five

Primary and secondary outcome measures.

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Figshare2023-03-02 更新2026-04-28 收录
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https://figshare.com/articles/dataset/Primary_and_secondary_outcome_measures_/22204434
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Previous literature has indicated that Black men are twice as likely to develop type 2 diabetes compared to their non-Hispanic White counterparts and are also more likely to have associated complications. Furthermore, Black men have lower access to quality health care, and masculinity norms have been shown to hinder them from seeking the limited care that is available. In this study, we aim to investigate the effect of peer-led diabetes self-management education and long-term ongoing support on glycemic management. The first phase of our study will consist of modification of existing diabetes education content to be more appropriate for the population of interest, Then, in the second phase, we will conduct a randomized controlled trial to test the intervention. Participants randomized to the intervention arm will receive diabetes self-management education, structured diabetes self-management support, and a more flexible ongoing support period. Participants randomized to the control arm will receive diabetes self-management education. Diabetes self-management education will be taught by certified diabetes care and education specialists, while the diabetes self-management support and ongoing support period will be facilitated by fellow Black men with diabetes who will be trained in group facilitation, patient-provider communication strategies, and empowerment techniques. The third phase of this study will consist of post-intervention interviews and dissemination of findings to the academic community. The primary goal of our study is to determine whether long-term peer-led support groups in conjunction with diabetes self-management education are a promising solution to improve self-management behaviors and decrease A1C levels. We will also evaluate the retention of participants throughout the study, which has historically been an issue in clinical studies focused on the Black male population. Finally, the results from this trial will determine whether we can proceed to a fully-powered R01 trial or if other modifications of the intervention are necessary.Trial registration: Registered at ClinicalTrials.gov with an ID of NCT05370781 on May 12, 2022.
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2023-03-02
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