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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Fixed sleep goal
  Investigators will determine if a fixed guideline-based goal (≥9 hours per night) is more efficacious for increasing sleep duration.
• Поведенческое Personalized 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.
• Поведенческое Digital 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.
• Поведенческое Digital 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.
• Поведенческое Inactive Parent-Directed Loss-Framed Incentive
  No parental incentive
• Поведенческое Active 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 a
• Поведенческое Inactive Supportive Feedback
  No supportive feedback
• Поведенческое Active 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.

Первичные конечные точки

• Change in sleep duration [Срок оценки: baseline to 12 months]
• Change in fat mass index Z-score [Срок оценки: Baseline to 12 months]

Вторичные конечные точки (11)

• Change in sleep onset [Срок оценки: Baseline to 12 months]
• Change in sleep offset [Срок оценки: Baseline to 12 months]
• Change in sleep midpoint [Срок оценки: Baseline to 12 months]
• Change in social jetlag [Срок оценки: up to 12 months]
• Change in sleep efficiency [Срок оценки: Baseline to 12 months]
• Change in sleep onset latency [Срок оценки: Baseline to 12 months]
• Change in wake after sleep onset [Срок оценки: Baseline to 12 months]
• Change in sleep disturbance and impairment [Срок оценки: Baseline to 12 months]
• Change in visceral adipose tissue [Срок оценки: Baseline to 12 months]
• Change in Body Mass Index (BMI) [Срок оценки: Baseline to 12 months]
• Change in waist circumference [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Children's Hospital of Philadelphia — Philadelphia

Публикации

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• Wong CA, Miller VA, Murphy K, Small D, Ford CA, Willi SM, Feingold J, Morris A, Ha YP, Zhu J, Wang W, Patel MS. Effect of Financial Incentives on Glucose Monitoring Adherence and Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA Pediatr. 2017 Dec 1;171(12):1176-1183. doi: 10.1001/jamapediatrics.2017.3233. PMID 29059263
• Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1. PMID 29370154

Идентификаторы

NCT: NCT05703347 · 22-019805 · 1R01HD108243-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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