健康饮料，健康牙齿 - Ciunerkaq Tanqigtuq（前途光明）：以社区为基础的非随机社会行为试验研究方案，旨在减少育空-库斯科克维姆三角洲阿拉斯加原住民尤皮克儿童的添加糖摄入量。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2024-11-01 DOI:10.1016/j.cct.2024.107734

Donald L. Chi , Frances Marcus Lewis , Philip Weinstein , Lloyd Mancl , Peter Milgrom , Todd Edwards , Susan Coldwell , Diane O'Brien , Andrea Bersamin , Scarlett Hopkins , Eliza Orr , Patricia Rivera , Dane Lenaker , Allison Sylvetsky , Joel Gittelsohn , Peter Walter , Cameron L. Randall , Deanna Wiseman , Andrea Dock , Alice Ko , Ellen MacLachlan

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引用次数: 0

摘要

背景：本研究方案介绍了一项基于社区的干预措施，旨在通过减少含糖水果饮料的摄入量来减少阿拉斯加原住民尤普艾克儿童的添加糖摄入量：本研究方案介绍了一项以社区为基础的干预措施，旨在通过减少含糖水果饮料的摄入量来减少阿拉斯加原住民尤皮克儿童的添加糖摄入量：将采用两组非随机设计，在阿拉斯加州的三个尤皮伊克社区对干预措施进行评估，重点关注 1 岁至 12 岁以下的儿童，最低招募目标为 192 名儿童。干预组的家庭将参加由五次课程和四次简短的检查组成的计划，所有课程均由一名尤普安克社区保健工作者负责实施。将对当地商店环境进行改造，为家庭提供购买无糖增水剂的场所。延迟治疗对照组的家庭在主要研究期间将不接受任何干预。将进行五次数据收集访问（基线、1 个月、3 个月、6 个月和 12 个月），包括收集调查和饮食数据，以及每个参与儿童的头发和牙菌斑样本。结果将是根据经过验证的头发生物标志物（添加糖的克数/天）计算的添加糖摄入量从基线到 6 个月的变化。我们假设，与对照组的儿童相比，干预组的儿童通过头发生物标志物测量的添加糖摄入量将有更大的减少：讨论：这是已知的首批基于社区的社会行为干预措施之一，旨在通过针对含糖水果饮料，减少阿拉斯加原住民社区的添加糖摄入量：试验注册：ClinicalTrials.govNCT05219448（首次发布于2022年2月2日）。

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Healthy Drinks, Healthy Teeth – Ciunerkaq Tanqigtuq (The Future is Bright): A study protocol for a community-based, non-randomized sociobehavioral trial to reduce added sugar intake in Alaska Native Yup'ik children in the Yukon-Kuskokwim Delta

Background

This study protocol describes a community-based intervention that will seek to reduce added sugar intake in Yup'ik Alaska Native children by targeting reductions in sugar-sweetened fruit drinks.

Methods

A two-group non-randomized design will be used to evaluate the intervention in three Yup'ik communities in Alaska focusing on children age 1 to less than age 12 years with a minimum enrollment target of 192 children. Families in the intervention arm will participate in a program consisting of five sessions plus four brief check-ins, all delivered by a Yup'ik Community Health Worker. Modifications to the local store environment will be made to give families a place to purchase sugar-free water enhancers. Families in the delayed treatment control arm will receive no intervention during the main study period. There will be five data collection visits (baseline, 1-month, 3-months, 6-months, and 12-months) that will include collection of survey and dietary data, and a hair and plaque sample from each participating child. The outcomes will be change, from baseline to 6 months, in added sugar intake based on a validated hair biomarker (grams of added sugar/day). We hypothesize children in the intervention arm will have greater reductions in added sugar intake compared to children in the control arm as measured by the hair biomarker.

Discussion

This is one of the first known community-based sociobehavioral interventions aimed specifically at reducing added sugar intake in Alaska Native communities by targeting sugar-sweetened fruit drinks.

Trial registration

ClinicalTrials.gov NCT05219448 (first posted on February 2, 2022).

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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.