Evaluation of a Circadian Rhythm and Sleep-Focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School-Age Children: Protocol for a Randomized Controlled Feasibility Study.
Evaluation of a Circadian Rhythm and Sleep-Focused Mobile Health Intervention for the Prevention of Accelerated Summer Weight Gain Among Elementary School-Age Children: Protocol for a Randomized Controlled Feasibility Study.
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DOI：
10.2196/37002
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发表时间：
2022-05-16
影响因子：
1.7
通讯作者：
Crowley, Stephanie J.
中科院分区：
文献类型：
--
作者：
Moreno, Jennette P.;Dadabhoy, Hafza;Musaad, Salma;Baranowski, Tom;Thompson, Debbe;Alfano, Candice A.;Crowley, Stephanie J.
间歇性节律项目是一种移动的健康适应性人际和社会节律疗法，旨在促进5-8岁奥尔兹在夏季的健康睡眠和行为节律，以防止夏季体重加速增加。该试点研究将检查心律失常干预的可行性、可接受性和初步疗效。这将确保研究方案和程序按预期工作，并为家庭接受，为充分把握度的随机对照试验做准备。拟定研究将检查受试者参与干预的意愿，并确定在进行完全把握度研究之前是否需要修改干预、程序和措施。我们将评估我们在以下方面的能力：（1）招募、同意和保留受试者;（2）提供干预;（3）实施研究和评估程序;（4）评估拟议措施的可靠性;（5）评估干预和评估方案的可接受性。本研究将采用单盲2组随机对照设计（治疗和非治疗对照），在基线（时间0）和3个额外评价期（干预后[时间1]、干预后9个月[时间2]和12个月[时间3]）后进行随机化。将招募40个亲子配对样本。本研究由贝勒医学院的机构审查委员会批准（H-47369）。招聘工作于2021年3月开始。截至2022年3月，数据收集和招募工作仍在进行中。这项研究将探讨睡眠和昼夜节律在预防夏季体重增加加速中的作用，并评估干预措施对长期预防儿童肥胖的影响。ClinicalTrials.gov NCT 04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. DERR1-10.2196/37002
The i♥rhythm project is a mobile health adaptation of interpersonal and social rhythm therapy designed to promote healthy sleep and behavioral rhythms among 5-8-year olds during summer for the prevention of accelerated summer weight gain. This pilot study will examine the feasibility, acceptability, and preliminary efficacy of the i♥rhythm intervention. This will ensure that the research protocol and procedures work as desired and are acceptable to families in preparation for the fully powered randomized controlled trial. The proposed study will examine the willingness of participants to participate in the intervention and determine whether modifications to the intervention, procedures, and measures are needed before conducting a fully powered study. We will assess our ability to (1) recruit, consent, and retain participants; (2) deliver the intervention; (3) implement the study and assessment procedures; (4) assess the reliability of the proposed measures; and (5) assess the acceptability of the intervention and assessment protocol. This study will employ a single-blinded 2-group randomized control design (treatment and no-treatment control) with randomization occurring after baseline (Time 0) and 3 additional evaluation periods (postintervention [Time 1], and 9 months [Time 2] and 12 months after intervention [Time 3]). A sample of 40 parent-child dyads will be recruited. This study was approved by the institutional review board of Baylor College of Medicine (H-47369). Recruitment began in March 2021. As of March 2022, data collection and recruitment are ongoing. This study will address the role of sleep and circadian rhythms in the prevention of accelerated summer weight gain and assess the intervention’s effects on the long-term prevention of child obesity. ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740. DERR1-10.2196/37002
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影响因子：
5
作者：
COHEN, S;KAMARCK, T;MERMELSTEIN, R
通讯作者：
MERMELSTEIN, R
影响因子：
4.2
作者：
Baranowski, T;Stables, G
通讯作者：
Stables, G
影响因子：
4.5
作者：
Chen TA;Baranowski T;Moreno JP;O'Connor TM;Hughes SO;Baranowski J;Woehler D;Kimbro RT;Johnston CA
通讯作者：
Johnston CA
影响因子：
3.8
作者：
Chen, T. -A.;Baranowski, T.;Johnston, C. A.
通讯作者：
Johnston, C. A.
DOI：
10.1136/bmj.e7586
发表时间：
2013-01-08
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Chan AW;Tetzlaff JM;Gøtzsche PC;Altman DG;Mann H;Berlin JA;Dickersin K;Hróbjartsson A;Schulz KF;Parulekar WR;Krleza-Jeric K;Laupacis A;Moher D
通讯作者：
Moher D