120 Participants Needed

Sleep Management for Childhood Obesity

BB
ES
BH
VB
Overseen ByVictoria Bell, B.A.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.13678

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.14679

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.

Research Team

AB

Andrea B Goldschmidt, Ph.D.

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sleep restriction followed by extensionExperimental Treatment2 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 restrictionExperimental Treatment2 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.

Find a Clinic Near You

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+

Findings from Research

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.
Sleep Extension Increases the Effect of Caloric Restriction Over Body Weight and Improves the Chronic Low-Grade Inflammation in Adolescents With Obesity.Moreno-Frรญas, 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/mยฒ 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.
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.
Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood.Zheng, M., Hesketh, KD., Wu, JHY., et al.[2021]

References

Sleep Extension Increases the Effect of Caloric Restriction Over Body Weight and Improves the Chronic Low-Grade Inflammation in Adolescents With Obesity. [2022]
Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program. [2021]
Nighttime sleep duration trajectories were associated with body mass index trajectories in early childhood. [2021]
Sleep cyclic alternating pattern in otherwise healthy overweight school-age children. [2021]
Sleep disorders in obese children are not limited to obstructive sleep apnoea syndrome. [2019]
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]
Sleep Extension: A Potential Target for Obesity Treatment. [2021]
The scope of sleep problems in Canadian children and adolescents with obesity. [2019]
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]
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