设计一项随机对照试验，以测试中断坐着对超重/肥胖儿童2型糖尿病危险因素的影响：久坐行为研究3方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-21 DOI:10.1016/j.cct.2025.107862

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

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引用次数: 0

摘要

背景：久坐行为在儿童中普遍存在。我们发现，通过打断坐姿，代谢和情感结果在3小时内得到了急性改善。目前尚不清楚急性反应是否在数天内转化为持续或改善的反应。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3组平行组随机对照试验，N = 150（每组50）8-11岁超重/肥胖儿童。在筛选和7-10 天基线自由生活评估后，儿童被随机分配连续7天每天3 小时完成三种实验室条件之一：(1)连续坐着（SIT）；(2)坐着休息，每30 min进行3分钟的中等强度步行（SIT+WALK）；(3)单次18分钟的中等强度步行，然后连续坐着（EX）。在第1天和第7天进行3小时口服葡萄糖耐量试验。在研究期间，参与者还佩戴连续血糖监测仪和加速计，并完成每天24小时的饮食回顾和影响评估。结论：本研究的总体目的是评估中断静坐超过一周对儿童葡萄糖稳态（主要结果）和次要（认知和情感）结果的有效性。如果成功，它将提供新的干预策略，可以转化为其他环境，年龄和体重群体，从而有助于降低美国年轻人2型糖尿病的风险。试验注册：ClinicalTrials.govNCT04469790，注册于2020年7月14日。

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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

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.gov NCT04469790, registered July 14, 2020.

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.