered dietitian to optimize dietary quality, ensure adequate protein intake, and reduce the risk of nutritional deficiencies.

Incretin-Based Treatment

Participants assigned to the medication-only arm will receive standard medical care consisting of incretin-based pharmacotherapy prescribed and monitored by their treating physician, in accordance with usual clinical practice. No structured or supervised physical activity or nutritional intervention will be provided during the study period.

Primary outcome measure

  • Changes in muscle mass (bioimpedance scale) [ Time Frame: Baseline to 6 months ]
  • Changes in muscular function (handgrip strength) [ Time Frame: Baseline to 6 months ]
  • Changes in muscular function (short physical performance battery) [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Elisa Marin-Couture, Kin, PhD

1-418-656-8711elisa.marin-couture.1@ulaval.ca

Marianne Legault, DtP, MSc

1-418-656-8711marianne.legault.2@ulaval.ca

Locations

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Elisa Marin-Couture, PhD

418-656-8711equipe_flt@criucpq.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Incretin-Based Therapies
  • Physical Activity
  • Eating Behaviour
  • Lifestyle Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-07-16.