Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial.
Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial.
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DOI：
10.2196/mhealth.3928
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发表时间：
2015-04-13
影响因子：
5
通讯作者：
Vittinghoff E
中科院分区：
文献类型：
--
作者：
Fukuoka Y;Gay C;Haskell W;Arai S;Vittinghoff E
基于移动的手机的体育活动教育（mPED）试验是一项随机对照试验（RCT），旨在评估女性通过移动的手机进行的体育活动干预。该研究包括一个磨合期，以最大限度地提高干预试验的内部效度，但很少有人知道成功的磨合完成相关的因素，从而对外部效度的潜在威胁。本研究的目的是（1）确定导入期脱落的时间、脱落原因、最佳导入持续时间和相关导入组件，以及（2）确定无法完成导入期的预测因素。共有318名身体不活跃的妇女符合初步资格标准，并在2011年5月至2014年4月期间参加了这项研究。随机化前需要3周导入期，包括使用移动的手机应用程序和佩戴计步器。横断面分析确定了辍学的预测因素。在318名参与者中，108名（34.0%）在随机化前退出，使用研究设备的依从性差是最常见的原因。导入期的中位失效时间为17天。在单变量分析中，非随机化参与者更年轻，收入更低，不太可能经常开车，在研究之前不太可能使用计步器，通常不太健康，对身体活动的自我效能感较低，并且报告了比随机化参与者更多的抑郁症状。在多变量竞争风险模型中，在过去一个月内不经常驾驶和在研究之前没有使用计步器与随机化失败显著相关（分别为P= 0.04和0.006），控制年龄，种族/民族，教育，轮班工作和使用研究提供的移动的电话。定期驾驶和过去使用计步器与随机化前导入期脱落率降低相关。了解这些特征对于识别高风险参与者非常重要，实施额外的帮助策略可能有助于减少辍学。ClinicalTrials.gov NCT 01280812; https://clinicaltrials.gov/ct2/show/NCT01280812（由WebCite存档，网址为http：//www.webcitation.org/6XFC5wvrP）。
The mobile phone-based physical activity education (mPED) trial is a randomized controlled trial (RCT) evaluating a mobile phone-delivered physical activity intervention for women. The study includes a run-in period to maximize the internal validity of the intervention trial, but little is known about factors related to successful run-in completion, and thus about potential threats to external validity. Objectives of this study are (1) to determine the timing of dropout during the run-in period, reasons for dropout, optimum run-in duration, and relevant run-in components, and (2) to identify predictors of failure to complete the run-in period. A total of 318 physically inactive women met preliminary eligibility criteria and were enrolled in the study between May 2011 and April 2014. A 3-week run-in period was required prior to randomization and included using a mobile phone app and wearing a pedometer. Cross-sectional analysis identified predictors of dropout. Out of 318 participants, 108 (34.0%) dropped out prior to randomization, with poor adherence using the study equipment being the most common reason. Median failure time was 17 days into the run-in period. In univariate analyses, nonrandomized participants were younger, had lower income, were less likely to drive regularly, were less likely to have used a pedometer prior to the study, were generally less healthy, had less self-efficacy for physical activity, and reported more depressive symptoms than randomized participants. In multivariate competing risks models, not driving regularly in the past month and not having used a pedometer prior to the study were significantly associated with failure to be randomized (P=.04 and .006, respectively), controlling for age, race/ethnicity, education, shift work, and use of a study-provided mobile phone. Regular driving and past pedometer use were associated with reduced dropout during the prerandomization run-in period. Understanding these characteristics is important for identifying higher-risk participants, and implementing additional help strategies may be useful for reducing dropout. ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6XFC5wvrP).
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DOI：
10.1046/j.1532-5415.2003.51465.x
发表时间：
2003-10-01
影响因子：
6.3
作者：
Borson, S;Scanlan, JM;Ganguli, M
通讯作者：
Ganguli, M
影响因子：
3.8
作者：
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DOI：
10.1186/1479-5868-8-115
发表时间：
2011-10-21
期刊：
The international journal of behavioral nutrition and physical activity
影响因子：
--
作者：
Lee PH;Macfarlane DJ;Lam TH;Stewart SM
通讯作者：
Stewart SM
影响因子：
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作者：
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