Sleep Intervention for Obesity

Overseen By Ivan Wu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Minnesota

Disqualifiers: Organ disorders, Pregnancy, Infant care, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a sleep intervention (also known as Sleep Therapy, Sleep Education Program, or Behavioral Sleep Intervention) to improve sleep duration and quality among African American adults with obesity or who are overweight. The goal is to determine if better sleep can reduce the risk of health issues like cancer and obesity-related problems. Participants will aim to increase their sleep by an hour over four weeks, with support from a counselor. Suitable candidates for this trial are those who self-identify as Black or African American, sleep 6 hours or less per night, and struggle to meet physical activity guidelines. As an Early Phase 1 trial, this study focuses on understanding how the sleep intervention works in people, offering participants the chance to be among the first to explore its potential benefits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that sleep programs designed to improve sleep duration and quality are usually safe and manageable. Studies have explored methods to enhance sleep for both children and adults, demonstrating that these approaches can be implemented without major issues. One study found that a sleep program helped children sleep longer without significant problems. Another study emphasized the importance of incorporating sleep improvement into family programs, which also proved safe.

Specific information about side effects for the sleep program in this trial is limited, but its early testing phase suggests initial evidence of safety. Early trials primarily assess safety, so treatments with major safety concerns would not progress. Additionally, sleep programs often involve changes like improved sleep habits, which typically pose very low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard obesity treatments that often focus on diet and exercise, the sleep intervention aims to tackle obesity by increasing sleep duration. Researchers are excited about this approach because it highlights the importance of sleep in weight management, a factor often overlooked in traditional treatments. This intervention is unique because it provides personalized weekly support and education on sleep hygiene, which could lead to sustainable lifestyle changes and improved overall health.

What evidence suggests that this sleep intervention could be effective for obesity?

Research shows that improving sleep can help manage being overweight or obese. A review of studies found that better sleep can lead to weight loss and improved sleep quality and duration. Another study found that children who sleep longer are less likely to become overweight. While most research focuses on children, these findings suggest that better sleep can also help adults with obesity. In this trial, participants will join either a sleep intervention group, which aims to increase total sleep time, or a contact control group. By sleeping more, the body may better control weight and overall health. ^{1 3 6 7 8}

Who Is on the Research Team?

Ivan Wu

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for African American adults aged 21-65 with a BMI of 25.0 to 40 kg/m2 who aren't very active, sleep ≤6 hours on average, and are not meeting physical activity guidelines. It's not for those with certain organ disorders, pregnant or recent mothers, or those with infants under one year old in the household.

Inclusion Criteria

You do not meet the recommended level of physical activity.

Your body mass index (BMI) is between 25.0 and 40.

I am between 21 and 65 years old.

Exclusion Criteria

Pregnant or less than 4 months postpartum

I have an infant under 1 year old living in my house.

I have a condition like COPD, heart rhythm problems, or stomach issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week sleep extension intervention with weekly one-on-one contact to increase total sleep time by 60 minutes

4 weeks

4 visits (virtual)

Follow-up

Participants are monitored for satisfaction and adherence post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Contact Control
• Sleep intervention

Trial Overview The study aims to adapt a sleep intervention for African American adults who are overweight/obese and don't get enough sleep or exercise. The goal is to improve their health by reducing risks related to cancer and obesity through better sleep habits.

How Is the Trial Designed?

Group I: Sleep intervention Experimental Treatment 1 Intervention

The sleep extension intervention is a 4-week intervention consisting of weekly one-on-one contact with the goal of increasing total sleep time by 60 minutes by the end of four weeks conducted by Dr. Wu or a trained counselor. The first session will last 60 minutes and the content will include psychoeducation about the importance of sleep, sleep guidelines and target setting, and basic sleep hygiene. Participants in this condition will receive hardcopy weekly daily diary worksheets, and receive an online version of the sleep daily diary every morning to complete via text messaging. Sessions 2-4 will be between 15-30 minutes where Dr. Wu or a trained counselor will review the sleep diary, problem solve barriers to weekly goals, and sleep promoting behaviors will be reinforced. Material that would be covered during a missed session will be included in the next session the participant attends.

Group II: Contact control Active Control 1 Intervention

The content of the contacts for this intervention condition will be based on the National Center for Healthy Housing's Healthy Homes program, a program designed by the UT School of Public Health. Participants in this condition will meet with Dr. Wu or a trained research staff member. They will meet through Zoom once a week for four sessions to go through each educational module. Sessions will conclude with the development of an action plan for participants. Staff will check in with participants regarding whether they were able to complete the tasks on their action plan, and if not, the reasons for this and potential strategies that may facilitate completion.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

There is a growing concern about how inadequate sleep and sleep disorders contribute to obesity, with evidence suggesting that both sex and environmental factors play significant roles in this relationship.

Research indicates that men and women may respond differently to sleep disruption, which could influence weight gain, highlighting the need for targeted therapies that consider these sex disparities and the impact of the obesogenic environment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Sex and the Environment in Moderating Weight Gain Due to Inadequate Sleep. Coborn, JE., Houser, MM., Perez-Leighton, CE., et al.[2019]

Establishing consistent bedtime routines and creating a conducive sleep environment are effective strategies for improving sleep in children, which may help prevent obesity.

Health care professionals can play a crucial role in educating parents about sleep strategies early in a child's life, potentially reducing the risk of obesity and its associated long-term health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review of sleep interventions and related clinical implications for obesity treatment in children. Fenton, K., Marvicsin, D., Danford, CA.[2016]

A behavioral sleep intervention, based on cognitive behavioral therapy for insomnia (CBT-I), was effective in reducing insomnia symptoms among pregnant women, with significant improvements noted in the third trimester and postpartum periods.

Women in the intervention group experienced lower rates of moderate to severe insomnia and reduced insomnia severity scores compared to the control group, indicating that this approach can be beneficial for managing sleep issues during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Sleep Intervention Delivered through Group Prenatal Care to Overweight and Obese Women. Cain, MA., Brumley, J., Louis-Jacques, A., et al.[2020]

This umbrella review analyzed 35 systematic reviews and meta-analyses to evaluate non-pharmacological sleep health interventions in primarily healthy populations, highlighting effective strategies such as later school start times, behavior change methods, and mind-body exercises.

While some interventions like sleep education and relaxation techniques showed potential benefits for sleep quality, the evidence was less consistent, indicating a need for further research to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. Albakri, U., Drotos, E., Meertens, R.[2021]

In a study of 150 participants over 12 months, better sleep quality and fewer awakenings were linked to higher self-efficacy in adhering to a weight loss plan, suggesting that sleep plays a crucial role in weight loss success.

Participants averaged about 7 hours of sleep per night, and improvements in sleep dimensions were consistently associated with increased confidence in following their daily lifestyle recommendations, highlighting the importance of sleep in weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nightly Variation in Sleep Influences Self-efficacy for Adhering to a Healthy Lifestyle: A Prospective Study. Burke, LE., Kline, CE., Mendez, DD., et al.[2023]

A 2-year weight reduction program for 33 obese patients with obstructive sleep apnea syndrome (OSAS) led to significant improvements in oxygen desaturation index (ODI), arousal index, and body mass index, indicating better respiratory function and reduced daytime sleepiness.

While the program had limited success in significantly reducing the apnea-hypopnea index (AHI), it still showed positive effects on quality of life and metabolic status, suggesting it can be a helpful adjunct treatment for motivated patients with OSAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-year weight reduction program in obese sleep apnea patients. Nerfeldt, P., Nilsson, BY., Mayor, L., et al.[2021]

Insufficient sleep in infancy and early childhood is linked to an increased risk of overweight and obesity, highlighting the importance of sleep duration in childhood health.

Interventions designed to improve sleep quality and quantity may be effective strategies for preventing childhood obesity, although more research is needed to fully understand the mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. Ash, T., Taveras, EM.[2022]

The sleep intervention in infancy significantly reduced BMI z scores at ages 3.5 and 5 years, suggesting it is effective in preventing obesity compared to usual care.

In contrast, the nutrition and activity intervention (FAB group) unexpectedly led to higher BMI z scores at age 5 years, indicating potential adverse effects of this conventional approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, nutrition, and physical activity interventions to prevent obesity in infancy: follow-up of the Prevention of Overweight in Infancy (POI) randomized controlled trial at ages 3.5 and 5 y. Taylor, RW., Gray, AR., Heath, AM., et al.[2023]

Poor sleep disrupts hormones related to the food reward system, making it harder for individuals to lose weight and maintain weight-loss programs.

Conversely, obesity can lead to sleep disturbances, creating a cycle that complicates both weight management and sleep quality; exploring effective treatments is crucial for breaking this cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadequate sleep & obesity: Breaking the vicious cycle. Jaqua, EE., Mapar, A., Tran, MN., et al.[2023]

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]

Obstructive sleep apnoea (OSA) is often linked with obesity, affecting about 70% of patients, and while CPAP therapy is the standard treatment, it does not lead to significant long-term weight loss or improvements in cardiovascular health.

The study proposes that Erikson coaching, a lifestyle intervention, could enhance adherence to healthy behaviors in obese OSA patients, potentially leading to weight reduction and better metabolic health, which may ultimately reduce cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erickson health coaching: An innovative approach for weight management in obese patients with obstructive sleep apnoea? Tkacova, R.[2019]

Insufficient sleep and irregular sleep patterns are linked to obesity and unhealthy eating behaviors, but the exact mechanisms are still unclear due to inconsistencies in existing research.

There is a need for more studies to explore how addressing sleep disturbances could enhance weight loss treatments, considering factors like sleep duration and sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep, obesity, and weight loss in adults: is there a rationale for providing sleep interventions in the treatment of obesity? Coughlin, JW., Smith, MT.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4893806/

Development of a Behavioral Sleep Intervention as a Novel ... Children with a shorter sleep duration had twice the risk of overweight/obesity (odds ratio 2.15; 95% CI: 1.64–2.81) compared to their longer sleeping peers.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06810557

Brief Behavioral Sleep Intervention for Obesity Prevention ... The present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10825984/

a systematic review and meta-analysis - PMC - PubMed Central This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity ...

4. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2023.1264532/full

Optimizing intervention components for sleep promotion in ... This paper presents the protocol for a randomized optimization trial using the Multiphase Optimization Strategy (MOST) to develop a mobile health platform.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-17708-6

a systematic review and meta-analysis | BMC Public Health This systematic review examines the efficacy of sleep interventions alone or as a part of lifestyle interventions for the management of overweight or obesity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6422003/

Inclusion of Sleep Promotion in Family-Based Interventions To ... This study examines the proportion and context of family-based interventions to prevent childhood obesity that promote child sleep.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-10565

Cognitive Behavioral Therapy for Insomnia Compared to ... CBT-I plus BWL may be more effective than EDU plus BWL in improving sleep, weight loss and body composition in overweight or obese women with breast DCIS or ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794639

Effects of a Sleep Health Education Program for Children ... The primary outcome, nighttime sleep duration, increased to clinically insignificant means of 5.6 minutes at 9 months (primary outcome) and 6.8 ...