Insufficient SleepNCT05703347

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

A study testing Fixed sleep goal, Personalized sleep goal and Digital sleep health messaging without virtual study visit in people with Insufficient Sleep and Obesity, run by Children's Hospital of Philadelphia at 1 site in United States.

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Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 12 yearsHealthy volunteers can take part
Conditions the study is for: Insufficient Sleep, Obesity
What is being tested?: Fixed sleep goal, Personalized sleep goal and Digital sleep health messaging without virtual study visit
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,000 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2023to Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 12 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

Show all 10Show fewer

Children using steroids/hormones.
Children regularly taking medications related to exclusionary medical conditions or that impact sleep.
Children with a history of significant behavioral health concerns.
Parent reported PROMIS Parent Proxy Sleep Disturbance - Short Form 8a raw score of ≥28.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jonathan Mitchell, PhD contact

Abby Salem contact

United States1 site, 1 recruiting

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Jonathan Mitchell, PhD, mitchellj2@chop.edu
Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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: Insufficient Sleep, Obesity
Being tested: Fixed sleep goal, Personalized sleep goal, Digital sleep health messaging without virtual study visit, Digital sleep health messaging with virtual study visit, Inactive Parent-Directed Loss-Framed Incentive
Keywords: insufficient sleep, obesity
Medical subject headings: Sleep Deprivation, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fixed sleep goalBehavioural
Investigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.
Personalized sleep goalBehavioural
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 visitBehavioural
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 visitBehavioural
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 IncentiveBehavioural
No parental incentive
Active Parent-Directed Loss-Framed IncentiveBehavioural
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 FeedbackBehavioural
No supportive feedback
Active Supportive FeedbackBehavioural
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 groups in NCT05703347
Study group	Role	What they receive
Condition 1	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 2	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 3	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 4	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 5	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 6	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 7	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 8	Active comparator	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Fixed sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 9	Active comparator	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 10	Active comparator	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 11	Active comparator	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 12	Active comparator	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 13	Active comparator	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 14	Active comparator	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback
Condition 15	Active comparator	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback
Condition 16	Experimental	Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback. Receives: Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in sleep duration
The primary outcome for aims 1 and 3 is change in nighttime sleep duration (hours per night) on weeknights measured by a sleep tracker with high sensitivity and moderate specificity for measuring sleep.
Measured: baseline to 12 months
Change in fat mass index Z-score
Aim 2 primary outcome. Total body fat mass will be measured by DXA. Fat mass index (FMI, kg of fat divided by height in meters squared) will be calculated, and age and gender specific FMI Z-scores will be determined using U.S. specific FMI growth charts.
Measured: Baseline to 12 months

Secondary outcomes (11)

Change in sleep onset
Change in sleep onset (time subject falls asleep). Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in sleep offset
Change in sleep offset (time subject wakes up). Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in sleep midpoint
Change in sleep midpoint. Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in social jetlag
Investigators will calculate "social jetlag" by subtracting the weekend night sleep midpoint from the weeknight sleep midpoint. Social jetlag provides an indication of the discrepancy between internal biological clocks and social requirements and has been linked to cardiometabolic risk.
Measured: up to 12 months
Change in sleep efficiency
Change in sleep efficiency (percentage of time spent asleep during overnight sleep periods). Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in sleep onset latency
Change in sleep onset latency (time to fall asleep). Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in wake after sleep onset
Change in wake after sleep onset (time awake during overnight sleep periods). Weeknights and weekends will be measured separately.
Measured: Baseline to 12 months
Change in sleep disturbance and impairment
Measured using the the Patient-Reported Outcomes Measurement Information System (PROMIS) item bank for pediatric sleep. This validated survey generates a sleep disturbance T-score based on items related to sleep onset, sleep continuity and sleep quality in the past week. The survey also generates a sleep-related impairment T-score based on items related to daytime sleepiness, cognition, affect and behavior, and daytime activities in the past week. Higher T-scores indicates poorer sleep quality. Participants will complete this survey at baseline and at the end of each month during the intervention and follow-up periods.
Measured: Baseline to 12 months
Change in visceral adipose tissue
Visceral adipose tissue area will be measured by DXA.
Measured: Baseline to 12 months
Change in Body Mass Index (BMI)
Trained Nutrition Core staff will measure heights and weights of participants. These data will be used to calculate body mass index (kg/m2).
Measured: Baseline to 12 months
Change in waist circumference
Investigators will measure waist circumferences at baseline, 6-months, and 12-months.
Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 2023Jun 2027

First posted30 Jan 2023
Study start21 Sep 2023
Primary completionJun 2027 (estimated)
Study completionJun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Insufficient SleepStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: 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.
Masking: Single blind
Who is masked: Investigator
Enrolment: 5,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05703347
Sponsor's protocol ID: 22-019805
Other IDs: 1R01HD108243-01
Status last verified: May 2026
First submitted: 12 Sep 2022
Last updated: 27 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27515136
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.
PubMed 26122812
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.
PubMed 29401314
Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17.
PubMed 22608008
Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16.
PubMed 30905623
Honaker SM, Meltzer LJ. Sleep in pediatric primary care: A review of the literature. Sleep Med Rev. 2016 Feb;25:31-9. doi: 10.1016/j.smrv.2015.01.004. Epub 2015 Jan 24.
PubMed 26163054
Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233.
PubMed 29059263
Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1.
PubMed 29370154
Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.
PubMed 33981997
Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Ludwick A, Grant SFA, Dinges DF, Zemel BA. Changes in Sleep Duration and Timing During the Middle-to-High School Transition. J Adolesc Health. 2020 Dec;67(6):829-836. doi: 10.1016/j.jadohealth.2020.04.024. Epub 2020 Jun 20.
PubMed 32576483
Mayne SL, Morales KH, Williamson AA, Grant SFA, Fiks AG, Basner M, Dinges DF, Zemel BS, Mitchell JA. Associations of the residential built environment with adolescent sleep outcomes. Sleep. 2021 Jun 11;44(6):zsaa276. doi: 10.1093/sleep/zsaa276.
PubMed 33507268
Mitchell JA, Rodriguez D, Schmitz KH, Audrain-McGovern J. Sleep duration and adolescent obesity. Pediatrics. 2013 May;131(5):e1428-34. doi: 10.1542/peds.2012-2368. Epub 2013 Apr 8.
PubMed 23569090
Paruthi S, Brooks LJ, D'Ambrosio C, Hall WA, Kotagal S, Lloyd RM, Malow BA, Maski K, Nichols C, Quan SF, Rosen CL, Troester MM, Wise MS. Consensus Statement of the American Academy of Sleep Medicine on the Recommended Amount of Sleep for Healthy Children: Methodology and Discussion. J Clin Sleep Med. 2016 Nov 15;12(11):1549-1561. doi: 10.5664/jcsm.6288.
PubMed 27707447
Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
PubMed 26551999
Meltzer LJ, Williamson AA, Mindell JA. Pediatric sleep health: It matters, and so does how we define it. Sleep Med Rev. 2021 Jun;57:101425. doi: 10.1016/j.smrv.2021.101425. Epub 2021 Jan 19.
PubMed 33601324

Interested in taking part?

Jonathan Mitchell, PhD

2674261473

mitchellj2@chop.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children
ClinicalTrials.gov ID: NCT05703347
Acronym / sponsor ID: 22-019805
Conditions: Insufficient Sleep, Obesity
Keywords: insufficient sleep, obesity
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 5,000 participants (estimated)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Pennsylvania
Study start: 21 Sep 2023 (actual)
Primary completion: Jun 2027 (estimated)
Study completion: Jun 2027 (estimated)
First posted: 30 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (investigator)
Number of arms: 16
Model description: 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.

Arm	Type	Receives
Condition 1	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 2	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 3	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 4	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 5	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 6	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 7	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 8	Active comparator	Behavioral: Fixed sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackFixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 9	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 10	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 11	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 12	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging without virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 13	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 14	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Inactive Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 15	Active comparator	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Inactive Supportive FeedbackPersonalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 16	Experimental	Behavioral: Personalized sleep goal, Behavioral: Digital sleep health messaging with virtual study visit, Behavioral: Active Parent-Directed Loss-Framed Incentive, Behavioral: Active Supportive FeedbackCore intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fixed sleep goalInvestigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.	Behavioural	Condition 1, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8
Personalized sleep goalInvestigators 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.	Behavioural	Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 9
Digital sleep health messaging without virtual study visitAll 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.	Behavioural	Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 3, Condition 4, Condition 9
Digital sleep health messaging with virtual study visitAll 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.	Behavioural	Condition 13, Condition 14, Condition 15, Condition 16, Condition 5, Condition 6, Condition 7, Condition 8
Inactive Parent-Directed Loss-Framed IncentiveNo parental incentive	Behavioural	Condition 1, Condition 10, Condition 13, Condition 14, Condition 2, Condition 5, Condition 6, Condition 9
Active Parent-Directed Loss-Framed IncentiveParents 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.	Behavioural	Condition 11, Condition 12, Condition 15, Condition 16, Condition 3, Condition 4, Condition 7, Condition 8
Inactive Supportive FeedbackNo supportive feedback	Behavioural	Condition 1, Condition 11, Condition 13, Condition 15, Condition 3, Condition 5, Condition 7, Condition 9
Active Supportive FeedbackParticipants 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.	Behavioural	Condition 10, Condition 12, Condition 14, Condition 16, Condition 2, Condition 4, Condition 6, Condition 8

Primary outcome

Change in sleep duration
Time frame: baseline to 12 months
The primary outcome for aims 1 and 3 is change in nighttime sleep duration (hours per night) on weeknights measured by a sleep tracker with high sensitivity and moderate specificity for measuring sleep.
Change in fat mass index Z-score
Time frame: Baseline to 12 months
Aim 2 primary outcome. Total body fat mass will be measured by DXA. Fat mass index (FMI, kg of fat divided by height in meters squared) will be calculated, and age and gender specific FMI Z-scores will be determined using U.S. specific FMI growth charts.

11 secondary outcomes

Change in sleep onset
Time frame: Baseline to 12 months
Change in sleep offset
Time frame: Baseline to 12 months
Change in sleep midpoint
Time frame: Baseline to 12 months
Change in social jetlag
Time frame: up to 12 months
Change in sleep efficiency
Time frame: Baseline to 12 months
Change in sleep onset latency
Time frame: Baseline to 12 months
Change in wake after sleep onset
Time frame: Baseline to 12 months
Change in sleep disturbance and impairment
Time frame: Baseline to 12 months
Change in visceral adipose tissue
Time frame: Baseline to 12 months
Change in Body Mass Index (BMI)
Time frame: Baseline to 12 months
Change in waist circumference
Time frame: Baseline to 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
Background: PubMed 27515136Steinberger 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.
Background: PubMed 26122812Daniels 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.
Background: PubMed 29401314Miller 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.
Background: PubMed 22608008Hatori M, Vollmers C, Zarrinpar A, DiTacchio L, Bushong EA, Gill S, Leblanc M, Chaix A, Joens M, Fitzpatrick JA, Ellisman MH, Panda S. Time-restricted feeding without reducing caloric intake prevents metabolic diseases in mice fed a high-fat diet. Cell Metab. 2012 Jun 6;15(6):848-60. doi: 10.1016/j.cmet.2012.04.019. Epub 2012 May 17.
Background: PubMed 30905623Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16.
Background: PubMed 26163054Honaker SM, Meltzer LJ. Sleep in pediatric primary care: A review of the literature. Sleep Med Rev. 2016 Feb;25:31-9. doi: 10.1016/j.smrv.2015.01.004. Epub 2015 Jan 24.
Background: PubMed 29059263Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233.
Background: PubMed 29370154Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1.
Background: PubMed 33981997Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Eck C, Jawahar A, Juste L, Fiks AG, Zemel BS, Dinges DF. Engineering a mobile platform to promote sleep in the pediatric primary care setting. Sleep Adv. 2021 Apr 15;2(1):zpab006. doi: 10.1093/sleepadvances/zpab006. eCollection 2021.
Background: PubMed 32576483Mitchell JA, Morales KH, Williamson AA, Huffnagle N, Ludwick A, Grant SFA, Dinges DF, Zemel BA. Changes in Sleep Duration and Timing During the Middle-to-High School Transition. J Adolesc Health. 2020 Dec;67(6):829-836. doi: 10.1016/j.jadohealth.2020.04.024. Epub 2020 Jun 20.
Background: PubMed 33507268Mayne SL, Morales KH, Williamson AA, Grant SFA, Fiks AG, Basner M, Dinges DF, Zemel BS, Mitchell JA. Associations of the residential built environment with adolescent sleep outcomes. Sleep. 2021 Jun 11;44(6):zsaa276. doi: 10.1093/sleep/zsaa276.
Background: PubMed 23569090Mitchell JA, Rodriguez D, Schmitz KH, Audrain-McGovern J. Sleep duration and adolescent obesity. Pediatrics. 2013 May;131(5):e1428-34. doi: 10.1542/peds.2012-2368. Epub 2013 Apr 8.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Jonathan Mitchell, PhD contact

Abby Salem contact

Jonathan Mitchell, PhD principal investigator

Children's Hospital of Philadelphia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jonathan Mitchell, PhD (2674261473, mitchellj2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in sleep duration (time frame: baseline to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703347, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.