Project REST: Regulation of Eating and Sleep Topography | Clinical Trial | StuddyBuddy@endsection
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NCT04057716
Project REST: Regulation of Eating and Sleep Topography
Conditions: Obesity, Childhood, Binge Eating, Sleep, Self-regulation
Sex: All
Ages: 8 Years – 12 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: University of Pittsburgh
Location: University of Pittsburgh Pittsburgh Pennsylvania
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.
Eligibility Criteria
Inclusion Criteria:
* at risk for obesity (BMI\>=85th percentile for age and sex OR BMI\>=50th percentile for age and sex with at least one obese parent)
* average time in bed between 9.5-10.5 hours/night
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT04057716). StuddyBuddy aggregates publicly available trial information.