Incretin-based Therapies, Nutrition, and Physical Activity

Official title

Holistic Approach to Cardiometabolic Health and Obesity: Incretin-based Therapies, Nutrition, and Active Lifestyle

Overview

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.

Interventions

• Behavioral 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 r
• Drug 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 measures

• 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]

Secondary outcome measures (12)

• Changes in muscle mass (bioimpedance scale) [Time frame: Baseline to 12 months]
• Changes in muscular function (handgrip strength) [Time frame: Baseline to 12 months]
• Changes in muscular function (short physical performance battery) [Time frame: Baseline to 12 months]
• Changes in nutrional intakes (Web-based 24-hour dietary recall) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in diet quality (Web-based 24-hour dietary recall) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in body composition (bioimpedance scale) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in body mass index (bioimpedance scale) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in visceral fat levels (bioimpedence scale) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in glycemic profiles (blood sample) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in lipid profiles (blood sample) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in hemodynamic measurements (sphygmomanometer) [Time frame: Baseline to 6 months and baseline to 12 months]
• Changes in hepatic biomarkers (blood sample) [Time frame: Baseline to 6 months and baseline to12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 2 centers

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

Identifiers

NCT: NCT07409831 · 2026-4477

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗