Department of Maternal and Child Health, School of Public Health, Peking University, National Health Commission Key Laboratory of Reproductive Health, Beijing, China.
Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.
JAMA Pediatr. 2022 Jan 1;176(1):e214375. doi: 10.1001/jamapediatrics.2021.4375. Epub 2022 Jan 4.
A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited.
To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children.
DESIGN, SETTING, AND PARTICIPANTS: A cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol. Twenty-four schools were randomly allocated (1:1) to the intervention or the control group, with 1392 eligible children aged 8 to 10 years participating. Data from the intent-to-treat population were analyzed from October 1 to December 31, 2019.
A multifaceted intervention targeted both children (promoting healthy diet and physical activity) and their environment (engaging schools and families to support children's behavioral changes). The intervention was novel in its strengthening of family involvement with the assistance of a smartphone app. The control schools engaged in their usual practices.
The primary outcome was the change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters) from baseline to the end of the trial. Secondary outcomes included changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness. Generalized linear mixed models were used in the analyses.
Among the 1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses. From baseline to the end of the trial, the mean BMI decreased in the intervention group, whereas it increased in the control group; the mean between-group difference in BMI change was -0.46 (95% CI, -0.67 to -0.25; P < .001), which showed no evidence of difference across different regions, sexes, maternal education levels, and primary caregivers (parents vs nonparents). The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group. The intervention also improved other adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure. No adverse events were observed during the intervention.
The multifaceted intervention effectively reduced the mean BMI and obesity prevalence in primary school children across socioeconomically distinct regions in China, suggesting its potential for national scaling.
ClinicalTrials.gov Identifier: NCT03665857.
快速的营养转型导致许多国家儿童肥胖症的患病率上升，但有效的预防干预措施仍然有限。
确定一种新的多方面干预措施在预防小学生肥胖方面的有效性。
设计、设置和参与者：根据预先制定的试验方案，在中国三个社会经济差异明显的地区进行了一项单学年（从 2018 年 9 月 11 日至 2019 年 6 月 30 日）的集群随机临床试验。24 所学校被随机分配（1:1）到干预组或对照组，共有 1392 名 8 至 10 岁的合格儿童参加。2019 年 10 月 1 日至 12 月 31 日对意向治疗人群进行数据分析。
该多方面干预措施既针对儿童（促进健康饮食和体育活动），也针对其环境（让学校和家庭参与支持儿童的行为改变）。该干预措施新颖之处在于它通过智能手机应用程序加强了家庭参与。对照组学校则参与了他们的常规实践。
主要结果是从基线到试验结束时体重指数（BMI；体重以千克为单位，身高以米为单位）的变化。次要结果包括肥胖相关指标（如 BMI 分数、肥胖患病率）、血压、体育活动和饮食行为、肥胖相关知识和身体素质的变化。分析采用广义线性混合模型。
在 1392 名参与者（平均[SD]年龄，9.6[0.4]岁；717 名男孩[51.5%]；平均[SD]BMI，18.6[3.7]）中，有 1362 名（97.8%）有随访数据被纳入分析。从基线到试验结束，干预组的平均 BMI 下降，而对照组的 BMI 上升；组间 BMI 变化的平均差异为-0.46（95%CI，-0.67 至-0.25；P < 0.001），这表明不同地区、性别、母亲教育程度和主要照顾者（父母与非父母）之间没有差异。干预组肥胖患病率较基线下降 27.0%（相对下降），而对照组仅下降 5.6%。该干预措施还改善了其他肥胖相关指标、饮食、久坐和体育活动行为以及肥胖相关知识，但并未改变中高强度体力活动、身体素质或血压。在干预期间未观察到不良事件。
该多方面干预措施在中国社会经济差异明显的地区有效降低了小学生的平均 BMI 和肥胖症患病率，表明其具有在全国范围内推广的潜力。
ClinicalTrials.gov 标识符：NCT03665857。
