一项针对小学适龄儿童预防夏季体重加速增加的昼夜节律与睡眠聚焦移动健康干预措施的评估：一项随机对照可行性研究方案

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.

作者信息

Moreno Jennette P, Dadabhoy Hafza, Musaad Salma, Baranowski Tom, Thompson Debbe, Alfano Candice A, Crowley Stephanie J

机构信息

Children's Nutrition Research Center, Department of Pediatrics-Nutrition, Baylor College of Medicine, Houston, TX, United States.

Sleep and Anxiety Center of Houston, Department of Psychology, University of Houston, Houston, TX, United States.

出版信息

JMIR Res Protoc. 2022 May 16;11(5):e37002. doi: 10.2196/37002.

DOI:10.2196/37002

PMID:35576573

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9152728/

Abstract

BACKGROUND

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.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04445740; https://clinicaltrials.gov/ct2/show/NCT04445740.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/37002.

摘要

背景

“i♥rhythm项目”是人际与社会节律疗法的移动健康应用，旨在在夏季促进5至8岁儿童的健康睡眠和行为节律，以预防夏季体重加速增加。

目的

这项试点研究将检验“i♥rhythm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运作，并为家庭所接受，为全面的随机对照试验做好准备。拟议的研究将考察参与者参与干预的意愿，并确定在进行全面研究之前是否需要对干预、程序和测量方法进行修改。我们将评估我们在以下方面的能力：（1）招募、征得同意并留住参与者；（2）实施干预；（3）执行研究和评估程序；（4）评估拟议测量方法的可靠性；（5）评估干预和评估方案的可接受性。