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Sleep Management for Childhood Obesity

N/A
Recruiting
Led By Andrea B Goldschmidt, Ph.D.
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Taking medication known to affect sleep/appetite (e.g., antihistamines, stimulants)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will 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.

Who is the study for?
This trial is for children who are overweight or obese and willing to have an MRI scan. It's not suitable for those with conditions affecting brain function, like a recent concussion, more than 10 hours of sleep per night, past eating disorders, sleep or psychiatric conditions, or if they're on medications that affect sleep or appetite.
What is being tested?
Project REST aims to see how changing the amount of sleep can influence children's self-control around eating and their brain activity related to food. The study will test whether more or less sleep affects real-world eating behavior in kids with weight issues.
What are the potential side effects?
Since this trial involves changes in sleeping patterns rather than medication, side effects may include tiredness from lack of sleep during the restriction phase and potential difficulty adjusting to new sleeping schedules.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am taking medication that can affect my sleep or appetite.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Eating Behavior
Change in Weight Status
Self-Regulatory Control
Secondary study objectives
Sleep Patterns

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sleep restriction followed by extensionExperimental Treatment2 Interventions
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.
Group II: Sleep extension followed by restrictionExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep extension
2019
N/A
~220
Sleep restriction
2005
Completed Phase 1
~450

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,866 Total Patients Enrolled
The Miriam HospitalLead Sponsor
245 Previous Clinical Trials
37,778 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,779 Total Patients Enrolled
Andrea B Goldschmidt, Ph.D.Principal InvestigatorUniversity of Pittsburgh
2 Previous Clinical Trials
119 Total Patients Enrolled

Media Library

Sleep extension Clinical Trial Eligibility Overview. Trial Name: NCT04057716 — N/A
Self-Regulation Research Study Groups: Sleep restriction followed by extension, Sleep extension followed by restriction
Self-Regulation Clinical Trial 2023: Sleep extension Highlights & Side Effects. Trial Name: NCT04057716 — N/A
Sleep extension 2023 Treatment Timeline for Medical Study. Trial Name: NCT04057716 — N/A
~9 spots leftby May 2025
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