Optimizing a Mobile Health Platform for Sleep Promotion and Obesity Prevention in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Change in fat mass index Z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 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.
研究组 & 干预措施
Condition 2
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 2
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 12
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 1
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 1
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 1
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 1
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 9
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 9
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 2
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 2
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 3
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 3
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 3
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 3
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 4
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 4
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 4
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 4
Fixed guideline-based sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 5
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 9
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 5
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 5
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 5
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 6
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 6
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 6
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 6
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 7
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 7
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 7
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 7
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 8
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Fixed sleep goal (Behavioral)
Condition 8
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 8
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 8
Fixed guideline-based sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 9
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 10
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 10
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 10
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 10
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 11
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 11
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 11
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 11
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 12
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 12
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging without virtual study visit (Behavioral)
Condition 12
Personalized sleep goal, Digital sleep health messaging without virtual study visit consultation, Active caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 13
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 13
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 13
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 13
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 14
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 14
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 14
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Inactive Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 14
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Inactive caregiver-directed loss-framed incentive, Active supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
Condition 15
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 15
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 15
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 15
Personalized sleep goal, Digital sleep health messaging with virtual study visit consultation, Active caregiver-directed loss-framed incentive, Inactive supportive feedback.
干预措施: Inactive Supportive Feedback (Behavioral)
Condition 16
Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
干预措施: Personalized sleep goal (Behavioral)
Condition 16
Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
干预措施: Digital sleep health messaging with virtual study visit (Behavioral)
Condition 16
Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
干预措施: Active Parent-Directed Loss-Framed Incentive (Behavioral)
Condition 16
Core intervention, Sleep goal, Sleep guidance messaging, Caregiver-directed loss-framed incentive, Supportive feedback.
干预措施: Active Supportive Feedback (Behavioral)
结局指标
主要结局
Change in fat mass index Z-score
时间窗: 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
时间窗: 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.
次要结局
- Change in sleep onset latency(Baseline to 12 months)
- Change in sleep midpoint(Baseline to 12 months)
- Change in sleep efficiency(Baseline to 12 months)
- Change in wake after sleep onset(Baseline to 12 months)
- Change in sleep onset(Baseline to 12 months)
- Change in social jetlag(up to 12 months)
- Change in waist circumference(Baseline to 12 months)
- Change in sleep disturbance and impairment(Baseline to 12 months)
- Change in sleep offset(Baseline to 12 months)
- Change in visceral adipose tissue(Baseline to 12 months)
- Change in Body Mass Index (BMI)(Baseline to 12 months)