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一项随机对照试验的设计,旨在测试中断久坐对超重/肥胖儿童2型糖尿病风险因素的影响:久坐行为研究3方案

Design of a randomized controlled trial to test the efficacy of interrupting sitting on type 2 diabetes risk factors in children with overweight/obesity: The sedentary behavior study 3 protocol.

作者信息

Belcher B R, McAlister K L, Zink J, Chapman T M, Moore K N, Castillo S, Hewus M, Kaslander J N, Dieli-Conwright C M, Huh J, Page K A

机构信息

Department of Population and Public Health Sciences, Keck School of Medicine of USC, University of Southern California, 1845 N. Soto Street, Los Angeles, CA 90032, USA..

Health Behaviors Research Branch, Behavioral Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, National Institutes of Health, 9609 Medical Center Drive, Rockville, MD 20850, USA..

出版信息

Contemp Clin Trials. 2025 May;152:107862. doi: 10.1016/j.cct.2025.107862. Epub 2025 Feb 21.

DOI:10.1016/j.cct.2025.107862
PMID:39987963
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11994285/
Abstract

BACKGROUND

Sedentary behaviors are pervasive in children. We found acute 3-h improvements in metabolic and affective outcomes by interrupting sitting. It is unknown whether acute responses translate to sustained or improved responses over multiple days. This paper describes the rationale, study design, recruitment, data collection, and data analytic protocols for the Sedentary Behavior Study 3 (SBS3).

METHODS

This is a 3-arm parallel-group randomized controlled trial of N = 150 (50 per group) 8-11-year-old children with overweight/obesity. Following screening and 7-10 day baseline free-living assessment, children are randomly assigned to complete one of three in-lab conditions for 3 h/day for 7 consecutive days: (1) continuous sitting (SIT); (2) sitting interrupted by 3-min bouts of moderate-intensity walking every 30 min (SIT+WALK); or (3) a single 18-min bout of moderate-intensity walking followed by continuous sitting (EX). Three-hour oral glucose tolerance tests are conducted on Days 1 and 7. Participants also wear continuous glucose monitors and accelerometers for the duration of the study, and complete daily 24-h dietary recalls and affective assessments.

CONCLUSIONS

The overall aim of this study is to evaluate the effectiveness of interrupting sitting over one week on glucose homeostasis (primary outcome) and secondary (cognitive and affective) outcomes in children. If successful, it will provide novel intervention strategies that can be translated to other settings, and age and weight groups, thereby contributing to efforts at reducing type 2 diabetes risk in U.S. youth.

TRIAL REGISTRATION

ClinicalTrials.govNCT04469790, registered July 14, 2020.

摘要

背景

久坐行为在儿童中普遍存在。我们发现通过中断坐姿,可在3小时内使代谢和情感指标得到急性改善。目前尚不清楚这种急性反应是否能转化为多日的持续或改善反应。本文介绍了久坐行为研究3(SBS3)的基本原理、研究设计、招募、数据收集和数据分析方案。

方法

这是一项三臂平行组随机对照试验,纳入150名(每组50名)8至11岁超重/肥胖儿童。经过筛查和7至10天的基线自由生活评估后,儿童被随机分配,连续7天每天在实验室完成以下三种条件之一,时长为3小时:(1)持续坐着(SIT);(2)每30分钟被3分钟中等强度步行打断的坐姿(SIT+WALK);或(3)单次18分钟中等强度步行后持续坐着(EX)。在第1天和第7天进行3小时口服葡萄糖耐量试验。参与者在研究期间还佩戴连续血糖监测仪和加速度计,并完成每日24小时饮食回忆和情感评估。

结论

本研究的总体目标是评估在一周内中断坐姿对儿童葡萄糖稳态(主要结局)和次要(认知和情感)结局的有效性。如果成功,将提供可转化到其他环境以及不同年龄和体重组的新型干预策略,从而有助于降低美国青少年2型糖尿病风险。

试验注册

ClinicalTrials.govNCT04469790,于2020年7月14日注册。

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Effects of interrupting daily sedentary behavior on children's glucose metabolism: A 6-day randomized controlled trial.中断日常久坐行为对儿童葡萄糖代谢的影响:一项 6 天随机对照试验。
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