A Mixed-Methods, Randomized Clinical Trial to Examine Feasibility of a Mindfulness-Based Stress Management and Diabetes Risk Reduction Intervention for African Americans with Prediabetes

Table 7

Key intervention design modifications for a future, definitive RCT.

Participant qualitative feedback	Intervention design modifications
Timing of intervention sessions
Participants shared feedback to guide scheduling, including consideration of life demands, familial obligations, and weekend and evening sessions.; Mixed information was shared, including having longer sessions with fewer total session days. In contrast to those who suggested fewer session days, some participants requested more face-to-face sessions, twice-monthly booster sessions, additional half-day sessions, and a longer follow-up period beyond six months. Others verbalized appreciation for having sessions at a school in the target community versus at the medical center.	Eight sessions will be held one evening per week, every other week, and across sixteen weeks. Participants who have to miss a session will have the opportunity to make up that session during the week that class is not scheduled. Session one will include intervention orientation components designed to promote equitable and high credibility among both intervention arms. One, half-day Saturday retreat will be held. After the 8 weekly sessions, once-per-month booster sessions take place, with the availability of make-up sessions. This adds flexibility to the intervention design and accounts for the likelihood that life obligations may cause participants to miss sessions. Intervention content will include mindfulness strategies to help participants integrate and sustain self-care/health-promoting behaviors in the context of demands and caregiving obligations.; Because the eight intervention sessions will be implemented across 16 weeks, followed by 6 months of booster sessions, participants will be engaged in the study’s intervention activities during a time span that is two months longer than the feasibility study.; During recruitment of each cohort, participants will receive a query about familial obligations during weeknights and Saturdays. This information will be used to schedule interventions sessions on days that are most feasible for the majority of participants.
Location of intervention sessions and data collection
Some participants expressed the potential benefits of having sessions at a more centrally located community or church setting. Some also shared challenges to their attendance at the UNC CTRC hospital-based laboratory data collection visits including traffic, parking, and medical center location. Individuals’ suggestions for overcoming these challenges included having nighttime appointments and an off-site location, such as a local community clinic.	Data collection and intervention sessions will be held at community locations that are conveniently located, with adequate parking, and adjacent to local bus stops. Community locations will have private areas for lab testing, survey data collection, and space for health education and exercise sessions.
Implementation of intervention strategies at home
Participants reported challenges with “making time” to meditate and do the assigned homework. Some noted challenges with balancing work and family obligations to meditate consistently, cook, and eat healthier foods and integrate physical activity into their lives. Individual participants made suggestions regarding the need for increased group and peer support, enhanced accountability, access to study-specific videos to enhance exercise, and tips for organizing time to incorporate exercise and healthy behavioral change.	Web-accessible exercise and mindfulness videos, a mindfulness app to support home practice, a phone app for nutrition monitoring, onsite childcare, reminder phone calls, and a peer support “buddy system” will be implemented to provide encouragement and support to participants as they incorporate/maintain healthy behaviors into their routines.

The investigators will work with a community advisory board during the design and implementation of a larger definitive RCT to maximize cultural relevance, acceptability, outreach/recruitment, impact, and future translation and dissemination of the project.