Project REST: Regulation of Eating and Sleep Topography
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
🗓️ Study Start (Actual) 15 August 2019
🗓️ Primary Completion (Estimated) 31 May 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Pittsburgh, Pennsylvania, United States
📍 Providence, Rhode Island, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * overweight/obese
    • * willing to undergo a 30-minute MRI scan

    Exclusion Criteria:

    • * average sleep time exceeds 10 hours/night
    • * 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
Ages Eligible for Study: 8 Years to 12 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 August 2019
  • First Submitted that Met QC Criteria 13 August 2019
  • First Posted 15 August 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 June 2024
  • Last Update Posted 10 June 2024
  • Last Verified June 2024