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NCT Number: NCT07836582

Physical Activity for Depressive Symptoms in Adults With Obesity: 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?

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

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Key information

Conditions

Obesity & Overweight Behavior Behavioral Symptoms Body Weight Depression Depression Disorders Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université du Québec en Outaouais, Gatineau, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Supervised Physical Activity Program

Other

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.

Primary outcomes

  1. 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

  2. Enrollment rate

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

    Number of participants enrolled in the study per month

  3. Study refusal rate

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

    Percentage of eligible people who decline to participate

  4. Eligibility rate

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

    Percentage of screened individuals who meet eligibility criteria

  5. Randomization acceptance rate

    Time frame: At the time of enrollment

    Percentage of eligible, consenting participants who accept randomization

  6. 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)

  7. Intervention participation rate

    Time frame: Over the 9-week intervention period

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

  8. 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)

  9. 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

Secondary outcomes

  1. Depressive symptom dynamics (EMA-MADRS)

    Time frame: Continuously throughout the 9-week intervention period

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

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

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

    Center for Epidemiologic Studies Depression Scale (CES-D)

  3. Depressive symptoms (clinician-rated/MADRS)

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

    Montgomery-Åsberg Depression Rating Scale (MADRS)

  4. Anxiety symptoms (GAD-7)

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

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

  5. Physical condition (6-minute walk test)

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

    Distance walked (in meters) during a standardized 6-minute walk test on a 30-meter corridor, administered according to the American Thoracic Society protocol

  6. Body mass index

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

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

  7. Waist circumference

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

    Measured twice above the iliac crest using a measuring tape by a trained research assistant; the average of the two measurements is used (cm)

  8. Physical activity and sedentary behavior

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

    Simple Physical Activity Questionnaire (SIMPAQ)

  9. Lifestyle habits

    Time frame: At baseline

    Standardized self-reported questionnaire

  10. Sociodemographic characteristics

    Time frame: At baseline

    Standardized self-reported questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie Baillot, Phd

CONTACT

[email protected]

819-595-3900 ext. 1995

Sponsors and collaborators

Lead sponsor

Universite du Quebec en Outaouais

Other

Collaborators

  • Institut du Savoir Montfort
  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
  • Université de Montréal

Registry information

Official study title

Effects of Physical Activity on the Dynamics of Depressive Symptoms in People Living With Obesity and Depressive Disorder: A Randomized Controlled Feasibility Trial

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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