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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
26
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.
Université du Québec en Outaouais
Gatineau, Quebec, Canada
Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Montreal, Quebec, Canada
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec, Quebec, Canada
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)
Enrollment rate
Number of participants enrolled in the study per month
Time frame: Over the recruitment period (up to 9 months)
Study refusal rate
Percentage of eligible people who decline to participate
Time frame: Over the recruitment period (up to 9 months)
Eligibility rate
Percentage of screened individuals who meet eligibility criteria
Time frame: Over the recruitment period (up to 9 months)
Randomization acceptance rate
Percentage of eligible, consenting participants who accept randomization
Time frame: At the time of enrollment
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
Intervention participation rate
Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)
Time frame: 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)
Time frame: 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
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
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
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)
Depressive symptoms (clinician-rated/MADRS)
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: At baseline and at 9 weeks (end of intervention)
Anxiety symptoms (GAD-7)
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: At baseline and at 9 weeks (end of intervention)
Physical activity and sedentary behavior
Simple Physical Activity Questionnaire (SIMPAQ)
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Time frame: At baseline and at 9 weeks (end of intervention)
Lifestyle habits
Standardized self-reported questionnaire
Time frame: At baseline
Sociodemographic characteristics
Standardized self-reported questionnaire
Time frame: At baseline