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Effects on engagement and health literacy outcomes of web-based materials promoting physical activity in people with diabetes: an international randomized trial
Muller I, Rowsell A, Stuart B, Hayter V, Little P, Ganahl K, Muller G, Doyle G, Chang P, Lyles CR, Nutbeam D, Yardley L
Journal of Medical Internet Research 2017 Jan;19(1):e21
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Developing accessible web-based materials to support diabetes self-management in people with lower levels of health literacy is a continuing challenge. OBJECTIVE: The objective of this international study was to develop a web-based intervention promoting physical activity among people with type 2 diabetes to determine whether audiovisual presentation and interactivity (quizzes, planners, tailoring) could help to overcome the digital divide by making digital interventions accessible and effective for people with all levels of health literacy. This study also aimed to determine whether these materials can improve health literacy outcomes for people with lower levels of health literacy and also be effective for people with higher levels of health literacy. METHODS: To assess the impact of interactivity and audiovisual features on usage, engagement, and health literacy outcomes, we designed two versions of a web-based intervention (one interactive and one plain-text version of the same content) to promote physical activity in people with type 2 diabetes. We randomly assigned participants from the United Kingdom, Austria, Germany, Ireland, and Taiwan to either an interactive or plain-text version of the intervention in English, German, or Mandarin. Intervention usage was objectively recorded by the intervention software. Self-report measures were taken at baseline and follow-up (immediately after participants viewed the intervention) and included measures of health literacy, engagement (website satisfaction and willingness to recommend the intervention to others), and health literacy outcomes (diabetes knowledge, enablement, attitude, perceived behavioral control, and intention to undertake physical activity). RESULTS: In total, 1,041 people took part in this study. Of the 1,005 who completed health literacy information, 268 (26.67%) had intermediate or low levels of health literacy. The interactive intervention overall did not produce better outcomes than did the plain-text version. Participants in the plain-text intervention group looked at significantly more sections of the intervention (mean difference -0.47, 95% CI -0.64 to -0.30, p < 0.001), but this did not lead to better outcomes. Health literacy outcomes, including attitudes and intentions to engage in physical activity, significantly improved following the intervention for participants in both intervention groups. These improvements were similar across higher and lower health literacy levels and in all countries. Participants in the interactive intervention group had acquired more diabetes knowledge (mean difference 0.80, 95% CI 0.65 to 0.94, p < 0.001). Participants from both groups reported high levels of website satisfaction and would recommend the website to others. CONCLUSIONS: Following established practice for simple, clear design and presentation and using a person-based approach to intervention development, with in-depth iterative feedback from users, may be more important than interactivity and audiovisual presentations when developing accessible digital health interventions to improve health literacy outcomes. CLINICAL TRIAL: International Standard Randomized Controlled Trial Number (ISRCTN) ISRCTN43587048; http://www.isrctn.com/ISRCTN43587048.

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