Obesity & OverweightNCT07836582
Physical Activity for Depressive Symptoms in Adults With Obesity: A Randomized Controlled Feasibility Trial
A study testing Supervised Physical Activity Program in people with Obesity & Overweight and Depression Disorders, run by Universite du Quebec en Outaouais at 3 sites in Canada.
Trial summary
The goal of this clinical trial is to learn whether a supervised physical activity program can be successfully carried out for adults living with obesity and depression, and whether people are willing to take part in this kind of research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Depression Disorders
- What is being tested?
- Supervised Physical Activity Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2027to Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥ 18 years old)
- Body mass index (BMI) ≥ 30 kg/m²
- Mild to moderate depressive symptoms (Montgomery-Åsberg Depression -Rating Scale [MADRS] score ≥ 7 and < 35)
- Less than 90 minutes of moderate physical activity per week
- Fewer than 2 structured physical activity sessions per week
Who cannot join
- Pregnant or breastfeeding
- Absolute contraindication to physical activity (as determined by the Get Active Questionnaire)
- Severe psychiatric comorbidity likely to interfere with participation or interpretation of results (bipolar affective disorder, schizoaffective disorder, schizophrenia, or severe post-traumatic stress disorder)
- Unstable treatment or symptoms: any change to background treatment (pharmacological and/or psychotherapeutic) within the past 3 months, OR unstable symptoms over the past 3 months if not on medication
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites
Université du Québec en Outaouais
Gatineau, Quebec, J8X3X7
Aurélie Baillot, Phd, 819-595-3900 ext. 1995, aurelie.baillot@uqo.ca
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Montreal, Quebec, H1N 3M5
Ahmed Jérôme Romain, Phd, 514-343-6111 ext. 3898, aj.romain@umontreal.ca
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V 4G5
Sylvain Iceta, Phd, 418-656-8711 ext. 5346, sylvain.iceta.1@ulaval.ca
About this study
Official title: Effects of Physical Activity on the Dynamics of Depressive Symptoms in People Living With Obesity and Depressive Disorder: A Randomized Controlled Feasibility Trial
The goal of this clinical trial is to learn whether a supervised physical activity program can be successfully carried out for adults living with obesity and depression, and whether people are willing to take part in this kind of research. The main questions it aims to answer are:
Can researchers recruit enough participants and keep them in the study? Will participants attend the physical activity sessions? Does physical activity change how depression symptoms are connected to each other over time?
Read more
Researchers expect that the study procedures and the physical activity program will be feasible and acceptable, based on goals set before the study began. Researchers also expect that physical activity will weaken the connections between depression symptoms over time and will lower depression symptoms overall. This second idea will be tested more fully in a future, larger trial.
Researchers will compare a supervised physical activity program to usual care to see whether the program can be delivered as planned and is acceptable to participants.
Participants will:
- Take part in a physical activity program led by a kinesiologist, twice a week for 9 weeks, or receive usual care plus information about physical activity and mental health support
- Have a health check-up before and after the program
- Answer short questions about their mood several times a day using a phone app
- Take part in an interview after the program ends
- Conditions
- Obesity & Overweight, Depression Disorders
- Being tested
- Supervised Physical Activity Program
- Keywords
- Obesity, Depression, Physical activity, Feasibility study, Randomized controlled trial, Ecological momentary assessment, Multicenter study
- Medical subject headings
- Obesity, Overweight, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Physical Activity ProgramOther
Participants will take part in an individually supervised physical activity program led by a trained kinesiologist, consisting of two 45-minute sessions per week for 9 weeks. The program will include aerobic activities (e.g., kickboxing, walking, running) and resistance exercises, selected based on each participant's preferences to support adherence. Participants will choose their preferred location (research center, community room, or outdoor park). Exercise intensity will be self-selected by participants during the first two weeks, then gradually progressed toward a moderate intensity target (50-60% of heart rate reserve), monitored using a heart rate monitor at each session.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Intervention | Experimental | Participants will take part in an individually supervised physical activity program led by a trained kinesiologist, consisting of two 45-minute sessions per week for 9 weeks. The program will include aerobic activities (e.g., kickboxing, walking, running) and resistance exercises, selected based on each participant's preferences to support adherence. Participants will choose their preferred location (research center, community room, or outdoor park). Exercise intensity will be self-selected by participants during the first two weeks, then gradually progressed toward a moderate intensity target (50-60% of heart rate reserve), monitored using a heart rate monitor at each session. Receives: Other: Supervised Physical Activity Program |
| Usual Care | No intervention | Participants will continue their usual care and will receive written documentation on the benefits of physical activity, along with information about community organizations offering physical activity and mental health resources. No supervised exercise program will be provided to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients contacted per month for eligibility screening. Success threshold: ≥ 6 patients/month
Measured: Over the recruitment period (up to 9 months)
Enrollment rate
Number of participants enrolled in the study per month
Measured: Over the recruitment period (up to 9 months)
Study refusal rate
Percentage of eligible people who decline to participate
Measured: Over the recruitment period (up to 9 months)
Eligibility rate
Percentage of screened individuals who meet eligibility criteria
Measured: Over the recruitment period (up to 9 months)
Randomization acceptance rate
Percentage of eligible, consenting participants who accept randomization
Measured: At the time of enrollment
Retention rate by group
Percentage of participants retained in each study arm (target: ≥ 70%, per section 4.3)
Measured: From enrollment to the end of the intervention at 9 weeks
Intervention participation rate
Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)
Measured: Over the 9-week intervention period
EMA item response adherence rate
Percentage of completed ecological momentary assessment prompts on depressive symptoms (target: ≥ 60%, per section 4.3)
Measured: Over the 9-week intervention period
Intervention acceptability
Assessed using a study-specific questionnaire (anticipated acceptability at T1, retrospective acceptability at T2) and semi-structured individual interviews conducted online via Zoom, based on an established acceptability framework
Measured: At enrollment, at the end of the intervention (9 weeks), and during a follow-up interview within 4 weeks after the intervention ends
Secondary outcomes (10)
Depressive symptom dynamics (EMA-MADRS)
Ecological Momentary Assessment version of the Montgomery-Åsberg Depression Rating Scale (EMA-MADRS), administered via the BEIWE smartphone application
Measured: Continuously throughout the 9-week intervention period
Depressive symptoms (Self report/CES-D)
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: At baseline and at 9 weeks (end of intervention)
Depressive symptoms (clinician-rated/MADRS)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: At baseline and at 9 weeks (end of intervention)
Anxiety symptoms (GAD-7)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Measured: At baseline and at 9 weeks (end of intervention)
Physical condition (6-minute walk test)
Distance walked (in meters) during a standardized 6-minute walk test on a 30-meter corridor, administered according to the American Thoracic Society protocol
Measured: At baseline and at 9 weeks (end of intervention)
Body mass index
Calculated from height and weight measured by a trained research assistant (kg/m²)
Measured: At baseline and at 9 weeks (end of intervention)
Waist circumference
Measured twice above the iliac crest using a measuring tape by a trained research assistant; the average of the two measurements is used (cm)
Measured: At baseline and at 9 weeks (end of intervention)
Physical activity and sedentary behavior
Simple Physical Activity Questionnaire (SIMPAQ)
Measured: At baseline and at 9 weeks (end of intervention)
Lifestyle habits
Standardized self-reported questionnaire
Measured: At baseline
Sociodemographic characteristics
Standardized self-reported questionnaire
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite du Quebec en Outaouais
- Sponsor type
- University, hospital or other
- Collaborators
- Institut du Savoir Montfort, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Université de Montréal
- Responsible party
- Principal investigator, Aurelie Baillot, Universite du Quebec en Outaouais
- Investigators
- Ahmed Jérôme Romain, Phd, Principal investigator, Institut de santé mentale de Montréal/UdMSylvain Iceta, Phd, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836582
- Sponsor's protocol ID
- 2026-002- OBÉSITÉ TD
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Activity on the Dynamics of Depressive Symptoms in People Living With Obesity and Depressive Disorder: A Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07836582
- Acronym / sponsor ID
- 2026-002- OBÉSITÉ TD
- Conditions
- Obesity & Overweight, Depression Disorders
- Keywords
- Obesity, Depression, Physical activity, Feasibility study, Randomized controlled trial, Ecological momentary assessment, Multicenter study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Universite du Quebec en OutaouaisUniversity, hospital or other
- Collaborators
- Institut du Savoir Montfort, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Université de Montréal
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Sep 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 learn whether a supervised physical activity program can be successfully carried out for adults living with obesity and depression, and whether people are willing to take part in this kind of research. The main questions it aims to answer are:
Can researchers recruit enough participants and keep them in the study? Will participants attend the physical activity sessions? Does physical activity change how depression symptoms are connected to each other over time?
Researchers expect that the study procedures and the physical activity program will be feasible and acceptable, based on goals set before the study began. Researchers also expect that physical activity will weaken the connections between depression symptoms over time and will lower depression symptoms overall. This second idea will be tested more fully in a future, larger trial.
Researchers will compare a supervised physical activity program to usual care to see whether the program can be delivered as planned and is acceptable to participants.
Participants will:
- Take part in a physical activity program led by a kinesiologist, twice a week for 9 weeks, or receive usual care plus information about physical activity and mental health support
- Have a health check-up before and after the program
- Answer short questions about their mood several times a day using a phone app
- Take part in an interview after the program ends
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Intervention | Experimental | Other: Supervised Physical Activity ProgramParticipants will take part in an individually supervised physical activity program led by a trained kinesiologist, consisting of two 45-minute sessions per week for 9 weeks. The program will include aerobic activities (e.g., kickboxing, walking, running) and resistance exercises, selected based on each participant's preferences to support adherence. Participants will choose their preferred location (research center, community room, or outdoor park). Exercise intensity will be self-selected by participants during the first two weeks, then gradually progressed toward a moderate intensity target (50-60% of heart rate reserve), monitored using a heart rate monitor at each session. |
| Usual Care | No intervention | –Participants will continue their usual care and will receive written documentation on the benefits of physical activity, along with information about community organizations offering physical activity and mental health resources. No supervised exercise program will be provided to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (≥ 18 years old)
- Body mass index (BMI) ≥ 30 kg/m²
- Mild to moderate depressive symptoms (Montgomery-Åsberg Depression -Rating Scale [MADRS] score ≥ 7 and < 35)
- Less than 90 minutes of moderate physical activity per week
- Fewer than 2 structured physical activity sessions per week
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- Absolute contraindication to physical activity (as determined by the Get Active Questionnaire)
- Severe psychiatric comorbidity likely to interfere with participation or interpretation of results (bipolar affective disorder, schizoaffective disorder, schizophrenia, or severe post-traumatic stress disorder)
- Unstable treatment or symptoms: any change to background treatment (pharmacological and/or psychotherapeutic) within the past 3 months, OR unstable symptoms over the past 3 months if not on medication
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 |
|---|---|---|
| Supervised Physical Activity ProgramParticipants will take part in an individually supervised physical activity program led by a trained kinesiologist, consisting of two 45-minute sessions per week for 9 weeks. The program will include aerobic activities (e.g., kickboxing, walking, running) and resistance exercises, selected based on each participant's preferences to support adherence. Participants will choose their preferred location (research center, community room, or outdoor park). Exercise intensity will be self-selected by participants during the first two weeks, then gradually progressed toward a moderate intensity target (50-60% of heart rate reserve), monitored using a heart rate monitor at each session. | Other | Physical Activity Intervention |
Primary outcome
Recruitment rate
Time frame: Over the recruitment period (up to 9 months)
Number of patients contacted per month for eligibility screening. Success threshold: ≥ 6 patients/month
Enrollment rate
Time frame: Over the recruitment period (up to 9 months)
Number of participants enrolled in the study per month
Study refusal rate
Time frame: Over the recruitment period (up to 9 months)
Percentage of eligible people who decline to participate
Eligibility rate
Time frame: Over the recruitment period (up to 9 months)
Percentage of screened individuals who meet eligibility criteria
Randomization acceptance rate
Time frame: At the time of enrollment
Percentage of eligible, consenting participants who accept randomization
Retention rate by group
Time frame: From enrollment to the end of the intervention at 9 weeks
Percentage of participants retained in each study arm (target: ≥ 70%, per section 4.3)
Intervention participation rate
Time frame: Over the 9-week intervention period
Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)
EMA item response adherence rate
Time frame: Over the 9-week intervention period
Percentage of completed ecological momentary assessment prompts on depressive symptoms (target: ≥ 60%, per section 4.3)
Intervention acceptability
Time frame: At enrollment, at the end of the intervention (9 weeks), and during a follow-up interview within 4 weeks after the intervention ends
Assessed using a study-specific questionnaire (anticipated acceptability at T1, retrospective acceptability at T2) and semi-structured individual interviews conducted online via Zoom, based on an established acceptability framework
10 secondary outcomes
Depressive symptom dynamics (EMA-MADRS)
Time frame: Continuously throughout the 9-week intervention period
Depressive symptoms (Self report/CES-D)
Time frame: At baseline and at 9 weeks (end of intervention)
Depressive symptoms (clinician-rated/MADRS)
Time frame: At baseline and at 9 weeks (end of intervention)
Anxiety symptoms (GAD-7)
Time frame: At baseline and at 9 weeks (end of intervention)
Physical condition (6-minute walk test)
Time frame: At baseline and at 9 weeks (end of intervention)
Body mass index
Time frame: At baseline and at 9 weeks (end of intervention)
Waist circumference
Time frame: At baseline and at 9 weeks (end of intervention)
Physical activity and sedentary behavior
Time frame: At baseline and at 9 weeks (end of intervention)
Lifestyle habits
Time frame: At baseline
Sociodemographic characteristics
Time frame: At baseline
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 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Ahmed Jérôme Romain, Phd principal investigator
Institut de santé mentale de Montréal/UdM
Sylvain Iceta, Phd principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Physical Activity Program in people with Obesity & Overweight and Depression Disorders, run by Universite du Quebec en Outaouais at 3 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 Aurélie Baillot, Phd (819-595-3900 ext. 1995, aurelie.baillot@uqo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Over the recruitment period (up to 9 months)). The study lists 9 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 23 Sep 2026.