Insufficient Sleep, Obesity
Conditions
Keywords
insufficient sleep, obesity
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.
Interventions
BEHAVIORALFixed sleep goal
Investigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.
BEHAVIORALPersonalized 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.
BEHAVIORALDigital 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.
BEHAVIORALDigital 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.
BEHAVIORALInactive Parent-Directed Loss-Framed Incentive
No parental incentive
BEHAVIORALActive 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.
BEHAVIORALInactive Supportive Feedback
No supportive feedback
BEHAVIORALActive 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.
Sponsors
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
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 related to exclusionary medical conditions or that impact sleep. 9. Children with a history of significant behavioral health concerns. 10. Parent reported PROMIS Parent Proxy Sleep Disturbance - Short Form 8a raw score of ≥28.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 sleep offset | Baseline to 12 months | Change in sleep offset (time subject wakes up). 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 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 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 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 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 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 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). |
| Change in waist circumference | Baseline to 12 months | Investigators will measure waist circumferences at baseline, 6-months, and 12-months. |
Countries
United States
Contacts
CONTACTJonathan Mitchell, PhD
CONTACTAbby Salem
PRINCIPAL_INVESTIGATORJonathan Mitchell, PhD
Children's Hospital of Philadelphia
Outcome results
None listed