Incretin-based Therapies, Nutrition, and Physical Activity

NCT07409831 | Not Yet Recruiting

• 1 other identifier: 2026-4477
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Changes in muscle mass (bioimpedance scale)

  Muscle mass (kg)

  Baseline to 6 months

• Changes in muscular function (handgrip strength)

  Handgrip strength (kg)

  Baseline to 6 months

• Changes in muscular function (short physical performance battery)

  Short physical performance battery (balance, gait speed, lower-limb strength). Minimum: 0; Maximum: 12, with lower scores indicating poorer physical performance.

  Baseline to 6 months

Secondary Outcomes (22)

• Changes in muscle mass (bioimpedance scale)

  Baseline to 12 months

• Changes in muscular function (handgrip strength)

  Baseline to 12 months

• Changes in muscular function (short physical performance battery)

  Baseline to 12 months

• Changes in nutrional intakes (Web-based 24-hour dietary recall)

  Baseline to 6 months and baseline to 12 months

• Changes in diet quality (Web-based 24-hour dietary recall)

  Baseline to 6 months and baseline to 12 months

Study Arms (2)

Medication alone

PLACEBO COMPARATOR

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

Drug: Incretin-Based Treatment

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

EXPERIMENTAL

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)

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

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 pharmacotherapy combined with a 6-month lifestyle intervention

Incretin-Based Treatment DRUG

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.

Medication alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity; Feeding Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Behavior, Animal

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Andréanne Michaud, DtP, PhD

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

  PRINCIPAL INVESTIGATOR

• Fannie Lajeunesse-Trempe, MD PhD FRCPC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Marin-Couture, Kin, PhD

CONTACT

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

Marianne Legault, DtP, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

CA (1)