Project REST: Regulation of Eating and Sleep Topography

Sleep Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04057716
• Other study ID #: STUDY21070047
• Secondary ID: R01HL147914
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: University of Pittsburgh
• Contact: Erin Stalvey, B.S.
• Phone: 412-586-9066
• Email: stalveyer[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Sleep restriction
Participants will be asked to restrict their time in bed to 8 hours each night for one week.
• Sleep extension
Participants will be asked to extend their time in bed to 11 hours each night for one week.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Weight Control & Diabetes Research Center	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight Status	BMI (body mass index)	4 weeks
Primary	Change in Eating Behavior	measured by 24-hour dietary recall	4 weeks
Primary	Change in Eating Behavior	measured by ecological momentary assessment	4 weeks
Primary	Self-Regulatory Control	as measured by the Go/No-Go task (errors and response latency)	4 weeks
Secondary	Sleep Patterns	as measured by actigraph data	2 weeks

External Links

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