School of Medicine, Oregon Health and Science University, 3303 SW Bond Avenue CH16D, Portland, OR, 97239, USA.
School of Public Health, Oregon Health and Science University and Portland State University, 3181 SW Sam Jackson Park Road GH230, Portland, OR, 97239, USA.
Trials. 2019 Apr 25;20(1):235. doi: 10.1186/s13063-019-3342-3.
Latino children in the US experience high rates of obesity, increasing their risk of subsequent diabetes. There are few clinical trials among low-income, Latino families to test interventions that account for and address their unique situation.
METHODS/DESIGN: This trial, conducted in a Head Start (early childhood education) setting, randomly assigns children 2-5 years of age who have obesity by CDC (Centers for Disease Control and Prevention) guidelines (at least 95th percentile body mass index) and their parents to one of three conditions: (1) control, (2) parent mentor with an experimental curriculum, or (3) parent mentor with a standard curriculum (active control). We designed the experimental arm (2) using data from positive deviants: low-income, Latino families who had been successful in moving their child toward a healthy weight. Parent mentors are recruited and trained from the Head Start centers. Parent mentors then facilitate the teaching and coaching of parent-child dyads with weekly interactions over the course of a 6-month period. The primary outcome is change in adjusted body mass index z-score at the end of intervention and at 6 months post-intervention. Secondary outcomes include generalized self-efficacy, dietary intake, the home food environment, and reported physical activity.
This clinical trial contributes to the field by evaluating parent mentoring interventions that are potentially scalable for a population at high risk for continued obesity and subsequent morbidity and mortality.
This trial was registered on October 31, 2017 (ClinicalTrials.gov identifier: NCT03330743 ).
美国的拉丁裔儿童肥胖率很高,这增加了他们日后患糖尿病的风险。在低收入的拉丁裔家庭中,针对能够考虑并解决其独特情况的干预措施进行的临床试验很少。
方法/设计:这项试验是在“Head Start”(儿童早期教育)环境中进行的,按照美国疾病控制与预防中心(Centers for Disease Control and Prevention,CDC)的指南(至少第 95 个百分位数的体重指数),将肥胖的 2-5 岁儿童及其父母随机分配到以下三种情况之一:(1)对照组,(2)有实验课程的家长导师组,或(3)有标准课程(主动对照组)的家长导师组。我们使用正离差(positive deviation)数据设计了实验组(2):这些数据来自成功帮助孩子达到健康体重的低收入、拉丁裔家庭。家长导师是从“Head Start”中心招募和培训的。家长导师随后通过每周互动,在 6 个月的时间里促进家长-儿童二人组的教学和辅导。主要结局是干预结束时和干预后 6 个月时调整后的体重指数 z 分数的变化。次要结局包括一般自我效能感、饮食摄入、家庭食物环境和报告的体力活动。
这项临床试验通过评估可能针对肥胖持续和随后发病率和死亡率风险较高的人群进行扩展的家长指导干预措施,为该领域做出了贡献。
这项试验于 2017 年 10 月 31 日注册(ClinicalTrials.gov 标识符:NCT03330743)。