An interventional study of Intervention and Incretin-Based Treatment in Obesity & Overweight and Cardiometabolic Conditions, sponsored by Laval University. Recruiting at 2 sites in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Laval University · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 120 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Laval University is the lead sponsor of 380 studies on the registry; 67 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be randomly assigned to the incretin-based pharmacotherapy only.
Drug: Incretin-Based Treatment
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
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.
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg)
Time frame: Baseline to 6 months
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Time frame: 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.
Time frame: Baseline to 6 months
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg) variation
Time frame: Baseline to 12 months
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Time frame: 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.
Time frame: Baseline to 12 months
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 months
Changes in diet quality (Web-based 24-hour dietary recall)
Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100
Time frame: Baseline to 6 months and baseline to 12 months
Changes in body composition (bioimpedance scale)
Body weight (kg) fat mass (kg)
Time frame: Baseline to 6 months and baseline to 12 months
Changes in body mass index (bioimpedance scale)
Body mass index (kg/m\^2)
Time frame: Baseline to 6 months and baseline to 12 months
Changes in visceral fat levels (bioimpedence scale)
Visceral fat levels; Minimum: 1, Maximum: 20
Time frame: Baseline to 6 months and baseline to 12 months
Changes in glycemic profiles (blood sample)
Glycemia (mmol/L), insulinemia (mmol/L)
Time frame: 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)
Time frame: Baseline to 6 months and baseline to 12 months
Changes in hemodynamic measurements (sphygmomanometer)
Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg)
Time frame: 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)
Time frame: Baseline to 6 months and baseline to12 months
Changes in hepatic steatosis (transcient elastography)
Controlled attenuation parameter (CAP) score (dB/m)
Time frame: Baseline to 6 months and baseline to 12 months
Changes in hepatic fibrosis (transcient elastography)
Liver stiffness (kPa)
Time frame: 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
Time frame: Baseline to 6 months and baseline to12 months
Changes in physical activity participation (step count)
Seven-day step count
Time frame: Baseline to 6 months and baseline to 12 months
Changes in physical activity participation (exercise facility participation)
Number of gym entries
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 12 months
Feasibility of care model (adherence)
Adherence to follow-ups (high adherence: at least 75%)
Time frame: Baseline to 6 months and baseline to 12 months
Feasibility of care model (rentention)
Percentage (%) of individuals completing the program
Time frame: Baseline to 6 months and baseline to 12 months
Feasibility of care model (satisfaction questionnaire)
Questionnaire (Likert scale 1-5)
Time frame: Baseline to 6 months and baseline to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 20 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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