Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
5,000 participants in 16 patient groups
Trial contacts and locations
Loading...
Central trial contact
Abby Salem; Jonathan Mitchell, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal