Chi Donald L, Lewis Frances Marcus, Weinstein Philip, Mancl Lloyd, Milgrom Peter, Edwards Todd, Coldwell Susan, O'Brien Diane, Bersamin Andrea, Hopkins Scarlett, Orr Eliza, Rivera Patricia, Lenaker Dane, Sylvetsky Allison, Gittelsohn Joel, Walter Peter, Randall Cameron L, Wiseman Deanna, Dock Andrea, Ko Alice, Orack Joshua, Nemawarkar Deeksha, Panchal Shraddha, Soper Jane, Hill Courtney M, Kerr Darragh, Nguyen Daisy Patiño, Chen Chien-Yu, MacLachlan Ellen
Department of Oral Health Sciences, University of Washington School of Dentistry, 1959 NE Pacific Street, Box 357475, Seattle, WA 98195, USA; Department of Health Systems and Population Health, University of Washington School of Public Health, 3980 15th Ave NE, Fourth Floor, Box 351621, Seattle, WA 98195, USA.
Department of Child, Family and Population Health Nursing, University of Washington School of Nursing, Health Sciences Building, Room T-301, 1959 NE Pacific Street, Seattle, WA, 98195, USA.
Contemp Clin Trials. 2024 Dec;147:107734. doi: 10.1016/j.cct.2024.107734. Epub 2024 Nov 1.
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.
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.
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.
ClinicalTrials.govNCT05219448 (first posted on February 2, 2022).
本研究方案描述了一项基于社区的干预措施，该措施旨在通过减少含糖水果饮料的摄入量，降低阿拉斯加尤皮克族原住民儿童的添加糖摄入量。
将采用两组非随机设计，在阿拉斯加的三个尤皮克族社区对1至12岁以下儿童进行干预评估，最低招募目标为192名儿童。干预组的家庭将参加一个由五节课程加四次简短回访组成的项目，所有课程均由尤皮克族社区卫生工作者提供。将对当地商店环境进行改造，为家庭提供购买无糖水添加剂的场所。延迟治疗对照组的家庭在主要研究期间不接受任何干预。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，以及从每个参与研究的儿童身上采集头发和牙菌斑样本。结果将是基于经过验证的头发生物标志物（每天添加糖的克数），从基线到6个月添加糖摄入量的变化。我们假设，通过头发生物标志物测量，干预组儿童的添加糖摄入量减少幅度将大于对照组儿童。
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来减少阿拉斯加原住民社区的添加糖摄入量。
ClinicalTrials.govNCT05219448（首次发布于2022年2月2日）。
