Incretin-based Therapies, Nutrition, and Physical Activity (HARMONY)

February 6, 2026 updated by: Andréanne Michaud, Laval University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andréanne Michaud, DtP, PhD
        • Principal Investigator:
          • Fannie Lajeunesse-Trempe, MD PhD FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Medication alone
Participants will be randomly assigned to the incretin-based pharmacotherapy only.
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.
Experimental: Incretin-based pharmacotherapy combined with a 6-month lifestyle intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in muscle mass (bioimpedance scale)
Time Frame: Baseline to 6 months
Muscle mass (kg)
Baseline to 6 months
Changes in muscular function (handgrip strength)
Time Frame: Baseline to 6 months
Handgrip strength (kg)
Baseline to 6 months
Changes in muscular function (short physical performance battery)
Time Frame: 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.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in muscle mass (bioimpedance scale)
Time Frame: Baseline to 12 months
Muscle mass (kg) variation
Baseline to 12 months
Changes in muscular function (handgrip strength)
Time Frame: Baseline to 12 months
Handgrip strength (kg)
Baseline to 12 months
Changes in muscular function (short physical performance battery)
Time Frame: 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.
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
Macro- and micro-nutrients intakes
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
Healthy Eating Index (HEI) Score; Minimum: 0, Maximum: 100
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
Body weight (kg) fat mass (kg)
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
Body mass index (kg/m^2)
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
Visceral fat levels; Minimum: 1, Maximum: 20
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
Glycemia (mmol/L), insulinemia (mmol/L)
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
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)
Time Frame: Baseline to 6 months and baseline to 12 months
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)
Time Frame: Baseline to 6 months and baseline to12 months
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)
Time Frame: Baseline to 6 months and baseline to 12 months
Controlled attenuation parameter (CAP) score (dB/m)
Baseline to 6 months and baseline to 12 months
Changes in hepatic fibrosis (transcient elastography)
Time Frame: Baseline to 6 months and baseline to 12 months
Liver stiffness (kPa)
Baseline to 6 months and baseline to 12 months
Changes in physical activity participation (three-day physical activity record)
Time Frame: Baseline to 6 months and baseline to12 months
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)
Time Frame: Baseline to 6 months and baseline to 12 months
Seven-day step count
Baseline to 6 months and baseline to 12 months
Changes in physical activity participation (exercise facility participation)
Time Frame: Baseline to 6 months and baseline to 12 months
Number of gym entries
Baseline to 6 months and baseline to 12 months
Changes in eating behaviors (Adult Eating Behaviour Questionnaire)
Time Frame: 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.
Baseline to 6 months and baseline to 12 months
Changes in well-being, mood and Quality of Life (QLaval)
Time Frame: 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.
Baseline to 12 months
Feasibility of care model (adherence)
Time Frame: Baseline to 6 months and baseline to 12 months
Adherence to follow-ups (high adherence: at least 75%)
Baseline to 6 months and baseline to 12 months
Feasibility of care model (rentention)
Time Frame: Baseline to 6 months and baseline to 12 months
Percentage (%) of individuals completing the program
Baseline to 6 months and baseline to 12 months
Feasibility of care model (satisfaction questionnaire)
Time Frame: Baseline to 6 months and baseline to 12 months
Questionnaire (Likert scale 1-5)
Baseline to 6 months and baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-4477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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