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

NCT ID: NCT05703347

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-21

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Insufficient sleep duration is highly prevalent in childhood and is associated with incident obesity, especially among middle school-aged children. Investigators therefore need to identify strategies to increase sleep duration among children for obesity prevention. 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. This is a single-site study being conducted at the Children's Hospital of Philadelphia (CHOP). Investigators will randomize 325 children, aged 8-12y, with a body mass index (BMI) between the 50th-95th percentile, and who sleep \<8.5 hours per night. Clinical measurements will be acquired at CHOP and sleep will be measured in the home setting. The Way to Health mobile platform will facilitate remote communication and data collection. A validated multi-channel sleep tracker will estimate sleep for 12-months (2-week run-in; 6-month intervention; ≈5.5-month follow-up). A randomized 24 factorial design will assess four components: sleep goal (fixed or modifiable), digital guidance (active or active with virtual study visit), parent incentive (inactive or active), and personalized feedback (inactive or active). The optimal component settings will have to meet the following criteria: increase average baseline sleep duration by ≥30 minutes for ≥75% of intervention weeks and for ≥50% of follow-up weeks. Fat mass will be measured at baseline, 6-, and 12-months using dual energy X-ray absorptiometry (DXA). Total energy intake and the timing and composition of meals will be measured using 24-hour dietary recalls at baseline, 6-, and 12-months. Sociodemographic data will be measured using self-report approaches (e.g., sex, race/ethnicity) and home addresses will be geocoded for geo-spatial analyses.

Conditions

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Insufficient Sleep Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

A computerized random number generated by the Way to Health platform will assign children to 1 of 16 study conditions for a 6-month intervention period. The study conditions differ with respect to: sleep goal (fixed or modifiable), digital sleep guidance (active or active with virtual study visit), parent-directed incentive (inactive or active), and personalized feedback (inactive or active). Our design includes one constant: all participants need to self-monitor their sleep duration by wearing the sleep tracker to allow for daily capture of sleep duration and goal achievement status. The intervention period is therefore designed to test the effectiveness of 4 components, each with two levels, using a factorial design.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Investigators will be blinded, except the psychologist on the team who needs to train and direct the virtual study visit delivery for one of the intervention components.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging without virtual study visit

Intervention Type 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.

Inactive Parent-Directed Loss-Framed Incentive

Intervention Type BEHAVIORAL

No parental incentive

Inactive Supportive Feedback

Intervention Type BEHAVIORAL

No supportive feedback

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging without virtual study visit

Intervention Type 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.

Inactive Parent-Directed Loss-Framed Incentive

Intervention Type BEHAVIORAL

No parental incentive

Active Supportive Feedback

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging without virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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

Intervention Type BEHAVIORAL

No supportive feedback

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging without virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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.

Active Supportive Feedback

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging with virtual study visit

Intervention Type 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

Intervention Type BEHAVIORAL

No parental incentive

Inactive Supportive Feedback

Intervention Type BEHAVIORAL

No supportive feedback

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging with virtual study visit

Intervention Type 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

Intervention Type BEHAVIORAL

No parental incentive

Active Supportive Feedback

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging with virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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

Intervention Type BEHAVIORAL

No supportive feedback

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.

Group Type ACTIVE_COMPARATOR

Fixed sleep goal

Intervention Type BEHAVIORAL

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

Digital sleep health messaging with virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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.

Active Supportive Feedback

Intervention Type 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.

Condition 9

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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

Intervention Type 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.

Inactive Parent-Directed Loss-Framed Incentive

Intervention Type BEHAVIORAL

No parental incentive

Inactive Supportive Feedback

Intervention Type BEHAVIORAL

No supportive feedback

Condition 10

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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

Intervention Type 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.

Inactive Parent-Directed Loss-Framed Incentive

Intervention Type BEHAVIORAL

No parental incentive

Active Supportive Feedback

Intervention Type 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.

Condition 11

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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

Intervention Type BEHAVIORAL

No supportive feedback

Condition 12

Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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.

Active Supportive Feedback

Intervention Type 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.

Condition 13

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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 with virtual study visit

Intervention Type 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

Intervention Type BEHAVIORAL

No parental incentive

Inactive Supportive Feedback

Intervention Type BEHAVIORAL

No supportive feedback

Condition 14

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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 with virtual study visit

Intervention Type 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

Intervention Type BEHAVIORAL

No parental incentive

Active Supportive Feedback

Intervention Type 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.

Condition 15

Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.

Group Type ACTIVE_COMPARATOR

Personalized sleep goal

Intervention Type 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 with virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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

Intervention Type BEHAVIORAL

No supportive feedback

Condition 16

Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.

Group Type EXPERIMENTAL

Personalized sleep goal

Intervention Type 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 with virtual study visit

Intervention Type 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.

Active Parent-Directed Loss-Framed Incentive

Intervention Type 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.

Active Supportive Feedback

Intervention Type 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.

Interventions

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Fixed sleep goal

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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Inactive Parent-Directed Loss-Framed Incentive

No parental incentive

Intervention Type 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.

Intervention Type BEHAVIORAL

Inactive Supportive Feedback

No supportive feedback

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Mitchell, PhD

Role: CONTACT

2674261473

Abby Salem

Role: CONTACT

2155902386

Facility Contacts

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Jonathan Mitchell, PhD

Role: primary

References

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Steinberger J, Daniels SR, Hagberg N, Isasi CR, Kelly AS, Lloyd-Jones D, Pate RR, Pratt C, Shay CM, Towbin JA, Urbina E, Van Horn LV, Zachariah JP; American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee of the Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Functional Genomics and Translational Biology; and Stroke Council. Cardiovascular Health Promotion in Children: Challenges and Opportunities for 2020 and Beyond: A Scientific Statement From the American Heart Association. Circulation. 2016 Sep 20;134(12):e236-55. doi: 10.1161/CIR.0000000000000441. Epub 2016 Aug 11.

Reference Type BACKGROUND
PMID: 27515136 (View on PubMed)

Daniels SR, Hassink SG; COMMITTEE ON NUTRITION. The Role of the Pediatrician in Primary Prevention of Obesity. Pediatrics. 2015 Jul;136(1):e275-92. doi: 10.1542/peds.2015-1558. Epub 2015 Jun 29.

Reference Type BACKGROUND
PMID: 26122812 (View on PubMed)

Miller MA, Kruisbrink M, Wallace J, Ji C, Cappuccio FP. Sleep duration and incidence of obesity in infants, children, and adolescents: a systematic review and meta-analysis of prospective studies. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy018.

Reference Type BACKGROUND
PMID: 29401314 (View on PubMed)

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01HD108243-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-019805

Identifier Type: -

Identifier Source: org_study_id

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