Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes self-management education and support (DSMES) programs have struggled to deliver sustainable, effective support for adults with diabetes (AWDs) to improve self-management behaviors, achieve glycemic goals, and reduce risk for complications. One largely untapped resource for this support is AWDs' social networks. Fifty to 75% of AWDs have an unpaid family member or friend ("support person") who provides ongoing help with diabetes management. However, DSMES interventions to date lack structured and effective approaches to directly engage support persons in AWDs' diabetes management. METHODS: This parallel arm randomized trial is designed to determine the effectiveness of Family Support for Health Action (FAM-ACT), a novel community health worker (CHW)-delivered program focused on educating and supporting patients with type 2 diabetes (T2D) and their support persons (SPs), relative to an established, CHW-delivered, individual patient-focused DSMES and care management (I-DSMES) intervention. Both interventions were developed using a community-based participatory research (CBPR) approach. The study will be conducted in partnership with an urban Federally Qualified Health Center (FQHC) serving a low-income, Latino/a community, with target enrollment of 268 dyads consisting of an FQHC patient with T2D with high HbA1c and an SP. Patient-SP dyads will be randomized to receive FAM-ACT or I-DSMES over 6 months. The primary outcome is change in patient HbA1c from baseline to 6 months. Secondary patient outcomes include 12-month change in HbA1c, changes in patient blood pressure, diabetes self-management behaviors, diabetes distress, patient activation, diabetes self-efficacy, and perceptions of and satisfaction with SP support for diabetes. Secondary SP outcomes include self-efficacy for helping the patient with diabetes management and SP distress about the patient's diabetes. We also will assess the effect of the COVID-19 pandemic on patient's ability to manage diabetes. DISCUSSION: This study will inform scalable, evidence-based approaches that leverage family support to help AWDs improve and sustain self-management strategies that underpin optimal management of multiple diabetes complication risk factors. The protocol is designed for and evaluated with a low-income and predominantly Latino/a community, which may increase applicability to other similar communities. The COVID-19 pandemic presented several challenges to study protocol and intervention delivery; modifications made to address these challenges are described. TRIAL REGISTRATION: ClinicalTrials.gov NCT03812614. Registered on 18 January 2019.

Participation in a farmers' market fruit and vegetable prescription program at a federally qualified health center improves hemoglobin A1C in low income uncontrolled diabetics.

Fruit and vegetable prescription programs have been shown to increase consumption of fresh produce, but whether they have an impact on medical outcomes is unknown. The purpose of this study was to examine the role of participation in a farmers' market and fruit and vegetable prescription program on changes in hemoglobin A1C (HbA1C), blood pressure (BP) and weight in patients with uncontrolled type 2 diabetes at a federally qualified health center (FQHC) in Detroit, MI. The 13-week Fresh Prescription program (June 2015-October 2015) was designed to improve access and consumption of produce among low-income patients with uncontrolled type 2 diabetes. The program allotted up to $40 ($10 per week for up to four weeks) for purchase of produce from a FQHC located farmers' market. Adult, non-pregnant patients with a history of type 2 diabetes that had an elevated HbA1C > 6.5 within three months before Fresh Prescription program were eligible to participate. HgA1c, BP and weight were collected within three months of program start and within three months of completion. There were 65 eligible participants with complete biometric data. A statistically significant (p = 0.001) decrease in HbA1C was found (9.54% to 8.83%). However, weight (208.3 lbs. to 209.0 lbs.) and BP (135.1/79.3 mm Hg to 135.8/77.6 mm Hg) did not change from pre- to post-study (p > 0.05). Access to a fruit and vegetable prescription program over a 13-week period led to decreased HbA1C concentrations in uncontrolled type 2 diabetic patients living in an urban area of predominately-lower socioeconomic status.

Community-based participatory research and user-centered design in a diabetes medication information and decision tool.

BACKGROUND: Together, community-based participatory research (CBPR), user-centered design (UCD), and health information technology (HIT) offer promising approaches to improve health disparities in low-resource settings. OBJECTIVES: This article describes the application of CBPR and UCD principles to the development of iDecide/Decido, an interactive, tailored, web-based diabetes medication education and decision support tool delivered by community health workers (CHWs) to African American and Latino participants with diabetes in Southwest and Eastside Detroit. The decision aid is offered in English or Spanish and is delivered on an iPad in participants' homes. METHODS: The overlapping principles of CBPR and UCD used to develop iDecide/Decido include a user-focused or community approach, equitable academic and community partnership in all study phases, an iterative development process that relies on input from all stakeholders, and a program experience that is specified, adapted, and implemented with the target community. RESULTS: Collaboration between community members, researchers, and developers is especially evident in the program's design concept, animations, pictographs, issue cards, goal setting, tailoring, and additional CHW tools. CONCLUSIONS: The principles of CBPR and UCD can be successfully applied in developing health information tools that are easy to use and understand, interactive, and target health disparities.