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?

Overweight/obesity and inadequate sleep are prevalent, and frequently co-occurring, health risks among children, both of which are associated with serious medical and psychosocial health complications including risk for cardiovascular disease. Although the investigator's data suggest that disrupted or shortened sleep may be causally associated with increased energy intake and weight gain in children, and with self-regulation and neural response to food cues in adults, understanding of mechanisms involved in the sleep/eating association is incomplete, thereby impeding development of targeted, optimally timed intervention strategies. The proposed mechanistic clinical trial aims to assess the effects of an experimental sleep manipulation on eating-related self-regulation and its neural substrates, and on real-world eating behavior, among children with overweight/obesity, which will help guide research efforts towards the refinement of prevention and intervention strategies targeting sleep and its eating-related correlates to curb weight gain throughout development.

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 safety data exists for sleep management in childhood obesity treatment?

The research does not directly address safety data for sleep management treatments like sleep extension or restriction in childhood obesity. However, studies suggest that sleep interventions can positively impact weight management and reduce obesity risk in children, indicating potential benefits without highlighting specific safety concerns. ^{1 2 3 4 5}

Is sleep extension a promising treatment for managing childhood obesity?

Yes, sleep extension is a promising treatment for managing childhood obesity. Research shows that getting more sleep can help with weight loss and reduce the risk of becoming overweight. Extending sleep duration can improve the effects of a healthy diet and may help prevent obesity in children. ^{1 2 4 6 7}

What data supports the idea that Sleep Management for Childhood Obesity is an effective treatment?

The available research shows that extending sleep duration can help with weight loss in adolescents with 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. Another study showed that longer sleep each week was linked to a greater reduction in body mass index (BMI) over three months in obese adolescents. These findings suggest that sleep management can be an effective part of treating childhood obesity. ^{1 3 7 8 9}

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]

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]

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]

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 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]

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]

Citations

1. United States 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. [2022]

2. Switzerland 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. [2021]

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

Sleep cyclic alternating pattern in otherwise healthy overweight school-age children. [2021]

5. Norway pubmed.ncbi.nlm.nih.gov

Sleep disorders in obese children are not limited to obstructive sleep apnoea syndrome. [2019]

6. England 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. [2022]

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

Sleep Extension: A Potential Target for Obesity Treatment. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The scope of sleep problems in Canadian children and adolescents with obesity. [2019]

9. United States 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. [2022]