RecruitingNot Applicable

Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children

United States5,000 participantsStarted 2023-09-21

Plain-language summary

The overall objective of this application is to develop a mobile health platform for the pediatric care setting to promote longer sleep duration for childhood obesity prevention.

Who can participate

Age range

8 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 8-12 years olds.
. Insufficient sleep duration (\<8.5 hours per night).
. Body mass index (BMI) between the 50th and 95th percentile for age and sex.
. One child per family.

Exclusion criteria

. Diagnosed with a chronic disease.
. Diagnosed with a behavioral health problem.
. Diagnosed with a condition that can impact sleep or growth.
. Diagnosed with a condition affecting physical growth and maturation or dietary intake.
. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders.
. Children who will transition to high-school during the study.
. Children using steroids/hormones.
. Children regularly taking medications related to exclusionary medical conditions or that impact sleep.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in sleep duration

Timeframe: baseline to 12 months

Change in fat mass index Z-score

Timeframe: Baseline to 12 months

Trial details

NCT IDNCT05703347

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

Jonathan Mitchell, PhD

2674261473 mitchellj2@chop.edu

View on ClinicalTrials.gov More Insufficient Sleep trials