ClinicalTrials.gg
CompletedNCT04057716Updated Sep 2, 2026

Project REST: Regulation of Eating and Sleep Topography

An interventional study of Sleep restriction and Sleep extension in Obesity, Childhood, Binge Eating and Sleep, sponsored by University of Pittsburgh. Completed at 2 sites in United States. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Obesity, Childhood
  • Binge Eating
  • Sleep
  • Self-regulation
03

In context

Pediatric Obesity

1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.

Browse Pediatric Obesity studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at risk for obesity (>=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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Sleep restriction followed by extension

    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.

    Behavioral: Sleep restriction · Behavioral: Sleep extension

  • Experimental
    Sleep extension followed by restriction

    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.

    Behavioral: Sleep restriction · Behavioral: Sleep extension

Interventions

  • BehavioralSleep restriction

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

    Also known as: Shortened sleep

  • BehavioralSleep extension

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

    Also known as: Extended sleep

06

What researchers measure

Primary outcomes

  1. Change in Weight Status

    BMI (body mass index)

    Time frame: 4 weeks

  2. Change in Eating Behavior

    measured by 24-hour dietary recall

    Time frame: 4 weeks

  3. Change in Eating Behavior

    measured by ecological momentary assessment

    Time frame: 4 weeks

  4. Self-Regulatory Control

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

    Time frame: 4 weeks

Secondary outcomes

  1. Sleep Patterns

    as measured by actigraph data

    Time frame: 2 weeks

07

Study locations

2 sites
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15213, United States
  • Weight Control & Diabetes Research Center
    Providence, Rhode Island 02903, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2019 to primary completion in Apr 2026, 80 months.

Of 539 non-industry interventional studies with no phase under Pediatric Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 80 months is above that.

Counting every sponsor, half of 541 studies reached it within 25 months; a quarter within 11 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2019
First posted
Aug 15, 2019
StartActual
Aug 15, 2019
Primary completionActual
Apr 30, 2026
CompletionActual
Apr 30, 2026
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04057716
Responsible party
Andrea Goldschmidt (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Aug 15, 2019
Start date
Aug 15, 2019
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026
Last update
Sep 2, 2026

Study contacts

Andrea B Goldschmidt, Ph.D.
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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