Cardiometabolic Conditions, Obesity & Overweight
Conditions
Keywords
Obesity, Incretin-Based Therapies, Physical Activity, Eating Behaviour, Lifestyle Intervention
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.
Interventions
BEHAVIORALIntervention
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.
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.
Sponsors
Laval University
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in muscle mass (bioimpedance scale) | Baseline to 6 months | Muscle mass (kg) |
| Changes in muscular function (handgrip strength) | Baseline to 6 months | Handgrip strength (kg) |
| Changes in muscular function (short physical performance battery) | Baseline to 6 months | Short physical performance battery (balance, gait speed, lower-limb strength). Minimum: 0; Maximum: 12, with lower scores indicating poorer physical performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in muscle mass (bioimpedance scale) | Baseline to 12 months | Muscle mass (kg) variation |
| Changes in muscular function (handgrip strength) | Baseline to 12 months | Handgrip strength (kg) |
| Changes in muscular function (short physical performance battery) | Baseline to 12 months | Short physical performance battery (balance, gait speed, lower-limb strength). Minimum: 0; Maximum: 12, with lower scores indicating poorer physical performance. |
| Changes in nutrional intakes (Web-based 24-hour dietary recall) | Baseline to 6 months and baseline to 12 months | Macro- and micro-nutrients intakes |
| Changes in diet quality (Web-based 24-hour dietary recall) | Baseline to 6 months and baseline to 12 months | Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100 |
| Changes in body composition (bioimpedance scale) | Baseline to 6 months and baseline to 12 months | Body weight (kg) fat mass (kg) |
| Changes in body mass index (bioimpedance scale) | Baseline to 6 months and baseline to 12 months | Body mass index (kg/m\^2) |
| Changes in visceral fat levels (bioimpedence scale) | Baseline to 6 months and baseline to 12 months | Visceral fat levels; Minimum: 1, Maximum: 20 |
| Changes in glycemic profiles (blood sample) | Baseline to 6 months and baseline to 12 months | Glycemia (mmol/L), insulinemia (mmol/L) |
| Changes in lipid profiles (blood sample) | Baseline to 6 months and baseline to 12 months | Total cholesterol (mmol/L), high density lipoprotein cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), triglycerides (mmol/L) |
| Changes in hemodynamic measurements (sphygmomanometer) | Baseline to 6 months and baseline to 12 months | Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg) |
| Changes in hepatic biomarkers (blood sample) | Baseline to 6 months and baseline to12 months | Blood biomarkers \[aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT)\] (UI/L) |
| Changes in hepatic steatosis (transcient elastography) | Baseline to 6 months and baseline to 12 months | Controlled attenuation parameter (CAP) score (dB/m) |
| Changes in hepatic fibrosis (transcient elastography) | Baseline to 6 months and baseline to 12 months | Liver stiffness (kPa) |
| Changes in physical activity participation (three-day physical activity record) | Baseline to 6 months and baseline to12 months | Three-day physical activity record (two week days and one weekend day), Minimum: 0, Maximum 9 |
| Changes in physical activity participation (step count) | Baseline to 6 months and baseline to 12 months | Seven-day step count |
| Changes in physical activity participation (exercise facility participation) | Baseline to 6 months and baseline to 12 months | Number of gym entries |
| Changes in eating behaviors (Adult Eating Behaviour Questionnaire) | Baseline to 6 months and baseline to 12 months | Evaluates eight appetite-related traits. Each trait has a score of 0-5 and the mean is calculated for every one of them. |
| Changes in well-being, mood and Quality of Life (QLaval) | Baseline to 12 months | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life. |
| Feasibility of care model (adherence) | Baseline to 6 months and baseline to 12 months | Adherence to follow-ups (high adherence: at least 75%) |
| Feasibility of care model (rentention) | Baseline to 6 months and baseline to 12 months | Percentage (%) of individuals completing the program |
| Feasibility of care model (satisfaction questionnaire) | Baseline to 6 months and baseline to 12 months | Questionnaire (Likert scale 1-5) |
Countries
Canada
Contacts
CONTACTElisa Marin-Couture, Kin, PhD
CONTACTMarianne Legault, DtP, MSc
PRINCIPAL_INVESTIGATORAndréanne Michaud, DtP, PhD
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
PRINCIPAL_INVESTIGATORFannie Lajeunesse-Trempe, MD PhD FRCPC
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Outcome results
None listed