The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial.
The effectiveness of an online intervention in preventing excessive gestational weight gain: the e-moms roc randomized controlled trial.
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DOI：
10.1186/s12884-018-1767-4
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发表时间：
2018-05-09
影响因子：
3.1
通讯作者：
Fernandez ID
中科院分区：
文献类型：
--
作者：
Olson CM;Groth SW;Graham ML;Reschke JE;Strawderman MS;Fernandez ID
妊娠期体重增加过多（GWG）很常见，会导致女性及其后代肥胖。电子或电子健康干预措施有可能惠及大量女性并防止 GWG 过多，但其有效性尚未得到证实。本研究的目的是在现实环境中评估自我导向、综合在线和手机行为干预在预防过度 GWG 方面的有效性。这项有效性试验是一项双盲、三臂试验，采用平行组设计。两只手臂在怀孕期间接受了相同的电子健康干预，第三只手臂作为安慰剂对照。该干预措施基于先前有效的非数字干预措施，现已适应电子格式。它包括三种行为改变工具：体重增加跟踪器、单独的饮食和身体活动目标设定和自我监控工具。两种治疗条件都可以访问信息工具、事件提醒和博客功能。年龄 18-35 岁、体重指数 (BMI) ≥ 18.5 且 < 35、妊娠 ≤ 20 周且有电子邮件地址的健康孕妇符合资格。根据医学研究所 (IOM) 的定义，总 GWG 过高的女性比例是主要结果。在意向治疗 (ITT) 分析中对 1689 名随机女性进行了分析。该研究设计为具有 87% 的功效，检测到 1641 个样本的控制率比 55% 降低了 10 个百分点（p = 0.0167，双面）。在 ITT 样本中，干预组有 48.1% (SD = 2.0%) 过度增加，安慰剂对照组有 46.2% (SD = 2.4%)。这些比例没有显着差异（RR 1.09；95% CI 0.98, 1.20，p = 0.12）。多项敏感性分析的结果均未改变。在这项在线自我指导干预的有效性试验中，与安慰剂对照相比，在信息安慰剂对照中添加三种行为改变工具并没有导致总 GWG 过高的女性比例出现差异。干预和对照治疗的相似性以及干预组中行为改变工具的低使用率是可能的解释。 NCT01331564，ClinicalTrials.gov。本文的在线版本 (10.1186/s12884-018-1767-4) 包含补充材料，可供授权用户使用。
Excessive gestational weight gain (GWG) is common and contributes to the development of obesity in women and their offspring. Electronic or e-health interventions have the potential to reach large groups of women and prevent excessive GWG, but their effectiveness has not been demonstrated. The purpose of this study was to evaluate, in a real-world setting, the effectiveness of a self-directed, integrated online and mobile phone behavioral intervention in preventing excessive GWG. This effectiveness trial was a double-blind, three-arm trial with a parallel group design. Two arms received the same e-health intervention during pregnancy with the third arm serving as the placebo control. The intervention was based on a previously efficacious non-digital intervention that was adapted to electronic format. It included three behavior change tools: a weight gain tracker, and separate diet and physical activity goal-setting and self-monitoring tools. Both treatment conditions received access to informational tools, event reminders, and a blogging feature. Healthy pregnant women age 18-35 years with body mass indexes (BMI) ≥18.5 and < 35, at ≤20 weeks gestation, and an e-mail address were eligible. The proportion of women with excessive total GWG, as defined by the Institute of Medicine (IOM), was the primary outcome. 1689 randomized women were analyzed in the intent-to-treat (ITT) analysis. The study was designed to have 87% power to detect a 10 percentage point reduction from a control rate of 55% with a sample of 1641 (p = 0.0167, two-sided). In the ITT sample, 48.1% (SD = 2.0%) gained excessively in the intervention group as did 46.2% (SD = 2.4%) in the placebo control group. These proportions were not significantly different (RR 1.09; 95% CI 0.98, 1.20, p = 0.12). The results were not altered in several sensitivity analyses. The addition of three behavior change tools to an informational placebo control did not result in a difference in the proportion of women with excessive total GWG compared to the placebo control in this effectiveness trial of an online, self-directed intervention. The similarity of intervention and control treatments and low usage of the behavior change tools in the intervention group are possible explanations. NCT01331564, ClinicalTrials.gov. The online version of this article (10.1186/s12884-018-1767-4) contains supplementary material, which is available to authorized users.
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影响因子：
9.8
作者：
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通讯作者：
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