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

Not Applicable

Recruiting

• Conditions: Obesity; Insufficient Sleep
• Interventions: Behavioral: Fixed sleep goal; Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging without virtual study visit; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Inactive Parent-Directed Loss-Framed Incentive; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Inactive Supportive Feedback; Behavioral: Active Supportive Feedback

• Registration Number: NCT05703347
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-30
• Study Start: 2023-09-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Primary Completion: 2027-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Condition 3	Inactive Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 1	Inactive Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 1	Inactive Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 2	Digital sleep health messaging without virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 2	Inactive Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 3	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 1	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 1	Digital sleep health messaging without virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 2	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 3	Digital sleep health messaging without virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 2	Active Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 4	Digital sleep health messaging without virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 3	Active Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 4	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 4	Active Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 4	Active Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 7	Active Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 8	Digital sleep health messaging with virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 10	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 5	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 5	Digital sleep health messaging with virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 5	Inactive Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 8	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 5	Inactive Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 6	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 6	Inactive Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 6	Active Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 7	Inactive Supportive Feedback	Fixed 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 Parent-Directed Loss-Framed Incentive	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 9	Inactive Supportive Feedback	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 10	Inactive Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 11	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 11	Inactive Supportive Feedback	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 6	Digital sleep health messaging with virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 7	Fixed sleep goal	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 9	Digital sleep health messaging without virtual study visit	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 9	Inactive Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 10	Digital sleep health messaging without virtual study visit	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 10	Active Supportive Feedback	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 11	Active Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 7	Digital sleep health messaging with virtual study visit	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 14	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 16	Digital sleep health messaging with virtual study visit	Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
Condition 8	Active Supportive Feedback	Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 9	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 12	Digital sleep health messaging without virtual study visit	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 12	Active Supportive Feedback	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 13	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 13	Digital sleep health messaging with virtual study visit	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 13	Inactive Supportive Feedback	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 14	Inactive Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 15	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 16	Personalized sleep goal	Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
Condition 11	Digital sleep health messaging without virtual study visit	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 14	Active Supportive Feedback	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 15	Inactive Supportive Feedback	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 12	Personalized sleep goal	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 16	Active Supportive Feedback	Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
Condition 12	Active Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 13	Inactive Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 14	Digital sleep health messaging with virtual study visit	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
Condition 15	Digital sleep health messaging with virtual study visit	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 15	Active Parent-Directed Loss-Framed Incentive	Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
Condition 16	Active Parent-Directed Loss-Framed Incentive	Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.

Primary Outcome Measures

Name	Time	Method
Change in fat mass index Z-score	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.
Change in sleep duration	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.

Secondary Outcome Measures

Name	Time	Method
Change in sleep onset latency	Baseline to 12 months	Change in sleep onset latency (time to fall asleep). Weeknights and weekends will be measured separately.
Change in sleep midpoint	Baseline to 12 months	Change in sleep midpoint. Weeknights and weekends will be measured separately.
Change in sleep efficiency	Baseline to 12 months	Change in sleep efficiency (percentage of time spent asleep during overnight sleep periods). Weeknights and weekends will be measured separately.
Change in wake after sleep onset	Baseline to 12 months	Change in wake after sleep onset (time awake during overnight sleep periods). Weeknights and weekends will be measured separately.
Change in sleep onset	Baseline to 12 months	Change in sleep onset (time subject falls asleep). Weeknights and weekends will be measured separately.
Change in social jetlag	up to 12 months	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.
Change in waist circumference	Baseline to 12 months	Investigators will measure waist circumferences at baseline, 6-months, and 12-months.
Change in sleep disturbance and impairment	Baseline to 12 months	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.
Change in sleep offset	Baseline to 12 months	Change in sleep offset (time subject wakes up). Weeknights and weekends will be measured separately.
Change in visceral adipose tissue	Baseline to 12 months	Visceral adipose tissue area will be measured by DXA.
Change in Body Mass Index (BMI)	Baseline to 12 months	Trained Nutrition Core staff will measure heights and weights of participants. These data will be used to calculate body mass index (kg/m2).

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States