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Obesity, ChildhoodNCT04057716

Project REST: Regulation of Eating and Sleep Topography

A study testing Sleep restriction and Sleep extension in people with Obesity, Childhood and Binge Eating, run by University of Pittsburgh at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Childhood, Binge Eating, Sleep
What is being tested?
Sleep restriction and Sleep extension
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
2 sitesUnited States
Study dates
15 Aug 2019to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • at risk for obesity (BMI>=85th percentile for age and sex OR BMI>=50th percentile for age and sex with at least one obese parent)
  • average time in bed between 9.5-10.5 hours/night

Who cannot join

  • previous eating disorder diagnosis and/or sleep or psychiatric conditions
  • conditions affecting executive functioning (e.g., recent concussion, traumatic brain injury)
  • taking medication known to affect sleep/appetite (e.g., antihistamines, stimulants)
  • receiving concurrent treatment for sleep or overweight/obesity

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Weight Control & Diabetes Research Center

    Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: Eating-related Self-regulation and Its Neural Substrates as Mechanisms Underlying the Sleep/Eating Behavior Association in Children With Overweight/Obesity: An Ecological Momentary Assessment Study

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.

Read the detailed description

Insufficient sleep and excess weight status contribute to adverse health outcomes across the lifespan, including risk for cardiometabolic disease. Cross-sectional data suggest that children with overweight/obesity are more likely to experience sleep disturbances than their non-overweight peers. Although the nature of this association may be bidirectional, prospective studies indicate that sleep impacts body weight regulation through multiple physiological and psychological pathways. In particular, insufficient sleep is related to greater energy intake and reduced diet quality in children. Although mechanisms explaining the association between sleep and eating behavior are poorly understood, sleep restriction has been found to impact brain processes related to reward valuation of food and self-regulation, the behavioral manifestations of which may increase susceptibility to suboptimal dietary behaviors and subsequent weight gain. A limitation of prior research on mechanisms is that much of it has been conducted in adults and in laboratory settings, thereby calling into question the ecological validity of the findings. Alternatively, studies on sleep restriction/extension in children's natural environments have relied on retrospective reporting of eating behavior, included children across the weight spectrum, and had limited focus on underlying mechanisms, particularly neural substrates. A clearer understanding of momentary mechanisms involved in the sleep/eating association could improve development and/or refinement of sleep-related interventions, particularly those delivered in real time when risk for engaging in maladaptive eating is highest. The proposed R01 study will examine prospective associations among sleep, eating-related self-regulation, and eating behavior in the natural environment. Community-based children with overweight or obesity (n=120) will undergo a naturalistic protocol involving assessment of typical sleep and eating patterns (week 1), followed by sleep restriction or extension (weeks 2 and 3, separated by a 7-day wash-out), the latter occurring within a randomized crossover design. Assessment throughout the study period will involve daily actigraphy measurement of sleep patterns; repeated daily self-reports on eating behavior and behavioral assessment of eating-related self-regulation; and intermittent 24-hour dietary recalls informed by daily real-time food photography. Participants will complete fMRI-based assessment of neural activation during an eating-related self-regulation task after each week-long period of sleep restriction and extension. Overall aims are to assess short-term effects of sleep extension versus restriction on eating-related self-regulation (including behavioral and neural performance) and naturalistic eating behavior. These data will clarify timing and trajectory of changes in eating behavior and self-regulatory mechanisms as a consequence of sleep patterns. The proposed study has clear potential to advance scientific and clinical understanding of mechanisms involved in the prospective associations between inadequate sleep and maladaptive eating in youth and inform interventions to alleviate their cumulative personal and societal burden.

Being tested
Sleep restriction, Sleep extension
Medical subject headings
Pediatric Obesity, Bulimia, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep restrictionBehavioural

    Also called Shortened sleep

    Participants will be asked to restrict their time in bed to 8 hours each night for one week.

  • Sleep extensionBehavioural

    Also called Extended sleep

    Participants will be asked to extend their time in bed to 11 hours each night for one week.

Study groups in NCT04057716
Study groupRoleWhat they receive
Sleep restriction followed by extensionExperimentalChildren 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.
Receives: Behavioral: Sleep restriction; Behavioral: Sleep extension
Sleep extension followed by restrictionExperimentalChildren 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.
Receives: Behavioral: Sleep restriction; Behavioral: Sleep extension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Weight Status

    BMI (body mass index)

    Measured: 4 weeks

  2. Change in Eating Behavior

    measured by 24-hour dietary recall

    Measured: 4 weeks

  3. Change in Eating Behavior

    measured by ecological momentary assessment

    Measured: 4 weeks

  4. Self-Regulatory Control

    as measured by the Go/No-Go task (errors and response latency)

    Measured: 4 weeks

Secondary outcomes (1)
  1. Sleep Patterns

    as measured by actigraph data

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study start15 Aug 2019
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be instructed to restrict or expand their sleep for one week each within a randomized crossover design, separated by a one week wash-out period.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057716
Sponsor's protocol ID
STUDY21070047
Other IDs
R01HL147914
Status last verified
Aug 2026
First submitted
9 Aug 2019
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sleep restriction and Sleep extension in people with Obesity, Childhood and Binge Eating, run by University of Pittsburgh at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Weight Status (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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