Sleep & Exercise Intervention for Obesity
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Waitlist Available
Sponsor: M.D. Anderson Cancer Center
No Placebo Group
Trial Summary
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.
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.1361011
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.258911
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.12347
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.
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
My BMI is 25 or higher, indicating I am overweight or obese.
I am cleared by my doctor to do moderate exercise.
Exclusion Criteria
I work night shifts or travel across time zones for work weekly.
I have a sleep disorder like insomnia or sleep apnea.
I have a thyroid condition diagnosed by a doctor but am not receiving treatment for it.
Treatment Details
The study tests if interventions focused on improving sleep and increasing physical activity can help sedentary African Americans become more active. Participants will engage in focus groups, health education sessions, online activities, interviews and fill out questionnaires.
4Treatment groups
Experimental Treatment
Active Control
Group I: Group II (health coaching session, sleep intervention)Experimental Treatment3 Interventions
Participants receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 1-4. Participants then receive a web-based sleep intervention weekly during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
Group II: Group I (sleep intervention, health coaching session)Experimental Treatment3 Interventions
Participants receive a web-based sleep intervention weekly during weeks 1-4. Participants then receive 2 web-based health coaching sessions over 30-45 minutes consisting of topics such as healthy shopping, increasing physical activity, identifying barriers, and eating out during weeks 5-9. Participants may optionally complete an interview over 1 hour at week 9.
Group III: Focus group and interview (focus group, interview)Experimental Treatment3 Interventions
Participants attend either a focus group or interview about the sleep intervention and sleep-related problems over 90 minutes.
Group IV: Group III (health education material, counseling session)Active Control4 Interventions
Participants receive educational material on healthy homes. Participants also receive 2 web-based counseling sessions over 30-45 minutes consisting of topics such as indoor air quality, CPR and first aid, and emergency preparedness at weeks 1 and 3. Participants may optionally complete an interview over 1 hour at week 9.
Find a clinic near you
Research locations nearbySelect from list below to view details:
The Univeristy of Texas M. D. Anderson Cancer CenterHouston, TX
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
The better weight-better sleep study: a pilot intervention in primary care. [2018]To explore the feasibility of integrating sleep management interventions with dietary and exercise interventions for obesity in a 12-week randomized trial.
Efficacy of physical activity counseling plus sleep restriction therapy on the patients with chronic insomnia. [2020]Lack of physical activity (PA) is common in patients with chronic insomnia. Studies to increase PA and decrease sedentary behavior in those patients are limited. Therefore, we investigated the efficacy of "PA counseling combined with sleep restriction (SR) therapy (PASR)" vs only SR in the patients with chronic insomnia.
Effects of aerobic exercise on home-based sleep among overweight and obese men with chronic insomnia symptoms: a randomized controlled trial. [2022]To determine the effect of a six-month aerobic exercise program on home-based sleep quality among overweight and obese men with chronic insomnia symptoms.
Bidirectional Relationships Between Weight Change and Sleep Apnea in a Behavioral Weight Loss Intervention. [2023]To examine the bidirectional relationship between weight change and obstructive sleep apnea (OSA) in the context of a behavioral weight loss intervention.
Sleep Outcomes With Cognitive Behavioral Therapy for Insomnia Are Similar Between Older Adults With Low vs. High Self-Reported Physical Activity. [2020]We examined whether baseline self-reported physical activity is associated with the efficacy of cognitive behavioral therapy for insomnia (CBT-I) in older veterans. Community-dwelling veterans aged 60 years and older with insomnia received CBT-I in a randomized controlled trial. Participants who received active treatment were divided into low and high physical activity based on self-report. Sleep outcomes were measured by sleep diary, questionnaire and wrist actigraphy; collected at baseline, post-treatment, 6-month and 12-month follow-up. Mixed-effects models compared differences between physical activity groups in change in sleep outcome from baseline to each follow-up, and equivalence tests examined if physical activity groups were clinically equal. There were no significant differences in sleep outcomes between physical activity groups. Equivalence tests suggested possible equality in physical activity groups for five of seven sleep outcomes. Efficacy of CBT-I in older veterans was not associated with self-reported physical activity at baseline. Older adults with insomnia who report low levels of physical activity can benefit from CBT-I.
Acute intense exercise improves sleep and decreases next morning consumption of energy-dense food in adolescent girls with obesity and evening chronotype. [2020]Although adolescence and obesity are related to impaired sleep duration and quality, exercise was admitted as a nonpharmacological treatment for sleep and better control of energy balance.
Effects on obstructive sleep apnea severity following a tailored behavioral sleep medicine intervention aimed at increased physical activity and sound eating: an 18-month follow-up of a randomized controlled trial. [2021]Positive effects have been reported following a behavioral sleep medicine (BSM) intervention targeting physical activity and eating behavior in addition to continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA). Long-term follow-up remains to be explored. The aim was to examine the long-term effects of a tailored BSM intervention addressing physical activity and eating behavior in addition to CPAP treatment in patients with moderate to severe OSA combined with overweight and physical inactivity. Further, the aim was to identify variables at baseline, associated with treatment success regarding OSA severity.
Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]Adverse events are undesirable events that can occur during medical or psychological treatment. There has been limited attention to adverse events in psychological treatment trials relative to pharmacotherapy trials. Cognitive behavioural therapy (CBTI) is the first line treatment for insomnia but studies have reported potential negative effects during acute implementation. This review aimed to understand the extent to which adverse events are monitored for and reported in the CBTI trial literature. Ninety-nine randomised controlled trials were identified for inclusion, with findings showing that 32.3% (n = 32) of studies addressed adverse events in some way, while only 7.1% (n = 7) of studies met all criteria for adequate reporting of adverse events. For studies that reported on adverse events by group, there did not appear to be consistent differences between trial arms, however the limited evidence-base coupled with marked heterogeneity in monitoring and reporting makes it difficult to draw clear conclusions at this time. We outline recommendations for the field aimed at improving prospective monitoring and reporting of adverse events in psychological/behavioural treatment trials.
Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. [2022]Scalable delivery models of cognitive behavioral therapy for insomnia (CBT-I), an effective treatment, are needed for widespread implementation, particularly in rural and underserved populations lacking ready access to insomnia treatment.
Impact of lifestyle modifications on snoring and mild sleep apnoea patients. [2021]Behavioural modification through increasing nutritional awareness, along with customised dietary changes and education about physical inactivity, for obese snorers and mildly sleep apnoeic patients would help improve their quality of life.
Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. [2023]The question that guided this review is whether exercise can add to the improvements in insomnia in patients treated with cognitive behavioral therapy for insomnia (CBT-I). CBT-I has long been recommended as the first-line treatment of chronic insomnia. However, CBT-I is not effective for as many as 30% to 40% of patients with insomnia. There is accumulating evidence for positive effects on insomnia following acute and chronic exercise. However, to the best of our knowledge, the effects of CBT-I combined with exercise have not been explored in clinical trials. In this article, we develop a rationale for combining CBT-I with exercise.