Incretin-based Therapies, Nutrition, and Physical Activity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLaval University
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 70 years
BMI >30 kg/m2, or
BMI >27 kg/m2 with presence of comorbidities (e.g., type II diabetes, hypertension, hypercholesterolemia)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention
BehavioralParticipants 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
DrugParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Medication alonePlacebo comparator 1 intervention
Group B: Incretin-based pharmacotherapy combined with a 6-month lifestyle interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg)
Time frame
Baseline to 6 months2
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Time frame
Baseline to 6 months3
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.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg) variation
Time frame
Baseline to 12 months2
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Time frame
Baseline to 12 months3
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.
Time frame
Baseline to 12 months4
Changes in nutrional intakes (Web-based 24-hour dietary recall)
Macro- and micro-nutrients intakes
Time frame
Baseline to 6 months and baseline to 12 monthsSponsors and contacts
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Laval University
Lead sponsor
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Source ClinicalTrials.gov