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

NCT05703347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Fixed sleep goal

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

BEHAVIORAL

Personalized 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.

BEHAVIORAL

Digital 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.

BEHAVIORAL

Digital 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.

BEHAVIORAL

Inactive Parent-Directed Loss-Framed Incentive

No parental incentive

BEHAVIORAL

Active 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.

BEHAVIORAL

Inactive Supportive Feedback

No supportive feedback

BEHAVIORAL

Active 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.

Sponsors & Collaborators

Principal Investigators

  • Jonathan Mitchell, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-21
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05703347 on ClinicalTrials.gov