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| Name | Class |
|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | OTHER |
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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 QuĂ©bec - UniversitĂ© 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication alone | Placebo Comparator | Participants will be randomly assigned to the incretin-based pharmacotherapy only. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscle mass (bioimpedance scale) | Muscle mass (kg) variation | Baseline to 12 months |
| Changes in muscular function (handgrip strength) | Handgrip strength (kg) |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisa Marin-Couture, Kin, PhD | Contact | 1-418-656-8711 | 6103 | elisa.marin-couture.1@ulaval.ca |
| Marianne Legault, DtP, MSc | Contact | 1-418-656-8711 | 6103 | marianne.legault.2@ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Québec | Quebec | G1V 4G5 | Canada |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| 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. |
|
| Baseline to 12 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 12 months |
| Changes in nutrional intakes (Web-based 24-hour dietary recall) | Macro- and micro-nutrients intakes | Baseline to 6 months and baseline to 12 months |
| Changes in diet quality (Web-based 24-hour dietary recall) | Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100 | Baseline to 6 months and baseline to 12 months |
| Changes in body composition (bioimpedance scale) | Body weight (kg) fat mass (kg) | Baseline to 6 months and baseline to 12 months |
| Changes in body mass index (bioimpedance scale) | Body mass index (kg/m^2) | Baseline to 6 months and baseline to 12 months |
| Changes in visceral fat levels (bioimpedence scale) | Visceral fat levels; Minimum: 1, Maximum: 20 | Baseline to 6 months and baseline to 12 months |
| Changes in glycemic profiles (blood sample) | Glycemia (mmol/L), insulinemia (mmol/L) | Baseline to 6 months and baseline to 12 months |
| Changes in lipid profiles (blood sample) | Total cholesterol (mmol/L), high density lipoprotein cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), triglycerides (mmol/L) | Baseline to 6 months and baseline to 12 months |
| Changes in hemodynamic measurements (sphygmomanometer) | Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg) | Baseline to 6 months and baseline to 12 months |
| Changes in hepatic biomarkers (blood sample) | Blood biomarkers [aminotransferase (AST), alanine aminotransferase (ALT), and gamma-glutamyl transferase (GGT)] (UI/L) | Baseline to 6 months and baseline to12 months |
| Changes in hepatic steatosis (transcient elastography) | Controlled attenuation parameter (CAP) score (dB/m) | Baseline to 6 months and baseline to 12 months |
| Changes in hepatic fibrosis (transcient elastography) | Liver stiffness (kPa) | Baseline to 6 months and baseline to 12 months |
| Changes in physical activity participation (three-day physical activity record) | Three-day physical activity record (two week days and one weekend day), Minimum: 0, Maximum 9 | Baseline to 6 months and baseline to12 months |
| Changes in physical activity participation (step count) | Seven-day step count | Baseline to 6 months and baseline to 12 months |
| Changes in physical activity participation (exercise facility participation) | Number of gym entries | Baseline to 6 months and baseline to 12 months |
| Changes in eating behaviors (Adult Eating Behaviour Questionnaire) | Evaluates eight appetite-related traits. Each trait has a score of 0-5 and the mean is calculated for every one of them. | Baseline to 6 months and baseline to 12 months |
| Changes in well-being, mood and Quality of Life (QLaval) | Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7, higher scores indicate better quality of life. | Baseline to 12 months |
| Feasibility of care model (adherence) | Adherence to follow-ups (high adherence: at least 75%) | Baseline to 6 months and baseline to 12 months |
| Feasibility of care model (rentention) | Percentage (%) of individuals completing the program | Baseline to 6 months and baseline to 12 months |
| Feasibility of care model (satisfaction questionnaire) | Questionnaire (Likert scale 1-5) | Baseline to 6 months and baseline to 12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001522 | Behavior, Animal |