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Project REST: Regulation of Eating and Sleep Topography

Primary Purpose

Obesity, Childhood, Binge Eating, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep restriction
Sleep extension
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity, Childhood

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • overweight/obese
  • right-handed
  • 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)
  • braces/metal in body
  • taking medication known to affect sleep/appetite (e.g., antihistamines, stimulants)
  • receiving concurrent treatment for sleep or overweight/obesity

Sites / Locations

  • University of PittsburghRecruiting
  • Weight Control & Diabetes Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep restriction followed by extension

Sleep extension followed by restriction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Weight Status
BMI (body mass index)
Change in Eating Behavior
measured by 24-hour dietary recall
Change in Eating Behavior
measured by ecological momentary assessment
Self-Regulatory Control
as measured by the Go/No-Go task (errors and response latency)

Secondary Outcome Measures

Sleep Patterns
as measured by actigraph data

Full Information

First Posted
August 9, 2019
Last Updated
February 3, 2023
Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04057716
Brief Title
Project REST: Regulation of Eating and Sleep Topography
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Binge Eating, Sleep, Self-regulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The assessor will be blinded to sleep condition in order to obtain unbiased estimates of study outcomes (e.g., weight, eating behavior).
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep restriction followed by extension
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep extension followed by restriction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep restriction
Other Intervention Name(s)
Shortened sleep
Intervention Description
Participants will be asked to restrict their time in bed to 8 hours each night for one week.
Intervention Type
Behavioral
Intervention Name(s)
Sleep extension
Other Intervention Name(s)
Extended sleep
Intervention Description
Participants will be asked to extend their time in bed to 11 hours each night for one week.
Primary Outcome Measure Information:
Title
Change in Weight Status
Description
BMI (body mass index)
Time Frame
4 weeks
Title
Change in Eating Behavior
Description
measured by 24-hour dietary recall
Time Frame
4 weeks
Title
Change in Eating Behavior
Description
measured by ecological momentary assessment
Time Frame
4 weeks
Title
Self-Regulatory Control
Description
as measured by the Go/No-Go task (errors and response latency)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sleep Patterns
Description
as measured by actigraph data
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blair Harvie
Phone
412-586-9081
Email
bitelab@upmc.edu
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Harvie
Phone
412-586-9081
Email
bitelab@upmc.edu
First Name & Middle Initial & Last Name & Degree
Andrea B Goldschmidt, Ph.D.
Facility Name
Weight Control & Diabetes Research Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://weightresearch.org/currentstudies.html
Description
Related Info

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Project REST: Regulation of Eating and Sleep Topography

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