Obesity & OverweightHARMONYNCT07409831
Incretin-based Therapies, Nutrition, and Physical Activity
A study testing Intervention and Incretin-Based Treatment in people with Obesity & Overweight and Cardiometabolic Conditions, run by Laval University at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity & Overweight, Cardiometabolic Conditions
- What is being tested?
- Intervention and Incretin-Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Jul 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
Elisa Marin-Couture, Kin, PhD, 1-418-656-8711 ext. 6103, equipe_flt@criucpq.ulaval.ca
Marianne Legault, DtP, MSc, 1-418-656-8711 ext. 6103, equipe_flt@criucpq.ulaval.ca
- Recruiting
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
Elisa Marin-Couture, PhD, 418-656-8711 ext. 6103, equipe_flt@criucpq.ulaval.ca
About this study
Official title: 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.
- Conditions
- Obesity & Overweight, Cardiometabolic Conditions
- Being tested
- Intervention, Incretin-Based Treatment
- Keywords
- Obesity, Incretin-Based Therapies, Physical Activity, Eating Behaviour, Lifestyle Intervention
- Medical subject headings
- Obesity, Overweight, Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
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.
Incretin-Based TreatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication alone | Placebo comparator | Participants will be randomly assigned to the incretin-based pharmacotherapy only. Receives: Drug: Incretin-Based Treatment |
| 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) Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg)
Measured: Baseline to 6 months
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Measured: 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.
Measured: Baseline to 6 months
Secondary outcomes (22)
Changes in muscle mass (bioimpedance scale)
Muscle mass (kg) variation
Measured: Baseline to 12 months
Changes in muscular function (handgrip strength)
Handgrip strength (kg)
Measured: 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.
Measured: Baseline to 12 months
Changes in nutrional intakes (Web-based 24-hour dietary recall)
Macro- and micro-nutrients intakes
Measured: 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
Measured: Baseline to 6 months and baseline to 12 months
Changes in body composition (bioimpedance scale)
Body weight (kg) fat mass (kg)
Measured: Baseline to 6 months and baseline to 12 months
Changes in body mass index (bioimpedance scale)
Body mass index (kg/m^2)
Measured: Baseline to 6 months and baseline to 12 months
Changes in visceral fat levels (bioimpedence scale)
Visceral fat levels; Minimum: 1, Maximum: 20
Measured: Baseline to 6 months and baseline to 12 months
Changes in glycemic profiles (blood sample)
Glycemia (mmol/L), insulinemia (mmol/L)
Measured: 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)
Measured: Baseline to 6 months and baseline to 12 months
Changes in hemodynamic measurements (sphygmomanometer)
Systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg)
Measured: 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)
Measured: Baseline to 6 months and baseline to12 months
Changes in hepatic steatosis (transcient elastography)
Controlled attenuation parameter (CAP) score (dB/m)
Measured: Baseline to 6 months and baseline to 12 months
Changes in hepatic fibrosis (transcient elastography)
Liver stiffness (kPa)
Measured: 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
Measured: Baseline to 6 months and baseline to12 months
Changes in physical activity participation (step count)
Seven-day step count
Measured: Baseline to 6 months and baseline to 12 months
Changes in physical activity participation (exercise facility participation)
Number of gym entries
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Feasibility of care model (adherence)
Adherence to follow-ups (high adherence: at least 75%)
Measured: Baseline to 6 months and baseline to 12 months
Feasibility of care model (rentention)
Percentage (%) of individuals completing the program
Measured: Baseline to 6 months and baseline to 12 months
Feasibility of care model (satisfaction questionnaire)
Questionnaire (Likert scale 1-5)
Measured: Baseline to 6 months and baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start6 Jul 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Andréanne Michaud, Laval University
- Investigators
- Andréanne Michaud, DtP, PhD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University LavalFannie Lajeunesse-Trempe, MD PhD FRCPC, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409831
- Sponsor's protocol ID
- 2026-4477
- Acronym
- HARMONY
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Approach to Cardiometabolic Health and Obesity: Incretin-based Therapies, Nutrition, and Active Lifestyle
- ClinicalTrials.gov ID
- NCT07409831
- Acronym / sponsor ID
- HARMONY / 2026-4477
- Conditions
- Obesity & Overweight, Cardiometabolic Conditions
- Keywords
- Obesity, Incretin-Based Therapies, Physical Activity, Eating Behaviour, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication alone | Placebo comparator | Drug: Incretin-Based TreatmentParticipants will be randomly assigned to the incretin-based pharmacotherapy only. |
| Incretin-based pharmacotherapy combined with a 6-month lifestyle intervention | Experimental | Behavioral: InterventionThe 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionParticipants 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. | Behavioural | Incretin-based pharmacotherapy combined with a 6-month lifestyle intervention |
| Incretin-Based TreatmentParticipants 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. | Drug | Medication alone |
Primary outcome
Changes in muscle mass (bioimpedance scale)
Time frame: Baseline to 6 months
Muscle mass (kg)
Changes in muscular function (handgrip strength)
Time frame: Baseline to 6 months
Handgrip strength (kg)
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.
22 secondary outcomes
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
Changes in hepatic steatosis (transcient elastography)
Time frame: 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
Changes in physical activity participation (three-day physical activity record)
Time frame: 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
Changes in physical activity participation (exercise facility participation)
Time frame: 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
Changes in well-being, mood and Quality of Life (QLaval)
Time frame: Baseline to 12 months
Feasibility of care model (adherence)
Time frame: 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
Feasibility of care model (satisfaction questionnaire)
Time frame: Baseline to 6 months and baseline to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andréanne Michaud, DtP, PhD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Fannie Lajeunesse-Trempe, MD PhD FRCPC principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention and Incretin-Based Treatment in people with Obesity & Overweight and Cardiometabolic Conditions, run by Laval University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisa Marin-Couture, Kin, PhD (1-418-656-8711 ext. 6103, elisa.marin-couture.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in muscle mass (bioimpedance scale) (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.