Journal
AMERICAN JOURNAL OF PREVENTIVE MEDICINE
Volume 61, Issue 4, Pages 606-617Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.amepre.2021.04.005
Keywords
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Funding
- NIH [P01 AT00501, K24AT007827, K01AT004199, R01DK103944, R01 HL128666, R01 HD073572, R03 DK113325]
- National Center for Advancing Transla-tional Sciences
- University of California, San Francisco-Clinical and Translational Science Institute [UL1 TR000004]
- Stanford Cancer Institute Cancer Innovation Award
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The study implemented the Methods-Motivational Interviewing approach to enhance participant engagement in randomized trials, achieving higher retention rates and attendance at intervention sessions across three weight-management trials. The results suggest the potential for improving trial rigor through the use of prerequisite orientations and motivational interviewing.
Introduction: Suboptimal and differential participant engagement in randomized trials-includ-ing retention at primary outcome assessments and attendance at intervention sessions-under-mines rigor, internal validity, and trial conclusions. Methods: First, this study describes Methods-Motivational Interviewing approach and strategies for implementation. This approach engages potential participants before randomization through interactive, prerequisite orientation sessions that illustrate the scientific rationale behind trial methods in accessible language and use motivational interviewing to diffuse ambivalence about participation. Then, this study examines the potential improvements in retention (proportion of participants assessed at follow-up visits) and attendance (e.g., mean percentage of intervention sessions attended, percentage of participants who attended 0 sessions) in 3 randomized weight-management trials that quickly added prerequisite orientations to their protocols following early signs of suboptimal or differential participant engagement (Supporting Health by Integrating Nutrition and Exercise [2009-2013, n=194]; Get Social [2016-2020, n=217]; GestationaL Weight Gain and Optimal Wellness [2014-2018, n=389]). Using a pre-post analytical design, adjusted estimates from regression models controlling for condition and assessment timepoint (analyses from 2020) are reported. Results: After adding prerequisite orientations, all 3 trials attained higher participant engagement. Retention at assessments was 11.4% and 17.3% higher (Get Social and Supporting Health by Integrating Nutrition and Exercise, respectively). Mean percentage of attendance at intervention sessions was 8.8% higher (GestationaL Weight Gain and Optimal Wellness), and 10.1% fewer participants attended 0 intervention sessions (Get Social). Descriptively, all the remaining retention and attendance outcomes were consistently higher but were nonsignificant. Across the trials, adding prerequisite orientations did not impact the proportion of eligible participants enrolled or the baseline demographics. Conclusions: The Methods-Motivational Interviewing approach shows promise for increasing the rigor of randomized trials and is readily adaptable to in-person, webinar, and conference call formats. (C) 2021 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.
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