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

NCT05703347 | Recruiting DMC

• 2 other identifiers: 22-0198051R01HD108243-01
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Insufficient Sleep; Obesity

Keywords

insufficient sleep; obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline to 12 months

Secondary Outcomes (11)

• Change in sleep onset

  Baseline to 12 months

• Change in sleep offset

  Baseline to 12 months

• Change in sleep midpoint

  Baseline to 12 months

• Change in social jetlag

  up to 12 months

• Change in sleep efficiency

  Baseline to 12 months

Study Arms (16)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: Personalized sleep goal; Behavioral: Digital sleep health messaging with virtual study visit; Behavioral: Active Parent-Directed Loss-Framed Incentive; Behavioral: Active Supportive Feedback

Interventions

Fixed sleep goal BEHAVIORAL

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

Condition 1; Condition 2; Condition 3; Condition 4; Condition 5; Condition 6; Condition 7; Condition 8

Personalized sleep goal BEHAVIORAL

Investigators will determine if a personalized goal (≥9 hours per night, but can be lowered to a personalized level, capped at +30 minutes per night above baseline) is more efficacious for increasing sleep duration.

Condition 10; Condition 11; Condition 12; Condition 13; Condition 14; Condition 15; Condition 16; Condition 9

Digital sleep health messaging without virtual study visit BEHAVIORAL

All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. This group will NOT have virtual psychological visits.

Condition 1; Condition 10; Condition 11; Condition 12; Condition 2; Condition 3; Condition 4; Condition 9

Digital sleep health messaging with virtual study visit BEHAVIORAL

All participants will receive digital sleep health messaging. Messaging will focus on evidence-based sleep health recommendations, such as regulating evening electronics use, managing extracurricular activities, and setting consistent bedtime routines and sleep-wake schedules. The participants will be randomized to additionally receive virtual study visits where doctoral-level psychology trainees will be trained to implement evidence-based behavioral sleep health guidance.

Condition 13; Condition 14; Condition 15; Condition 16; Condition 5; Condition 6; Condition 7; Condition 8

Inactive Parent-Directed Loss-Framed Incentive BEHAVIORAL

No parental incentive

Condition 1; Condition 10; Condition 13; Condition 14; Condition 2; Condition 5; Condition 6; Condition 9

Active Parent-Directed Loss-Framed Incentive BEHAVIORAL

Parents will receive a financial incentive when their child achieves their sleep goal. The incentive will be loss-framed; parents will receive an endowment of $10 at the start of each intervention week, in a virtual bank account; Investigators will deduct $2 each weeknight the sleep duration goal is not met; the funds remaining in the virtual account will be dispensed each Sunday. The weekly endowment-payment approach allows for fresh starts each week. The incentive will be directed at parents as a method to enhance engagement. Investigators will ask parents at baseline and at the end of each month to rate their perceived support in helping their child to meet their sleep duration goal.

Condition 11; Condition 12; Condition 15; Condition 16; Condition 3; Condition 4; Condition 7; Condition 8

Inactive Supportive Feedback BEHAVIORAL

No supportive feedback

Condition 1; Condition 11; Condition 13; Condition 15; Condition 3; Condition 5; Condition 7; Condition 9

Active Supportive Feedback BEHAVIORAL

Participants will receive a weekly performance summary message each Sunday during the intervention period, with supportive feedback included to motivate children to maintain their good performance in the week ahead, or to try and improve upon a weak or moderate performance in the week ahead. Investigators will ask children will complete an online survey each Sunday to measure how motivated they are to achieve their sleep goal in the week ahead.

Condition 10; Condition 12; Condition 14; Condition 16; Condition 2; Condition 4; Condition 6; Condition 8

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Children using steroids/hormones.
• Children regularly taking medications

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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MeSH Terms

Conditions

Sleep Deprivation; Obesity

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Jonathan Mitchell, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Mitchell, PhD

CONTACT

2674261473; mitchellj2@chop.edu

Abby Salem

CONTACT

2155902386; salema1@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: January 30, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)