Project REST: Regulation of Eating and Sleep Topography

NCT04057716 | Recruiting DMC

• 2 other identifiers: STUDY21070047R01HL147914
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Obesity, Childhood; Binge Eating; Sleep; Self-regulation

Outcome Measures

Primary Outcomes (4)

• Change in Weight Status

  BMI (body mass index)

  4 weeks

• Change in Eating Behavior

  measured by 24-hour dietary recall

  4 weeks

• Change in Eating Behavior

  measured by ecological momentary assessment

  4 weeks

• Self-Regulatory Control

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

  4 weeks

Secondary Outcomes (1)

• Sleep Patterns

  2 weeks

Study Arms (2)

Sleep restriction followed by extension

EXPERIMENTAL

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

Sleep extension followed by restriction

EXPERIMENTAL

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

Sleep restriction BEHAVIORAL

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

Also known as: Shortened sleep

Sleep extension followed by restriction; Sleep restriction followed by extension

Sleep extension BEHAVIORAL

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

Also known as: Extended sleep

Sleep extension followed by restriction; Sleep restriction followed by extension

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Weight Control & Diabetes Research Center

Providence, Rhode Island, 02903, United States

COMPLETED

Related Links

• Lab website with description of current studies (including Project REST)

MeSH Terms

Conditions

Pediatric Obesity; Bulimia; Self-Control

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive; Social Behavior; Behavior

Study Officials

• Andrea B Goldschmidt, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Stalvey, B.S.

CONTACT

412-586-9066; stalveyer@upmc.edu

Victoria Bell, B.A.

CONTACT

412-586-9081; bitelab@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will be blinded to sleep condition in order to obtain unbiased estimates of study outcomes (e.g., weight, eating behavior).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 15, 2019
• Study Start: August 15, 2019
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)