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The Effect of Re-randomization in a Smoking Cessation Trial

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Objectives: The purpose of this sub-study was to determine whether operating engineers (heavy equipment operators) who failed to quit smoking in a randomized controlled trial would benefit from re-exposure to the interventions one year later. Methods: Operating Engineers attending workplace safety training groups during the winters of 2010 to 2012 were randomized by training group to either to the Tobacco Tactics Web-based intervention or the 1-800-QUIT-NOW telephone line. Of the 145 original participants, 41 reappeared in training groups one year later and were re-randomized with their group. Seven-day point prevalence quit rates at 30-days and 6-months post-intervention were analyzed using the chi-square test and Fisher's exact test. Results: At 30-day follow-up, an additional 9.8% (4/41) of repeaters had quit smoking. At 6-month follow-up, 12.2% (5/41) of repeaters had quit smoking. At 30-day follow-up, increased quitting was more common among those re-randomized to the intervention group than among those who received the control treatment, although this was not statistically significant and was no longer true at 6-month follow-up. Conclusions: Because many smokers make multiple attempts to quit smoking, re-enrollment of participants in smoking cessation trials may produce additional quitters.
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Keywords: RANDOMIZED CONTROLLED TRIAL; RE-ENROLLMENT; RE-RANDOMIZATION; SMOKING CESSATION; WEB-BASED INTERVENTION

Document Type: Research Article

Affiliations: 1: Assistant Professor, University at Buffalo, School of Nursing, Buffalo, NY 2: Assistant Professor, Michigan State University, College of Nursing, East Lansing, MI 3: Mildred E. Newton Endowed Chair, Ohio State University, School of Nursing, Columbus, OH;, Email: [email protected]

Publication date: September 1, 2016

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  • The American Journal of Health Behavior seeks to improve the quality of life through multidisciplinary health efforts in fostering a better understanding of the multidimensional nature of both individuals and social systems as they relate to health behaviors.

    The Journal aims to provide a comprehensive understanding of the impact of personal attributes, personality characteristics, behavior patterns, social structure, and processes on health maintenance, health restoration, and health improvement; to disseminate knowledge of holistic, multidisciplinary approaches to designing and implementing effective health programs; and to showcase health behavior analysis skills that have been proven to affect health improvement and recovery.

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