RecruitingNot ApplicableNCT05703347

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


Sponsor

Children's Hospital of Philadelphia

Enrollment

5,000 participants

Start Date

Sep 21, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 8 YearsMax Age: 12 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

BEHAVIORALFixed sleep goal

Investigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.

BEHAVIORALPersonalized sleep goal

Investigators will determine if a personalized goal (≥9 hours per night, but can be lowered to a personalized level, capped at +30 minutes per night above baseline) is more efficacious for increasing sleep duration.

BEHAVIORALDigital sleep health messaging without virtual study visit

All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. This group will NOT have virtual psychological visits.

BEHAVIORALDigital sleep health messaging with virtual study visit

All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. The participants will be randomized to additionally receive virtual study visits where doctoral-level psychology trainees will be trained to implement evidence-based behavioral sleep health guidance.

BEHAVIORALInactive Parent-Directed Loss-Framed Incentive

No parental incentive

BEHAVIORALActive Parent-Directed Loss-Framed Incentive

Parents will receive a financial incentive when their child achieves their sleep goal. The incentive will be loss-framed; parents will receive an endowment of $10 at the start of each intervention week, in a virtual bank account; Investigators will deduct $2 each weeknight the sleep duration goal is not met; the funds remaining in the virtual account will be dispensed each Sunday. The weekly endowment-payment approach allows for fresh starts each week. The incentive will be directed at parents as a method to enhance engagement. Investigators will ask parents at baseline and at the end of each month to rate their perceived support in helping their child to meet their sleep duration goal.

BEHAVIORALInactive Supportive Feedback

No supportive feedback

BEHAVIORALActive Supportive Feedback

Participants will receive a weekly performance summary message each Sunday during the intervention period, with supportive feedback included to motivate children to maintain their good performance in the week ahead, or to try and improve upon a weak or moderate performance in the week ahead. Investigators will ask children will complete an online survey each Sunday to measure how motivated they are to achieve their sleep goal in the week ahead.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT05703347


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