基于移动设备（移动医疗）的学龄前儿童肥胖预防干预的 12 个月随访：MINISTOP 随机对照试验。
A 12-month follow-up of a mobile-based (mHealth) obesity prevention intervention in pre-school children: the MINISTOP randomized controlled trial.
机构信息
Department of Biosciences and Nutrition, Karolinska Institutet, NOVUM, 141 83, Huddinge, Sweden.
Healthy Active Living and Obesity (HALO) Research Group, Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, Ontario, K1H 8L1, Canada.
出版信息
BMC Public Health. 2018 May 24;18(1):658. doi: 10.1186/s12889-018-5569-4.
BACKGROUND
To date, few mobile health (mHealth) interventions aimed at changing lifestyle behaviors have measured long term effectiveness. At the 6-month follow-up the MINISTOP trial found a statistically significant intervention effect for a composite score comprised of fat mass index (FMI) as well as dietary and physical activity variables; however, no intervention effect was observed for FMI. Therefore, the aim of this study was to investigate if the MINISTOP intervention 12-months after baseline measurements: (i) improved FMI and (ii) had a maintained effect on a composite score comprised of FMI and dietary and physical activity variables.
METHODS
A two-arm parallel randomized controlled trial was conducted in 315 healthy 4.5 year old children between January 2014 and October 2015. Parents' of the participating children either received the MINISTOP intervention or a basic pamphlet on dietary and physical activity behaviors (control group). After 6 months, participants did not have access to the intervention content and were measured again 6 months later (i.e. the 12-month follow-up). The Wilcoxon rank-sum test was then used to examine differences between the groups.
RESULTS
At the 12-month follow-up, no statistically significant difference was observed between the intervention and control groups for FMI (p = 0.57) and no maintained effect for the change in composite score was observed (mean ± standard deviation for the intervention and control group: + 0.53 ± 1.49 units and + 0.35 ± 1.27 units respectively, p = 0.25 between groups).
CONCLUSIONS
The intervention effect observed at the 6-month follow-up on the composite score was not maintained at the 12-month follow-up, with no effect on FMI being observed at either follow-up. Future studies using mHealth are needed to investigate how changes in obesity related markers in young children can be maintained over longer time periods.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT02021786 ; 20 Dec 2013).
背景
迄今为止，很少有针对改变生活方式行为的移动健康（mHealth）干预措施能够衡量长期效果。MINISTOP 试验在 6 个月随访时发现，由脂肪质量指数（FMI）以及饮食和体力活动变量组成的综合评分存在统计学上的干预效果；然而，FMI 并未观察到干预效果。因此，本研究旨在探讨 MINISTOP 干预措施在基线测量后 12 个月是否：（i）改善了 FMI；（ii）对由 FMI 和饮食及体力活动变量组成的综合评分保持干预效果。
方法
2014 年 1 月至 2015 年 10 月，在 315 名 4.5 岁健康儿童中进行了一项双臂平行随机对照试验。参与儿童的家长要么接受 MINISTOP 干预，要么接受关于饮食和体力活动行为的基本小册子（对照组）。6 个月后，参与者无法获取干预内容，6 个月后再次测量（即 12 个月随访）。然后使用 Wilcoxon 秩和检验比较两组之间的差异。
结果
在 12 个月随访时，FMI 组间无统计学显著差异（p=0.57），也未观察到复合评分变化的维持效应（干预组和对照组的平均值±标准差分别为+0.53±1.49 单位和+0.35±1.27 单位，p=0.25）。
结论
在 6 个月随访时观察到的复合评分的干预效果在 12 个月随访时没有维持，在两个随访中均未观察到 FMI 的影响。需要使用 mHealth 进行未来研究，以探讨如何在更长时间内维持幼儿肥胖相关标志物的变化。
试验注册
ClinicalTrials.gov（NCT02021786；2013 年 12 月 20 日）。
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