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
{"title":"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。","authors":"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","doi":"10.1016/j.cct.2024.107734","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05219448</span><svg><path></path></svg></span> (first posted on February 2, 2022).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":null,"pages":null},"PeriodicalIF":2.0000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/j.cct.2024.107734\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT05219448</span><svg><path></path></svg></span> (first posted on February 2, 2022).</div></div>\",\"PeriodicalId\":10636,\"journal\":{\"name\":\"Contemporary clinical trials\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary clinical trials\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1551714424003173\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714424003173","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
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.govNCT05219448 (first posted on February 2, 2022).
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.