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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversite du Quebec en Outaouais

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Supervised Physical Activity Program

    Other 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.

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Physical Activity InterventionExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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)

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universite du Quebec en Outaouais

Lead sponsor

Institut du Savoir Montfort

Collaborator

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

Collaborator

Université de Montréal

Collaborator

This trial is not recruiting at the moment. You can still explore other options: