对抗儿童夏季体重指数加速增加的随机对照剂量反应试验方案：确定结构环境的最佳剂量（dose）研究

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-10 DOI:10.1016/j.cct.2025.107840

Keagan P. Kiely , Michael W. Beets , Elizabeth L. Adams , Russell R. Pate , Chen Brian , Armstrong Bridget , Burkart Sarah , Aliye B. Cepni , Anthony J. Holmes , James W. White , Finnegan Olivia , Savidge Meghan , Parker Hannah , Griffin A.T. Randolph , Zhu Xuanxuan , R. Glenn Weaver

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引用次数: 0

摘要

背景：夏季是小学适龄儿童身体质量指数（BMI）加速增长的时期。夏令营可以提供一个结构化的环境，这已经被证明可以减缓夏季体重指数的加速增长。其中许多项目都是按服务收费的结构，给低收入家庭造成了经济障碍。提供代金券来支付这些项目可能是解决这一障碍和减轻夏季BMI加速增长的有效策略，但需要进一步调查最佳剂量-看到有意义的结果所需的最小暴露量，同时不过度使用资源。方法采用3个治疗水平的多组随机对照试验。来自参与学校（n = 4）的5-12岁儿童（n = 360）将被随机分配到像往常一样的暑期组（对照组）或获得参加现有夏令营的代金券，为期4周，6周或8周。BMI将在基线（即~ 5月）、3个月（即~ 8月）和12个月（即下学年的~ 5月）进行客观测量。致肥行为（如身体活动、饮食、屏幕时间和睡眠）将在春季（即5月下旬）和夏季（即6月下旬和7月）进行评估。实施因素，如内容，出勤频率，持续时间和覆盖范围，与儿童夏季BMI增加和肥胖行为的关系也将被评估。这项研究还将评价每个期间的成本效益。该研究的结果将确定夏季节目的最佳剂量，以减轻夏季体重指数的过度增加，为有效的公共卫生倡议提供信息，以对抗儿童肥胖。试验注册：NCT06158594https://clinicaltrials.gov/study/NCT06158594?titles=determining%20optimal%20amount%20of%20structured%20environments&rank=1。

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Protocol for a randomized controlled dose response trial to combat accelerated summer BMI gain in children: The determining the optimal amount of structured environments (DOSE) study

Background

Summer is a period of accelerated body mass index (BMI) gain for elementary school-aged children. Summer day camps may provide a structured environment, which has been shown to mitigate accelerated summer BMI gain. Many of these programs have a fee-for-service structure, creating a financial barrier for families with low-income. Providing vouchers to pay for these programs may be an effective strategy for addressing this barrier and mitigating accelerated summer BMI gain but requires further investigation on the optimal dose - the minimum exposure needed to see meaningful results while not overextending resources.

Methods

This study will use a multi-arm randomized controlled trial with three treatment levels. Children (n = 360) ages 5–12 years from participating schools (n = 4) will be randomly assigned to either summer as usual (comparison group) or to receive a voucher to attend an existing summer day camp for 4-, 6-, or 8-, weeks. BMI will be objectively measured at baseline (i.e., ∼May), 3-months (i.e., ∼August), and 12-months (i.e., ∼May of following school year). Obesogenic behaviors (e.g., physical activity, diet, screen time, and sleep) will be assessed in spring (i.e., late May) and summer (i.e., late June and July). Implementation factors, such as content, attendance frequency, duration, and coverage, relationship with children's summer BMI gain and obesogenic behaviors will also be evaluated. The study will also evaluate the cost-effectiveness of each duration.

Discussion

The study's findings will identify the optimal dose of summer programming to mitigate excess summer BMI gain, informing effective public health initiatives to combat childhood obesity.

Trial Registration: NCT06158594

https://clinicaltrials.gov/study/NCT06158594?titles=determining%20optimal%20amount%20of%20structured%20environments&rank=1.

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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.