Sleep & Exercise Intervention for Obesity

Recruiting at 1 trial location

Overseen By Lorna McNeill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Sleep disorders, Psychiatric disorders, Thyroid conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

28 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 6 7 8 9}

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. ^{5 6 7 10 11}

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. ^{5 6 7 10 11}

Who Is on the Research Team?

Lorna McNeill

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

You usually sleep less than or equal to 6 hours per night.

Access to internet

My BMI is 25 or higher, indicating I am overweight or obese.

Exclusion Criteria

I work night shifts or travel across time zones for work weekly.

Participated in formative focus groups/individual interviews for this study

Blood pressure readings >= 140/90 mm or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading >= 140/90 mm Hg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Groups and Interviews

Participants attend either a focus group or interview about the sleep intervention and sleep-related problems

1 week

1 visit (in-person or virtual)

Intervention

Participants receive a web-based sleep intervention and health coaching sessions, or educational material and counseling sessions

9 weeks

Weekly web-based sessions

Follow-up

Participants are monitored for changes in sleep, physical activity, and sedentary behavior

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep and Physical Activity Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Group II (health coaching session, sleep intervention) Experimental Treatment 3 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 Treatment 3 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 Treatment 3 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 Control 4 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a 12-week trial involving 49 overweight or obese adults, those who received a combined weight management and sleep intervention (better weight-better sleep) lost weight faster compared to those who only received weight management support.

Participants in the combined intervention group also showed improved coping self-efficacy, suggesting that integrating sleep management with dietary and exercise interventions may enhance overall effectiveness in obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. Logue, EE., Bourguet, CC., Palmieri, PA., et al.[2018]

A six-month aerobic exercise program significantly improved sleep quality in overweight and obese men with chronic insomnia, reducing the time it took to fall asleep and the frequency of sleep initiation difficulties.

Participants in the exercise group experienced better overall sleep metrics, including shorter wake times after sleep onset and improved sleep efficiency, compared to their baseline measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on home-based sleep among overweight and obese men with chronic insomnia symptoms: a randomized controlled trial. Tan, X., Alén, M., Wiklund, P., et al.[2022]

In a study of 71 outpatients with chronic insomnia, combining physical activity counseling with sleep restriction therapy (PASR) significantly increased physical activity levels and daily steps compared to sleep restriction alone.

Patients in the PASR group also experienced better improvements in sleep quality, as measured by the Epworth Sleepiness Scale and Fatigue Scale-14, indicating that this combined approach is effective for enhancing both physical activity and sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of physical activity counseling plus sleep restriction therapy on the patients with chronic insomnia. Wang, J., Yin, G., Li, G., et al.[2020]

In a study of 114 overweight or obese adults undergoing a 12-month behavioral weight loss intervention, those who lost at least 5% of their body weight experienced a significant reduction in obstructive sleep apnea (OSA) severity, as measured by the apnea-hypopnea index (AHI).

Conversely, individuals with OSA lost less weight and showed lower adherence to calorie goals and physical activity compared to those without OSA, indicating that OSA may hinder effective weight loss efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bidirectional Relationships Between Weight Change and Sleep Apnea in a Behavioral Weight Loss Intervention. Kline, CE., Burke, LE., Sereika, SM., et al.[2023]

A tailored behavioral sleep medicine (BSM) intervention combined with CPAP treatment led to significant long-term improvements in obstructive sleep apnea (OSA) severity, with 36.7% of participants in the experimental group experiencing a better OSA category compared to only 6.7% in the control group after 18 months.

Participants receiving the BSM intervention showed a greater reduction in the apnea-hypopnea index (AHI) compared to those on CPAP alone, highlighting the effectiveness of addressing physical activity and eating behaviors alongside traditional CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Spörndly-Nees, S., Åsenlöf, P., Lindberg, E., et al.[2021]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for many, but 30% to 40% of patients do not respond, highlighting a need for additional treatment options.

This review suggests that combining CBT-I with exercise could enhance insomnia treatment outcomes, as both interventions have shown positive effects on sleep, although clinical trials on their combined effects are currently lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. Passos, GS., Youngstedt, SD., Santana, MG.[2023]

A study involving older veterans with insomnia found that baseline self-reported physical activity levels did not significantly affect the efficacy of cognitive behavioral therapy for insomnia (CBT-I).

Both low and high physical activity groups showed similar improvements in sleep outcomes after receiving CBT-I, indicating that even those with low physical activity can benefit from this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Outcomes With Cognitive Behavioral Therapy for Insomnia Are Similar Between Older Adults With Low vs. High Self-Reported Physical Activity. Yeung, T., Martin, JL., Fung, CH., et al.[2020]

In a review of 99 randomized controlled trials on cognitive behavioral therapy for insomnia (CBTI), only 32.3% addressed adverse events, highlighting a significant gap in monitoring during psychological treatment compared to pharmacotherapy.

Only 7.1% of the studies met all criteria for adequate reporting of adverse events, indicating a need for improved standards in documenting potential negative effects of CBTI to ensure patient safety and treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. Condon, HE., Maurer, LF., Kyle, SD.[2021]

Telephone-based cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep quality in older adults with insomnia and osteoarthritis pain, with a mean reduction of 8.1 points on the Insomnia Severity Index (ISI) compared to 4.8 points in the education-only control group after 2 months.

The benefits of CBT-I were sustained at a 12-month follow-up, with 56.3% of participants in the CBT-I group remaining in remission, highlighting its effectiveness as a scalable treatment option for insomnia in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. McCurry, SM., Zhu, W., Von Korff, M., et al.[2022]

In a study involving 16 adolescent girls with obesity, a single session of intense exercise significantly improved sleep duration and quality compared to a control session, indicating that exercise can be an effective nonpharmacological treatment for sleep issues.

Following the exercise, participants showed a decrease in caloric intake and consumption of energy-dense foods, suggesting that acute exercise may help regulate dietary choices in adolescents with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute intense exercise improves sleep and decreases next morning consumption of energy-dense food in adolescent girls with obesity and evening chronotype. Saidi, O., Rochette, E., Bovet, M., et al.[2020]

A one-year study involving 72 patients (36 in the test group and 36 in the control group) demonstrated that increasing nutritional awareness and providing customized dietary changes significantly improved snoring severity and daytime sleepiness in obese snorers and mildly sleep apnoeic patients.

The test group showed highly significant improvements in quality of life measures after 6 and 12 months, while the control group did not show any significant changes, highlighting the effectiveness of dietary intervention in managing sleep-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of lifestyle modifications on snoring and mild sleep apnoea patients. Sahni, N., Arora, K., Bansal, S., et al.[2021]

Citations

1. England pubmed.ncbi.nlm.nih.gov

The better weight-better sleep study: a pilot intervention in primary care. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise on home-based sleep among overweight and obese men with chronic insomnia symptoms: a randomized controlled trial. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy of physical activity counseling plus sleep restriction therapy on the patients with chronic insomnia. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Bidirectional Relationships Between Weight Change and Sleep Apnea in a Behavioral Weight Loss Intervention. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Outcomes With Cognitive Behavioral Therapy for Insomnia Are Similar Between Older Adults With Low vs. High Self-Reported Physical Activity. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in cognitive behavioural therapy for insomnia: A systematic examination of randomised controlled trials. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Acute intense exercise improves sleep and decreases next morning consumption of energy-dense food in adolescent girls with obesity and evening chronotype. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Impact of lifestyle modifications on snoring and mild sleep apnoea patients. [2021]