• BMJ open · May 2019

    Randomized Controlled Trial

    Accounting for health literacy and intervention preferences when reducing unhealthy snacking: protocol for an online randomised controlled trial.

    • Julie Ayre, Erin Cvejic, Carissa Bonner, Robin M Turner, Stephen D Walter, and Kirsten J McCaffery.
    • Faculty of Medicine and Health, Sydney School of Public Health, Sydney Health Literacy Lab, The University of Sydney, Sydney, New South Wales, Australia.
    • BMJ Open. 2019 May 28; 9 (5): e028544.

    IntroductionHealth literacy describes the cognitive and social skills that individuals use to access, understand and act on health information. Health literacy interventions typically take the 'universal precautions approach' where all consumers are presented with simplified materials. Although this approach can improve knowledge and comprehension, its impact on complex behaviours is less clear. Systematic reviews also suggest that health literacy interventions underuse volitional strategies (such as planning) that play an important role in behaviour change. A recent study found volitional strategies may need to be tailored to the participant's health literacy. The current study aims to replicate these findings in a sample of people who have diabetes and/or are overweight or obese as measured by body mass index, and to investigate the most effective method of allocating an action plan to a participant to reduce unhealthy snacking.Methods And AnalysisWe plan to recruit approximately 2400 participants at baseline. Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking ('standard' action plan or 'literacy-sensitive' action plan). Participants will be randomised to a method of allocation to an action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection. Primary outcome is self-reported serves of unhealthy snacks during the previous month. Multiple linear regression will evaluate the impact of health literacy on intervention effectiveness. The analysis will also identify independent contributions of each action plan, method of allocation, health literacy and participant selections on unhealthy snacking at 4-week follow-up.Ethics And DisseminationThis study was approved by the University of Sydney Human Research Ethics Committee (2017/793). Findings will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies (Diabetes New South Wales (NSW) & Australian Capital Territory (ACT), and Western Sydney Local Health District).Trial Registration NumberACTRN12618001409268; Pre-results.© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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