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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
~180
Sleep restriction
2005
Completed Phase 1
~450

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,722 Previous Clinical Trials
16,342,816 Total Patients Enrolled
14 Trials studying Sleep
1,966 Patients Enrolled for Sleep
The Miriam HospitalLead Sponsor
238 Previous Clinical Trials
37,355 Total Patients Enrolled
5 Trials studying Sleep
892 Patients Enrolled for Sleep
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,850,737 Total Patients Enrolled
31 Trials studying Sleep
56,953 Patients Enrolled for Sleep

Media Library

Sleep extension Clinical Trial Eligibility Overview. Trial Name: NCT04057716 — N/A
Sleep Research Study Groups: Sleep restriction followed by extension, Sleep extension followed by restriction
Sleep 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this trial encompass adults aged 45 and older?

"According to the inclusion criteria listed in this clinical trial, prospective participants must be aged 8-12."

Answered by AI

Is it possible for me to join this experimentation?

"The aim of this trial is to recruit 120 children between the ages 8 and 12 with eating/binge issues who are overweight or obese, right-handed, and willing to participate in a 30-minute MRI."

Answered by AI

What is the participant enrollment size for this clinical research?

"Affirmative. According to the archives on clinicaltrials.gov, this research endeavour is actively looking for volunteers; it was first published on August 15th 2019 and most recently updated on January 28th 2022. This experiment requires 120 test subjects across one medical site."

Answered by AI

Are individuals able to access this clinical experiment at present?

"The clinical trial is currently open for enrollment. Its initial posting was on August 15th 2019, and the last update to its information occurred January 28th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
University of Pittsburgh
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Project REST: Regulation of Eating and Sleep Topography
Andrea Goldschmidt 2019. "Project REST: Regulation of Eating and Sleep Topography". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04057716.
All > Binge Eating
~2 spots leftby May 2024
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