4. Discussion
diabetes
RECRUITMENT, DIABETES
In this pragmatic trial designed to compare the effectiveness of eCM and MNT for patients with uncontrolled diabetes, we faced multiple challenges in recruiting and engaging underserved patients in virtual nutrition interventions. After pausing the study to critically evaluate operational processes and engage participants, study team members, and other key stakeholders, we identified barriers and facilitators to study recruitment and engagement and generated actionable opportunities for process redesign [Although we leveraged our prior experience with the design and delivery of in-person culinary medicine to account for the challenges of executing a virtual intervention in an underserved study population, we encountered technological and logistical barriers to recruitment and engagement. Most patients in our safety net health system have smartphones with video capabilities. However, many eligible participants lacked internet access. Moreover, among those with internet access who enrolled, many lacked a reliable connection capable of supporting the video platform. We did have some success connecting patients with local libraries for hotspot rentals to improve connectivity. Although our initial design provided detailed phone-based guidance on the virtual platform, many patients struggled to access and use the virtual platform to join the class. We were able to help address this barrier by conducting in-person, 1:1 technology tutorials for participants to download, install, and practice using the eCM virtual platform. Additionally, a study team member remained available on standby during the eCM classes to provide support for any unexpected technological difficulties. Although virtual interventions and education programs may help address transportation and childcare barriers [Although we described the culinary medicine intervention as ‘cooking classes’ to participants, participants remained uncertain about what to expect, which was a potential barrier to recruitment and engagement. While some participants were excited by the cooking classes, others were hesitant because they did not feel confident in their cooking or felt comfortable cooking along with the instructors. These findings are similar to other studies suggesting that a lack of interest or knowledge about cooking creates uncertainty and may pose a barrier to participating in cooking classes [Preliminary findings from this redesign indicate that MNT participants had higher engagement at the first class than eCM participants even after changes were implemented; however, participants who joined the first eCM class were more likely to return, especially Spanish speakers. Notably, the eCM intervention was not directly affiliated with the health system, and classes were held in the evenings, which may play a role in eCM’s lower engagement. The MNT intervention, which was delivered using health system RDs at the patient’s primary care clinic during business hours, was more familiar to participants and likely viewed as part of their healthcare. The RDs conducted their own scheduling, reminder, and outreach calls in the case of “no show” appointments, which led to a strong rapport with study participants. Such patient-dietitian relationships are key components of successful dietary interventions; making sessions feel personal and individualized, even when delivered in a group setting, is important for building interest and engagement [Although we initially planned to distribute cooking utensils, recipe binders, and pantry staples at the community organization, low show rates for food pick-up resulted in eCM participants not having the necessary items for their class. This resulted in the differential withdrawal of participants from the eCM arm relative to the MNT arm, which did not require this additional step. Participants identified transportation, lack of familiarity with the community organization, and conflicts with food pick-up times as key barriers. Our original study design was ‘opt out’ for food assistance in collaboration with our community organization. This required a signed informed consent and HIPAA authorization to share participant information with our community organization, which posed a substantial barrier to recruitment via telephone. Given this and the participant barriers to food pick-up, we transitioned to an ‘opt in’ food distribution model, which did not require written consent and gave participants greater choice and flexibility in selecting their food resource. This model also allowed us to move the in-person eCM Orientation meeting to the participant’s primary care clinic, which was familiar and more accessible. We explored the possibility of delivering supplies directly to their home, but we did not have sufficient funding or staffing to support this. Home delivery of supplies and groceries may limit the need for shopping and help alleviate barriers to participation in virtual culinary medicine classes where participants cook in their home kitchens.