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

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

Abstract

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.