Sleep & Exercise Intervention for Obesity
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a thyroid condition, it must be currently treated to participate.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the idea that Sleep & Exercise Intervention for Obesity is an effective treatment?
The available research shows that combining sleep management with exercise can be effective for obesity. For example, a study called 'The better weight-better sleep study' explored how integrating sleep and exercise interventions could help manage obesity. Additionally, another study found that a program combining physical activity counseling with sleep therapy improved sleep in people with chronic insomnia. This suggests that similar approaches could be beneficial for obesity. Furthermore, a study on aerobic exercise showed improved sleep quality in overweight and obese men with insomnia, indicating that exercise can positively impact sleep and potentially aid in weight management.12345
What data supports the effectiveness of the Sleep and Physical Activity Intervention, Sleep Extension Intervention, Physical Activity Intervention, and Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment for obesity?
Research shows that combining sleep management with diet and exercise can be effective for obesity, as seen in a study integrating these elements in a 12-week trial. Additionally, increasing physical activity and improving sleep quality have shown benefits for people with chronic insomnia and sleep apnea, which are often related to obesity.12345
What safety data exists for the Sleep & Exercise Intervention for Obesity?
The safety data for treatments similar to the Sleep & Exercise Intervention for Obesity, such as Cognitive Behavioral Therapy for Insomnia (CBT-I) and physical activity interventions, is limited. A systematic review found that only 32.3% of CBT-I trials addressed adverse events, and only 7.1% met all criteria for adequate reporting. There is no consistent evidence of adverse events between trial arms, but the lack of comprehensive monitoring and reporting makes it difficult to draw clear conclusions. Additionally, while exercise is suggested as a beneficial adjunct to CBT-I, its combined effects have not been explored in clinical trials.36789
Is the Sleep & Exercise Intervention for Obesity safe for humans?
Cognitive Behavioral Therapy for Insomnia (CBT-I), a component of the intervention, is generally considered safe, but studies show limited attention to adverse events, making it hard to draw clear conclusions. Exercise, another component, is known for positive effects on insomnia, but its combination with CBT-I hasn't been fully explored in clinical trials.36789
Is the Sleep and Physical Activity Intervention a promising treatment for obesity?
Yes, the Sleep and Physical Activity Intervention is promising for obesity. It combines sleep management, exercise, and therapy to improve sleep quality and help manage weight. Exercise can enhance sleep and reduce cravings for unhealthy foods, while therapy can help with sleep issues. Together, these approaches can improve overall health and quality of life for people with obesity.1261011
How is the Sleep and Physical Activity Intervention treatment for obesity different from other treatments?
This treatment is unique because it combines sleep management, physical activity, and cognitive behavioral therapy for insomnia (CBT-I) to address obesity, unlike traditional treatments that may focus solely on diet or exercise. By integrating these components, it aims to improve sleep quality and physical activity, which can help manage weight more effectively.1261011
What is the purpose of this trial?
This trial studies how online sessions to improve sleep and increase physical activity can help overweight or obese and sedentary African American adults. Better sleep may boost energy and motivation for exercise, while coaching offers practical tips for healthier living.
Research Team
Lorna McNeill
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for overweight or obese African American adults who are sedentary, sleep less than 6 hours a night, and have internet access. They must be able to do moderate exercise (cleared by a questionnaire or doctor) but not currently in a weight management program, without untreated thyroid issues, severe depression risk, high caffeine intake, or plans to move from Houston soon.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Focus Groups and Interviews
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems
Intervention
Participants receive a web-based sleep intervention and health coaching sessions, or educational material and counseling sessions
Follow-up
Participants are monitored for changes in sleep, physical activity, and sedentary behavior
Treatment Details
Interventions
- Sleep and Physical Activity Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator