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《美属太平洋地区儿童健康生活计划对超重、肥胖和黑棘皮病的维持效果:一项随机临床试验》。

Maintenance Outcomes of the Children's Healthy Living Program on Overweight, Obesity, and Acanthosis Nigricans Among Young Children in the US-Affiliated Pacific Region: A Randomized Clinical Trial.

机构信息

Department of Human Nutrition, Food and Animal Sciences, College of Tropical Agriculture and Human Resources, University of Hawai'i at Mānoa, Honolulu.

Population Sciences in the Pacific Program, University of Hawai'i Cancer Center, Honolulu.

出版信息

JAMA Netw Open. 2022 Jun 1;5(6):e2214802. doi: 10.1001/jamanetworkopen.2022.14802.

Abstract

IMPORTANCE

Few obesity prevention trials among children have demonstrated sustainable outcomes in the long term.

OBJECTIVES

To sustain a community-wide decrease in the prevalence of overweight and obesity among young children in the US-affiliated Pacific region.

DESIGN, SETTING, AND PARTICIPANTS: In the Children's Healthy Living community-randomized clinical trial, hierarchical modeling comparing the change in intervention and control communities accounted for community randomization (community clustering with jurisdictions), and adjusted for the age and sex distribution of the assessed children in a cross-sectional design. The outcome measures were repeated in communities rather than among individual children. A total of 27 communities in 5 jurisdictions (Hawai'i, Alaska, Commonwealth of the Northern Mariana Islands, American Samoa, and Guam) of the US-affiliated Pacific region were included. Participants included children aged 2 to 8 years in the 27 selected communities from October 1, 2012 (4329 in time 1 [baseline]) to August 31, 2015 (4043 in time 2 [intervention end]) and from January 1, 2019, to April 30, 2020 (1469 in time 3 [maintenance period]). Study analysis was completed March 25, 2022.

INTERVENTIONS

Nineteen activities addressed training, policies, systems, and environments of communities and 6 target behaviors of children (consumption of fruit and vegetables, water, and sugar-sweetened beverages; sleep; physical activity; and screen time) during a 2-year intervention period. Continued partnership with community coalitions, ongoing academic training of community partners, and use of trial data during a 6-year maintenance period.

MAIN OUTCOMES AND MEASURES

The primary outcome was measured anthropometry; secondary outcomes were the presence of acanthosis nigricans, dietary intake derived from 2 days of food records, and survey questions on screen time and sleep disturbance.

RESULTS

Among the 9840 children included in the analysis (4866 girls [49.5%] and 4974 boys [50.5%]; 6334 [64.4%] aged 2-5 years), the intervention group showed significant improvements compared with the control group from times 1 to 3 in prevalence of overweight plus obesity (d = -12.60% [95% CI, -20.92% to -4.28%]), waist circumference (d = -1.64 [95% CI, -2.87 to -0.41] cm), and acanthosis nigricans prevalence (d = -3.55% [95% CI, -6.17% to -0.92%]). Significant improvements were also observed from times 2 to 3 in prevalence of overweight plus obesity (d = -8.73% [95% CI, -15.86% to -1.60%]) but not in waist circumference (d = -0.81 [95% CI, -1.85 to 0.23] cm).

CONCLUSIONS AND RELEVANCE

This randomized clinical trial found that the outcomes of the Children's Healthy Living intervention were maintained and enhanced 6 years after the intervention among young children in the US-affiliated Pacific region. The prevalence of overweight, obesity, and acanthosis nigricans was further reduced in communities, suggesting that multilevel multicomponent interventions may help reduce child overweight and obesity in this region.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01881373.

摘要

重要性

在儿童中,很少有肥胖预防试验在长期内显示出可持续的结果。

目的

在美国属地太平洋地区,维持社区内 2 至 8 岁儿童超重和肥胖患病率的持续下降。

设计、地点和参与者:在儿童健康生活社区随机临床试验中,对干预社区和对照社区的变化进行层次建模,考虑到了社区随机化(与司法管辖区的社区聚类),并根据横断面设计中评估儿童的年龄和性别分布进行了调整。在社区而不是在个体儿童中重复进行了这些结果的测量。总共包括来自美国属地太平洋地区 5 个司法管辖区(夏威夷州、阿拉斯加州、北马里亚纳群岛联邦、美属萨摩亚和关岛)的 27 个社区。参与者包括 2012 年 10 月 1 日(时间 1 [基线] 时的 4329 名)至 2015 年 8 月 31 日(时间 2 [干预结束] 时的 4043 名)和 2019 年 1 月 1 日至 2020 年 4 月 30 日(时间 3 [维持期] 时的 1469 名)在 27 个选定社区中年龄在 2 至 8 岁的儿童。研究分析于 2022 年 3 月 25 日完成。

干预措施

19 项活动针对社区的培训、政策、系统和环境以及儿童的 6 项目标行为(食用水果和蔬菜、水和含糖饮料、睡眠、体力活动和屏幕时间)进行了干预,干预时间为 2 年。在 6 年的维持期内继续与社区联盟合作,对社区合作伙伴进行持续的学术培训,并使用试验数据。

主要结果和措施

主要结果是通过人体测量法测量的;次要结果是黑棘皮病的存在、从 2 天的食物记录中得出的饮食摄入以及关于屏幕时间和睡眠障碍的调查问题。

结果

在分析中包括的 9840 名儿童(4866 名女孩[49.5%]和 4974 名男孩[50.5%];6334 名[64.4%]年龄为 2-5 岁)中,与对照组相比,干预组从时间 1 到时间 3 的超重加肥胖患病率(差值=-12.60%[95%CI,-20.92%至-4.28%])、腰围(差值=-1.64[95%CI,-2.87 至-0.41]cm)和黑棘皮病患病率(差值=-3.55%[95%CI,-6.17%至-0.92%])均有显著改善。从时间 2 到时间 3,超重加肥胖患病率(差值=-8.73%[95%CI,-15.86%至-1.60%])也有显著改善,但腰围(差值=-0.81[95%CI,-1.85 至 0.23]cm)则没有。

结论和相关性

这项随机临床试验发现,在美国属地太平洋地区,儿童健康生活干预的结果在干预结束 6 年后仍得以维持和增强。社区中儿童超重、肥胖和黑棘皮病的患病率进一步降低,这表明多层次多成分干预措施可能有助于减少该地区儿童的超重和肥胖。

试验注册

ClinicalTrials.gov 标识符:NCT01881373。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e0e2/9171559/aff5073898c5/jamanetwopen-e2214802-g001.jpg

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