A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial,The Lancet Diabetes & Endocrinology

当前位置： X-MOL 学术 › Lancet Diabetes Endocrinol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

A community-based, multi-level, multi-setting, multi-component intervention to reduce weight gain among low socioeconomic status Latinx children with overweight or obesity: The Stanford GOALS randomised controlled trial
The Lancet Diabetes & Endocrinology ( IF 44.5 ) Pub Date : 2021-04-29 , DOI: 10.1016/s2213-8587(21)00084-x
Thomas N Robinson ₁ , Donna Matheson ₂ , Darrell M Wilson ₃ , Dana L Weintraub ₂ , Jorge A Banda ₄ , Arianna McClain ₅ , Lee M Sanders ₆ , William L Haskell ₇ , K Farish Haydel ₂ , Kristopher I Kapphahn ₈ , Charlotte Pratt ₉ , Kimberly P Truesdale ₁₀ , June Stevens ₁₁ , Manisha Desai ₁₂

Affiliation

Stanford Solutions Science Lab, Department of Pediatrics, Stanford University, Stanford, CA, USA; Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA; Prevention Research Center, Stanford University, Stanford, CA, USA; Department of Medicine, Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA.
Stanford Solutions Science Lab, Department of Pediatrics, Stanford University, Stanford, CA, USA; Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA.
Division of Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA.
Department of Public Health, Purdue University, West Lafayette, Indiana, USA.
Cruise, LLC San Francisco, CA, USA.
Division of General Pediatrics, Department of Pediatrics, Stanford University, Stanford, CA, USA.
Prevention Research Center, Stanford University, Stanford, CA, USA.
Quantitative Sciences Unit, Stanford University, Stanford, CA, USA.
Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, MA, USA.
Department of Nutrition, University of Carolina, Chapel Hill, NC, USA.
Department of Nutrition, University of Carolina, Chapel Hill, NC, USA; Department of Epidemiology, University of Carolina, Chapel Hill, NC, USA.
Quantitative Sciences Unit, Stanford University, Stanford, CA, USA; Department of Medicine, Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA; Department of Biomedical Data Science, Stanford University, Stanford, CA, USA.

Background

There are few long-term studies of interventions to reduce in low socioeconomic status children with overweight or obesity. The Stanford GOALS trial evaluated a 3-year, community-based, multi-level, multi-setting, multi-component (MMM) systems intervention, to reduce weight gain among low socioeconomic status, Latinx children with overweight or obesity.

Methods

We did a two-arm, parallel group, randomised, open-label, active placebo-controlled trial with masked assessment over 3 years. Families from low-income, primarily Latinx communities in Northern California, CA, USA, with 7–11-year-old children with overweight or obesity were randomly assigned to a MMM intervention or a Health Education (HE) comparison intervention. The MMM intervention included home environment changes and behavioural counselling, community after school team sports, and reports to primary health-care providers. The primary outcome was child BMI trajectory over three years. Secondary outcomes included one- and two-year changes in BMI. This trial is registered with ClinicalTrials.gov NCT01642836.

Findings

Between July 13, 2012, and Oct 3, 2013, 241 families were recruited and randomly assigned to MMM (n=120) or HE (n=121). Children's mean age was 9·5 (SD 1·4) years, 134 (56%) were female and 107 (44%) were male, and 236 (98%) were Latinx. 238 (99%) children participated in year 1, 233 (97%) in year 2, and 227 (94%) in year 3 of follow-up assessments. In intention-to-treat analysis, over 3 years, the difference between intervention groups in BMI trajectory was not significant (mean adjusted difference −0·25 [95% CI −0·90 to 0·40] kg/m²; Cohen's d=0.10; p=0·45). Children in the MMM intervention group gained less BMI over 1 year than did children in the HE intervention group (−0·73 [–1·07 to −0·39] kg/m², d=0.55); the same was true over 2 years (−0·63 [–1·13 to −0·14] kg/m²; d =0.33). No differential adverse events were observed.

Interpretation

The MMM intervention did not reduce BMI gain versus HE over 3 years but the effects over 1 and 2 years in this rigorous trial show the promise of this systems intervention approach for reducing weight gain and cardiometabolic risk factors in low socioeconomic status communities.

Funding

US National Institutes of Health.

中文翻译：

一项基于社区、多层次、多环境、多成分的干预措施，以减少社会经济地位低的拉丁裔超重或肥胖儿童的体重增加：斯坦福目标随机对照试验

背景

很少有关于干预措施以减少超重或肥胖的低社会经济地位儿童的长期研究。斯坦福 GOALS 试验评估了一项为期 3 年、以社区为基础、多层次、多环境、多成分 (MMM) 系统干预措施，以减少社会经济地位低下、超重或肥胖的拉丁裔儿童的体重增加。

方法

我们进行了一项为期 3 年的双臂、平行组、随机、开放标签、活性安慰剂对照试验，并进行了隐蔽评估。来自美国加利福尼亚州北加利福尼亚的低收入家庭，主要是拉丁裔社区，有 7-11 岁超重或肥胖儿童的家庭被随机分配到 MMM 干预或健康教育 (HE) 比较干预。MMM 干预包括家庭环境变化和行为咨询、课后社区运动以及向初级卫生保健提供者报告。主要结果是三年内的儿童 BMI 轨迹。次要结果包括 BMI 的一年和两年变化。该试验已在 ClinicalTrials.gov NCT01642836 注册。

发现

在 2012 年 7 月 13 日至 2013 年 10 月 3 日期间，招募了 241 个家庭并随机分配到 MMM (n=120) 或 HE (n=121)。儿童的平均年龄为 9·5 (SD 1·4) 岁，其中 134 名 (56%) 为女性，107 名 (44%) 为男性，236 名 (98%) 为拉丁裔。238 (99%) 名儿童参加了第 1 年的随访评估，233 名 (97%) 参加了第 2 年，227 名 (94%) 参加了第 3 年的随访评估。在意向治疗分析中，超过 3 年，干预组之间 BMI 轨迹的差异不显着（平均调整差异 -0·25 [95% CI -0·90 至 0·40] kg/m ²；Cohen's d=0.10；p=0·45)。MMM 干预组的儿童在 1 年内获得的 BMI 低于 HE 干预组的儿童（-0·73 [–1·07 至 -0·39] kg/m ²，d=0.55）；2 年内也是如此（-0·63 [–1·13 到 -0·14] kg/m ²; d = 0.33)。没有观察到不同的不良事件。