Mobile health platform to improve sleep and prevent obesity in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to develop a mobile health platform designed for pediatric care to promote longer sleep duration as a strategy for preventing obesity in children. It will involve randomizing 325 children aged 8-12 years, who currently sleep less than 8.5 hours per night and have a BMI between the 50th and 95th percentile. The study will utilize a validated sleep tracker to monitor sleep patterns over a 12-month period, incorporating various intervention components such as sleep goals and digital guidance. The effectiveness of these interventions will be assessed based on their ability to increase sleep duration and reduce fat mass in participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Diagnosed with a chronic disease.
2. Diagnosed with a behavioral health problem.
3. Diagnosed with a condition that can impact sleep or growth.
4. Diagnosed with a condition affecting physical growth and maturation or dietary intake.
5. Children with a history of cancer, kidney, GI, musculoskeletal, or sleep disorders.
6. Children who will transition to high-school during the study.
7. Children using steroids/hormones.
8. Children regularly taking medications related to exclusionary medical conditions or that impact sleep.
9. Children with a history of significant behavioral health concerns.
10. Parent reported PROMIS Parent Proxy Sleep Disturbance - Short Form 8a raw score of ≥28.

Where it's running

• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jonathan Mitchell, PhD — Children's Hospital of Philadelphia
• Study coordinator: Jonathan Mitchell, PhD
• Email: mitchellj2@chop.edu
• Phone: 2674261473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.