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The Effect of Re-randomization in a Smoking Cessation Trial.

Park E, Choi SH, Duffy SA. The Effect of Re-randomization in a Smoking Cessation Trial. American Journal of Health Behavior. 2016 Sep 1; 40(5):667-74.

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Abstract:

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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