Sleep Management for Childhood Obesity

Overseen By Victoria Bell, B.A.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Antihistamines, Stimulants

Disqualifiers: Eating disorders, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different sleep patterns affect eating habits and self-control in children who are overweight or at risk of becoming overweight. Researchers will test two approaches: one where children sleep less and then more (sleep restriction), and another where they sleep more and then less (sleep extension). The goal is to determine if changing sleep duration can influence how children regulate their eating and respond to food. Eligible children typically sleep around 9.5 to 10.5 hours a night and have a higher BMI or an obese parent. Participants should not have any sleep, eating, or psychiatric disorders or be on medication affecting sleep or appetite. This unphased trial offers a unique opportunity to contribute to understanding the impact of sleep on children's health.

Do I have to stop taking my current medications?

Yes, if you are taking medication known to affect sleep or appetite, you will need to stop taking it to participate in the trial.

What prior data suggests that this sleep management protocol is safe for children with overweight/obesity?

Research shows that this trial explores two main treatments: sleep extension and sleep restriction.

For sleep extension, studies have found that more sleep can help adults with overweight eat less, potentially leading to weight loss. This suggests sleep extension could be a safe method for managing obesity. The research does not report any serious side effects, indicating a positive safety profile.

Conversely, sleep restriction, or getting less sleep, has been linked to a higher risk of obesity, especially in children and teenagers. Evidence shows that less sleep can affect thinking and understanding, particularly in those who are overweight or obese. While no specific reports of negative effects from sleep restriction exist, the potential impact on cognitive function should be considered.

Both treatments are under study to assess their effects on sleep patterns and weight management. The current trial phase means safety information is still being gathered, but existing research suggests that sleep extension is generally safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these sleep management techniques because they offer a non-invasive way to tackle childhood obesity. Unlike traditional treatments like diet adjustments, exercise programs, or medication, these methods focus on altering sleep patterns. The unique approach involves either limiting or extending sleep to see how it impacts weight. By understanding the role of sleep in managing obesity, this trial could pave the way for innovative strategies that are simple, cost-effective, and easy to implement in everyday life.

What evidence suggests that this trial's sleep treatments could be effective for childhood obesity?

This trial will compare the effects of sleep extension and sleep restriction on childhood obesity. Studies have shown that more sleep can help people eat less and lose weight, supporting weight management. Specifically, one study found that combining more sleep with a healthy diet led to greater weight loss and improved health markers related to inflammation. Conversely, research indicates that insufficient sleep can increase children's appetite and reduce their sense of fullness, making it harder to control eating. Both increased and insufficient sleep are closely linked to obesity in children, particularly those in middle school. These findings highlight the potential of managing sleep as a strategy for addressing childhood obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrea B Goldschmidt, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children who are overweight or obese and willing to have an MRI scan. It's not suitable for those with conditions affecting brain function, like a recent concussion, more than 10 hours of sleep per night, past eating disorders, sleep or psychiatric conditions, or if they're on medications that affect sleep or appetite.

Inclusion Criteria

I am overweight or obese.

I am overweight or obese.

I am willing to have a 30-minute MRI scan.

Exclusion Criteria

I am taking medication that can affect my sleep or appetite.

You sleep more than 10 hours per night on average.

I have been diagnosed with an eating, sleep, or psychiatric disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Assessment of typical sleep and eating patterns using actigraphy and self-reports

1 week

Daily assessments

Sleep Manipulation

Participants undergo sleep restriction or extension in a randomized crossover design

2 weeks

Daily assessments, fMRI after each week

Wash-out Period

A 7-day wash-out period between sleep manipulation phases

1 week

Follow-up

Participants are monitored for changes in eating behavior and self-regulatory control

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep extension
• Sleep restriction

Trial Overview Project REST aims to see how changing the amount of sleep can influence children's self-control around eating and their brain activity related to food. The study will test whether more or less sleep affects real-world eating behavior in kids with weight issues.

How Is the Trial Designed?

Group I: Sleep restriction followed by extension Experimental Treatment 2 Interventions

Children will spend 8 hours in bed for one week, engage in one week of wash-out, and then spend 11 hours in bed for one week.

Group II: Sleep extension followed by restriction Experimental Treatment 2 Interventions

Children will spend 11 hours in bed for one week, engage in one week of wash-out, and then spend 8 hours in bed for one week.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 52 adolescents with obesity, those who extended their sleep while following a 500-calorie restricted diet experienced significantly greater weight loss and waist girth reduction compared to those who did not extend their sleep.

Sleep extension also led to improvements in metabolic markers, including reduced insulin and interleukin 6 levels, suggesting that better sleep may enhance the effectiveness of dietary interventions for obesity in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Extension Increases the Effect of Caloric Restriction Over Body Weight and Improves the Chronic Low-Grade Inflammation in Adolescents With Obesity. Moreno-Frías, C., Figueroa-Vega, N., Malacara, JM.[2022]

In a study of 83 obese adolescents, those who reported getting more sleep during the week were more likely to experience a reduction in BMI after 3 months in a weight management program.

Adolescents who lost at least 1 kg/m² in BMI reported an average of 60.7 hours of sleep per week, compared to 56.4 hours for those with less weight loss, suggesting that improving sleep duration could be beneficial for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program. Sallinen, BJ., Hassan, F., Olszewski, A., et al.[2021]

In a study of 528 infants followed from 4 to 60 months, longer nighttime sleep duration was linked to lower BMI z-scores, suggesting that adequate nighttime sleep may help prevent obesity in early childhood.

The research found that only nighttime sleep duration, not total or daytime sleep, was associated with healthier weight trajectories, highlighting the critical role of nighttime sleep in childhood development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. Zheng, M., Hesketh, KD., Wu, JHY., et al.[2021]

In a study of 58 healthy 10-year-old children, those who were overweight exhibited distinct differences in sleep microstructure, particularly during slow-wave sleep, compared to their normal-weight peers.

Overweight children showed a higher rate of cyclic alternating patterns (CAP) but shorter durations of certain sleep phases, suggesting that their slow-wave sleep may be less stable, which could impact overall sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep cyclic alternating pattern in otherwise healthy overweight school-age children. Chamorro, R., Ferri, R., Algarín, C., et al.[2021]

Sleep extension has the potential to improve health outcomes related to obesity, such as glycemic control and blood pressure, based on preliminary findings from studies on habitually short sleepers.

While there are challenges in implementing sleep extension interventions, they may help mitigate the health risks associated with short sleep and obesity, indicating a need for further research to optimize these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Extension: A Potential Target for Obesity Treatment. Hoddy, KK., Potts, KS., Bazzano, LA., et al.[2021]

In a study of 128 obese children aged around 12 years, a sleep specialist confirmed that 98.4% had sleep disorders, including respiratory issues like obstructive sleep apnoea syndrome (OSAS) in 24.2% of cases.

The findings highlight the importance of specialized sleep consultations for diagnosing and managing a range of sleep disorders in obese children, which can aid in their overall treatment and management of obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disorders in obese children are not limited to obstructive sleep apnoea syndrome. Carriere, C., Coste, O., Meiffred-Drouet, MC., et al.[2019]

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]

Short sleep duration in preschool children is significantly associated with a higher risk of developing obesity, with a relative risk of 1.54 based on a review of 13 studies involving 42,878 participants.

Interventions aimed at improving sleep in preschool children have shown promising results, with four out of five studies reporting reductions in BMI and BMI z-scores, indicating that better sleep may help reduce weight gain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analyses of the relationship between short sleep and incidence of obesity and effectiveness of sleep interventions on weight gain in preschool children. Miller, MA., Bates, S., Ji, C., et al.[2022]

In a study of 205 children aged 8-16 years with obesity, 44% were found to have obstructive sleep apnea (OSA) based on polysomnography (PSG) results, highlighting the prevalence of this condition in this population.

Factors such as mouth breathing, a family history of OSA, and the presence of syndromes or multiple anomalies were identified as significant predictors of OSA, suggesting that early identification and treatment of sleep issues could improve health outcomes for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The scope of sleep problems in Canadian children and adolescents with obesity. MacLean, JE., DeHaan, K., Chowdhury, T., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8140617/

Sleep Extension: A potential target for obesity treatment A longer study lasting 4 weeks only averaged 21 minutes of sleep extension and less than 10% of the cohort reached 7 hours of nightly sleep with a target TIB ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079221001179

Behavioral interventions to extend sleep duration The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12.

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2788694

Effect of Sleep Extension on Objectively Assessed Energy ... Conclusions and Relevance This trial found that sleep extension reduced energy intake and resulted in a negative energy balance in real-life ...

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

Optimizing intervention components for sleep promotion in ... Insufficient sleep duration is highly prevalent in childhood and is associated with obesity, especially among middle school children.

5. withpower.com withpower.com/trial/phase-obesity-7-2019-66c46

Sleep Management for Childhood Obesity One study found that when sleep extension was combined with a diet, it increased weight loss and improved inflammation, which is a sign of better health.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352721823002334

Predictors for achieving optimal sleep in healthy children Seventy-four (74.8%) participants had sleep periods less than this at baseline, of which 30 (40.5%) successfully extended their sleep. Overall, 33 (33.3%) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11347100/

Adverse Childhood Experiences May Dampen the Protective ... Increasing sleep duration is a recognized intervention target to decrease obesity risk, yet in adolescents experiencing ≥ 1 ACE, this protective ...

8. journals.lww.com journals.lww.com/jehp/fulltext/2025/01310/association_of_sleep_duration_with_overweight_and.43.aspx

Association of sleep duration with overweight and obesity... This study investigates the association between sleeping behaviors and overweight/obesity among Pakistani school-aged children and adolescents (9–17 years).