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Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial
BACKGROUND: 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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications Inc.
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411363/ https://www.ncbi.nlm.nih.gov/pubmed/25872754 http://dx.doi.org/10.2196/mhealth.3928 |
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author | Fukuoka, Yoshimi Gay, Caryl Haskell, William Arai, Shoshana Vittinghoff, Eric |
author_facet | Fukuoka, Yoshimi Gay, Caryl Haskell, William Arai, Shoshana Vittinghoff, Eric |
author_sort | Fukuoka, Yoshimi |
collection | PubMed |
description | BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6XFC5wvrP). |
format | Online Article Text |
id | pubmed-4411363 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | JMIR Publications Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-44113632015-05-08 Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial Fukuoka, Yoshimi Gay, Caryl Haskell, William Arai, Shoshana Vittinghoff, Eric JMIR Mhealth Uhealth Original Paper BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6XFC5wvrP). JMIR Publications Inc. 2015-04-13 /pmc/articles/PMC4411363/ /pubmed/25872754 http://dx.doi.org/10.2196/mhealth.3928 Text en ©Yoshimi Fukuoka, Caryl Gay, William Haskell, Shoshana Arai, Eric Vittinghoff. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 13.04.2015. http://creativecommons.org/licenses/by/2.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mhealth and uhealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Fukuoka, Yoshimi Gay, Caryl Haskell, William Arai, Shoshana Vittinghoff, Eric Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title | Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title_full | Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title_fullStr | Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title_full_unstemmed | Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title_short | Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial |
title_sort | identifying factors associated with dropout during prerandomization run-in period from an mhealth physical activity education study: the mped trial |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4411363/ https://www.ncbi.nlm.nih.gov/pubmed/25872754 http://dx.doi.org/10.2196/mhealth.3928 |
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