Contemporary Clinical Trials Communications (Jun 2023)
An integrated approach to address diabetes in the context of food insecurity: Delivering health study protocol
Abstract
Background: Diabetes self-management education and support (DSMES) interventions among food insecure individuals with type 2 diabetes (T2D) have found modest improvements in nutrition and health outcomes but are limited by barriers to attendance and retention. This study applies a community-based participatory research approach, engaging community members at all levels of intervention planning, development, implementation, and dissemination, to deliver a plain-language DSMES curriculum to food insecure community members with T2D. Methods: This is a single-arm, pre-post design assessing the efficacy of a 12-week home-delivered DSMES curriculum and T2D-appropriate food box intervention to improve the nutrition and health outcomes of food insecure individuals with T2D. The intervention consists of a weekly food box delivery and handout with video links on key DSMES topics, developed and refined using community advisor feedback. Up to 100 English-, Spanish-, or Marshallese-speaking adult participants with T2D (HbA1c ≥ 7%) and food insecurity are being recruited from food pantries in northwest Arkansas. Data is collected at pre-intervention and immediately post-intervention. The primary study outcome is change in HbA1c. Secondary measures include diet quality (Healthy Eating Index-2015, calculated from 3 24-h dietary recall interviews via phone), body mass index, blood pressure, skin carotenoids, food security, T2D self-management behaviors, T2D self-efficacy, and T2D-related distress. Results: Recruitment began in August 2021 and enrollment is anticipated to be complete in March 2023. Conclusion: Findings from this study will provide a rich understanding of diabetes-related health outcomes and dietary patterns of individuals with food insecurity and T2D and inform future food-focused DSMES interventions in this setting.
