Effects of Physical Activity on the Dynamics of Depressive Symptoms in People Living With Obesity and Depressive Disorder: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Recruitment rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Supervised Physical Activity Program (Other)
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.
结局指标
主要结局
Recruitment rate
时间窗: Over the recruitment period (up to 9 months)
Number of patients contacted per month for eligibility screening. Success threshold: ≥ 6 patients/month
Enrollment rate
时间窗: Over the recruitment period (up to 9 months)
Number of participants enrolled in the study per month
Eligibility rate
时间窗: Over the recruitment period (up to 9 months)
Percentage of screened individuals who meet eligibility criteria
Study refusal rate
时间窗: Over the recruitment period (up to 9 months)
Percentage of eligible people who decline to participate
Randomization acceptance rate
时间窗: At the time of enrollment
Percentage of eligible, consenting participants who accept randomization
Retention rate by group
时间窗: 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
时间窗: Over the 9-week intervention period
Percentage of prescribed physical activity sessions attended (target: ≥ 80%, per section 4.3)
EMA item response adherence rate
时间窗: Over the 9-week intervention period
Percentage of completed ecological momentary assessment prompts on depressive symptoms (target: ≥ 60%, per section 4.3)
Intervention acceptability
时间窗: 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
次要结局
- Depressive symptom dynamics (EMA-MADRS)(Continuously throughout the 9-week intervention period)
- Depressive symptoms (Self report/CES-D)(At baseline and at 9 weeks (end of intervention))
- Depressive symptoms (clinician-rated/MADRS)(At baseline and at 9 weeks (end of intervention))
- Anxiety symptoms (GAD-7)(At baseline and at 9 weeks (end of intervention))
- Physical condition (6-minute walk test)(At baseline and at 9 weeks (end of intervention))
- Body mass index(At baseline and at 9 weeks (end of intervention))
- Waist circumference(At baseline and at 9 weeks (end of intervention))
- Physical activity and sedentary behavior(At baseline and at 9 weeks (end of intervention))
- Lifestyle habits(At baseline)
- Sociodemographic characteristics(At baseline)
研究者
Aurelie Baillot
Full Professor
Universite du Quebec en Outaouais