Evaluation of a cluster-randomized controlled trial: Communities for Healthy Living, family-centered obesity prevention program for Head Start parents and children.
Evaluation of a cluster-randomized controlled trial: Communities for Healthy Living, family-centered obesity prevention program for Head Start parents and children.
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DOI：
10.1186/s12966-022-01400-2
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发表时间：
2023-01-11
影响因子：
8.7
通讯作者：
Davison, Kirsten K. K.
中科院分区：
文献类型：
--
作者：
Gago, Cristina;Aftosmes-Tobio, Alyssa;Beckerman-Hsu, Jacob P. P.;Oddleifson, Carly;Garcia, Evelin A. A.;Lansburg, Kindra;Figueroa, Roger;Yu, Xinting;Kitos, Nicole;Torrico, Merieka;Leonard, Jessie;Jurkowski, Janine K. K.;Mattei, Josiemer;Kenney, Erica L. L.;Haneuse, Sebastien;Davison, Kirsten K. K.
关键词：
本研究报告了健康生活社区 (CHL) 的结果，这是一项与 Head Start 合作实施的整群随机肥胖预防试验，Head Start 是一个联邦资助的针对低收入家庭的学前项目。使用阶梯楔形设计，Head Start 计划（n = 16；美国马萨诸塞州波士顿）被随机分配到三个干预开始时间之一。 CHL 参与了媒体宣传活动并加强了营养支持。家长受邀参加家长健康生活连线 (PConnect)，这是一项为期 10 周的健康计划。在每个学年（2017-2019）开始和结束时，收集关于儿童体重指数 z 得分（BMIz）和修正后 BMIz 的主要结果的数据，以及儿童体重相关行为（饮食、体力活动、睡眠、媒体使用）以及父母与体重相关的育儿实践和赋权的次要结果的数据。由于 COVID-19 大流行，我们使用了 2 年（而不是 3 年）的数据来评估 CHL。我们使用混合效应线性回归来比较干预期与对照期（n = 1274 名儿童与 2476 名儿童）在以下方面的相对差异：(1) 儿童 BMIz 和修正后 BMIz 的平均变化，(2) 满足儿童健康行为建议的几率，(3) 养育方式的平均变化，以及 (4) 父母赋权的平均变化。我们还比较了选择随机分组后参与 PConnect 与不参与 PConnect 的家长的结果（n = 55 与 443）。在干预期间（与对照组相比），儿童的 BMIz 和修正后的 BMIz 增加幅度更大（b = 0.06，95% CI = 0.02,0.10；b = 0.07，95% CI = 0.03, 0.12），但更有可能满足与八个测量行为中的三个相关的建议：含糖饮料消耗量（即很少饮用；比值比 (OR) = 1.5，95% CI = 1.2,2.3）、饮水量（即每天多次；OR = 1.6，95% CI = 1.2,2.3）和屏幕时间（即， ≤1 小时/天；OR = 1.4，95% CI = 1.0,1.8)。在父母赋权或育儿实践中，干预（与对照）期间没有观察到显着差异。然而，参加 PConnect 的家长（与未参加 PConnect 的家长相比）表现出更大的赋权增加（b = 0.17，95% CI = 0.04,0.31）。强调家长参与的干预措施可能会增强家长的赋权。干预暴露与 BMIz 的显着增加以及符合三种儿童行为建议的几率增加有关，但在临床上却没有统计学意义；提前暂停试验可能可以解释不同的结果。 ClinicalTrials.gov，NCT03334669，2017 年 10 月注册。在线版本包含可在 10.1186/s12966-022-01400-2 获取的补充材料。
This study reports the outcomes of Communities for Healthy Living (CHL), a cluster randomized obesity prevention trial implemented in partnership with Head Start, a federally-funded preschool program for low-income families. Using a stepped wedge design, Head Start programs (n = 16; Boston, MA, USA) were randomly assigned to one of three intervention start times. CHL involved a media campaign and enhanced nutrition support. Parents were invited to join Parents Connect for Healthy Living (PConnect), a 10-week wellness program. At the beginning and end of each school year (2017-2019), data were collected on the primary outcome of child Body Mass Index z-score (BMIz) and modified BMIz, and secondary outcomes of child weight-related behaviors (diet, physical activity, sleep, media use) and parents’ weight-related parenting practices and empowerment. Data from 2 years, rather than three, were utilized to evaluate CHL due to the COVID-19 pandemic. We used mixed effects linear regression to compare relative differences during intervention vs. control periods (n = 1274 vs. 2476 children) in (1) mean change in child BMIz and modified BMIz, (2) the odds of meeting child health behavior recommendations, (3) mean change in parenting practices, and (4) mean change in parent empowerment. We also compared outcomes among parents who chose post-randomization to participate in PConnect vs. not (n = 55 vs. 443). During intervention periods (vs. control), children experienced greater increases in BMIz and modified BMIz (b = 0.06, 95% CI = 0.02,0.10; b = 0.07, 95% CI = 0.03, 0.12), yet were more likely to meet recommendations related to three of eight measured behaviors: sugar-sweetened beverage consumption (i.e., rarely consume; Odds Ratio (OR) = 1.5, 95% CI = 1.2,2.3), water consumption (i.e., multiple times per day; OR = 1.6, 95% CI = 1.2,2.3), and screen time (i.e., ≤1 hour/day; OR = 1.4, 95% CI = 1.0,1.8). No statistically significant differences for intervention (vs. control) periods were observed in parent empowerment or parenting practices. However, parents who enrolled in PConnect (vs. not) demonstrated greater increases in empowerment (b = 0.17, 95% CI = 0.04,0.31). Interventions that emphasize parent engagement may increase parental empowerment. Intervention exposure was associated with statistically, but not clinically, significant increases in BMIz and increased odds of meeting recommendations for three child behaviors; premature trial suspension may explain mixed results. ClinicalTrials.gov, NCT03334669, Registered October 2017. The online version contains supplementary material available at 10.1186/s12966-022-01400-2.
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