RECRUITING

Project REST: Regulation of Eating and Sleep Topography

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-08-15
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04057716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * overweight/obese
  2. * willing to undergo a 30-minute MRI scan
  1. * average sleep time exceeds 10 hours/night
  2. * previous eating disorder diagnosis and/or sleep or psychiatric conditions
  3. * conditions affecting executive functioning (e.g., recent concussion, traumatic brain injury)
  4. * taking medication known to affect sleep/appetite (e.g., antihistamines, stimulants)
  5. * receiving concurrent treatment for sleep or overweight/obesity

Contacts and Locations

Study Contact

Erin Stalvey, B.S.
CONTACT
412-586-9066
stalveyer@upmc.edu
Victoria Bell, B.A.
CONTACT
412-586-9081
bitelab@upmc.edu

Principal Investigator

Andrea B Goldschmidt, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • Andrea B Goldschmidt, Ph.D., PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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

Study Start Date2019-08-15
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2019-08-15
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

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