Project REST: Regulation of Eating and Sleep Topography

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Obesity, Childhood; Binge Eating; Self-regulation
• Intervention / Treatment: Behavioral: Sleep restriction; Behavioral: Sleep extension

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Stalvey, B.S.; Phone Number: 412-586-9066; Email: stalveyer@upmc.edu
• Study Contact Backup: Name: Victoria Bell, B.A.; Phone Number: 412-586-9081; Email: bitelab@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • University of Pittsburgh
      • Contact: Erin Stalvey, B.S.; Phone Number: 412-586-9066; Email: stalveyer@upmc.edu
      • Principal Investigator: Andrea B Goldschmidt, Ph.D.
      • Contact: Victoria Bell, B.A.; Phone Number: 412-586-9081; Email: bitelab@upmc.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Completed
      • Weight Control & Diabetes Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Participants will be asked to restrict their time in bed to 8 hours each night for one week.; Other Names: Shortened sleep; Behavioral: Sleep extension; Participants will be asked to extend their time in bed to 11 hours each night for one week.; Other Names: Extended sleep
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; Participants will be asked to restrict their time in bed to 8 hours each night for one week.; Other Names: Shortened sleep; Behavioral: Sleep extension; Participants will be asked to extend their time in bed to 11 hours each night for one week.; Other Names: Extended sleep

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Patterns	as measured by actigraph data	2 weeks

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Andrea B Goldschmidt, Ph.D., University of Pittsburgh

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2019
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (Actual): August 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperphagia; Obesity; Pediatric Obesity; Bulimia
• Other Study ID Numbers: STUDY21070047; R01HL147914 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No