ClinicalTrials.gg
Not yet recruitingNCT07836582Updated Sep 23, 2026

Physical Activity for Depressive Symptoms in Adults With Obesity: A Randomized Controlled Feasibility Trial

An interventional study of Supervised Physical Activity Program in Obesity & Overweight and Depression Disorders, sponsored by Universite du Quebec en Outaouais. Not yet recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Universite du Quebec en Outaouais · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 574 studies in Obesity with a site in Canada — 101 open to participants now, 150 under way, 46 of them phase 3. Obesity · Canada.

Planned enrollment
394th of 479
26 · median 73
Started
2027
with 1 other
No phase
280 of 574
34 open now
Primary completion
2027-12
later than 93 of 149 live
Registered
567th of 574
by date

Among the 574 studies in Obesity with a site in Canada, this one is the 394th largest by planned enrollment of the 479 interventional ones, is one of 2 that started in 2027, is one of 280 with no phase, reaches primary completion later than 93 of the 149 other live ones, and was the 567th registered.

By phase

574 studies; the count open now beside each. This study's row is marked.

No phasethis study280 · 34 open
Phase 392 · 27 open
Observational91 · 16 open
Phase 248 · 6 open
Phase 426 · 11 open
Phase 122 · 5 open
Phase 1/210 · 1 open
Phase 2/35 · 1 open

By the year they started

First in 1997; this study’s year is marked. 2 started in 2027.

Size and results

Median enrollment 73 across the 479 interventional studies, 52 across the 91 observational. Of the 362 that completed or were terminated, 48 (13%) have results posted.

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02

Study 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. 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
03

Conditions studied

  • Obesity & Overweight
  • Depression Disorders

Keywords

  • Obesity
  • Depression
  • Physical activity
  • Feasibility study
  • Randomized controlled trial
  • Ecological momentary assessment
  • Multicenter study
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Adult (≥ 18 years old)
  • (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

Exclusion criteria

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Absolute 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
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Physical Activity Intervention

    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.

    Other: Supervised Physical Activity Program

  • No intervention
    Usual Care

    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.

Interventions

  • OtherSupervised Physical Activity Program

    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.

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    Number of patients contacted per month for eligibility screening. Success threshold: ≥ 6 patients/month

    Time frame: Over the recruitment period (up to 9 months)

  2. Enrollment rate

    Number of participants enrolled in the study per month

    Time frame: Over the recruitment period (up to 9 months)

  3. Study refusal rate

    Percentage of eligible people who decline to participate

    Time frame: Over the recruitment period (up to 9 months)

  4. Eligibility rate

    Percentage of screened individuals who meet eligibility criteria

    Time frame: Over the recruitment period (up to 9 months)

  5. Randomization acceptance rate

    Percentage of eligible, consenting participants who accept randomization

    Time frame: At the time of enrollment

  6. Retention rate by group

    Percentage of participants retained in each study arm (target: ≥ 70%, per section 4.3)

    Time frame: From enrollment to the end of the intervention at 9 weeks

  7. Intervention participation rate

    Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)

    Time frame: Over the 9-week intervention period

  8. EMA item response adherence rate

    Percentage of completed ecological momentary assessment prompts on depressive symptoms (target: ≥ 60%, per section 4.3)

    Time frame: Over the 9-week intervention period

  9. 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

    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

Secondary outcomes

  1. Depressive symptom dynamics (EMA-MADRS)

    Ecological Momentary Assessment version of the Montgomery-Åsberg Depression Rating Scale (EMA-MADRS), administered via the BEIWE smartphone application

    Time frame: Continuously throughout the 9-week intervention period

  2. Depressive symptoms (Self report/CES-D)

    Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: At baseline and at 9 weeks (end of intervention)

  3. Depressive symptoms (clinician-rated/MADRS)

    Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: At baseline and at 9 weeks (end of intervention)

  4. Anxiety symptoms (GAD-7)

    Generalized Anxiety Disorder 7-item Scale (GAD-7)

    Time frame: At baseline and at 9 weeks (end of intervention)

  5. 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

    Time frame: At baseline and at 9 weeks (end of intervention)

  6. Body mass index

    Calculated from height and weight measured by a trained research assistant (kg/m²)

    Time frame: At baseline and at 9 weeks (end of intervention)

  7. 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)

    Time frame: At baseline and at 9 weeks (end of intervention)

  8. Physical activity and sedentary behavior

    Simple Physical Activity Questionnaire (SIMPAQ)

    Time frame: At baseline and at 9 weeks (end of intervention)

  9. Lifestyle habits

    Standardized self-reported questionnaire

    Time frame: At baseline

  10. Sociodemographic characteristics

    Standardized self-reported questionnaire

    Time frame: At baseline

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Dec 2027, 11 months later.

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 11 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.

Registered
Sep 17, 2026
First posted
Sep 23, 2026
StartEst.
Jan 2027
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07836582
Lead sponsor
Universite du Quebec en Outaouais
Collaborators
Institut du Savoir Montfort, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval, Université de Montréal
Responsible party
Aurelie Baillot (Full Professor, Universite du Quebec en Outaouais) — Principal investigator
First posted
Sep 23, 2026
Start date
Jan 2027 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Aurélie Baillot, Phd
Contact
aurelie.baillot@uqo.ca
819-595-3900 ext. 1995
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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