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Project REST: Regulation of Eating and Sleep Topography

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ClinicalTrials.gov Identifier: NCT04057716
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : January 31, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Andrea Goldschmidt, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity, Childhood Binge Eating Sleep Self-regulation Behavioral: Sleep restriction Behavioral: Sleep extension Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (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).
Primary Purpose: Basic Science
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
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : July 31, 2024

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 Name: Shortened sleep

Behavioral: Sleep extension
Participants will be asked to extend their time in bed to 11 hours each night for one week.
Other Name: 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 Name: Shortened sleep

Behavioral: Sleep extension
Participants will be asked to extend their time in bed to 11 hours each night for one week.
Other Name: Extended sleep




Primary Outcome Measures :
  1. Change in Weight Status [ Time Frame: 4 weeks ]
    BMI (body mass index)

  2. Change in Eating Behavior [ Time Frame: 4 weeks ]
    measured by 24-hour dietary recall

  3. Change in Eating Behavior [ Time Frame: 4 weeks ]
    measured by ecological momentary assessment

  4. Self-Regulatory Control [ Time Frame: 4 weeks ]
    as measured by the Go/No-Go task (errors and response latency)


Secondary Outcome Measures :
  1. Sleep Patterns [ Time Frame: 2 weeks ]
    as measured by actigraph data



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04057716


Contacts
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Contact: Blair Harvie 412-586-9081 bitelab@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Blair Harvie    412-586-9081    bitelab@upmc.edu   
Principal Investigator: Andrea B Goldschmidt, Ph.D.         
United States, Rhode Island
Weight Control & Diabetes Research Center Completed
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
  Study Documents (Full-Text)

Documents provided by Andrea Goldschmidt, University of Pittsburgh:
Informed Consent Form  [PDF] January 11, 2022

Additional Information:
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Responsible Party: Andrea Goldschmidt, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04057716    
Other Study ID Numbers: STUDY21070047
R01HL147914 ( U.S. NIH Grant/Contract )
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Bulimia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hyperphagia
Signs and Symptoms, Digestive