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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05703347
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

Interventions

  • Fixed sleep goal — BEHAVIORAL
    Investigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.
  • Personalized sleep goal — BEHAVIORAL
    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.
  • Digital sleep health messaging without virtual study visit — BEHAVIORAL
    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.
  • Digital sleep health messaging with virtual study visit — BEHAVIORAL
    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.
  • Inactive Parent-Directed Loss-Framed Incentive — BEHAVIORAL
    No parental incentive
  • Active Parent-Directed Loss-Framed Incentive — BEHAVIORAL
    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.
  • Inactive Supportive Feedback — BEHAVIORAL
    No supportive feedback
  • Active Supportive Feedback — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 21, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
5,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Condition 1
    Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 2
    Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 3
    Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 4
    Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 5
    Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 6
    Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 7
    Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 8
    Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 9
    Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 10
    Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 11
    Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 12
    Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 13
    Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Active Comparator: Condition 14
    Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
  • Active Comparator: Condition 15
    Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
  • Experimental: Condition 16
    Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.

Primary Outcome Measure

Change in sleep duration [ Time Frame: baseline to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Jonathan Mitchell, PhD
[email protected]

Find similar trials in Philadelphia, PA

By condition
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By specialty
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By research site
Children's Hospital of Philadelphia· Philadelphia, PA

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