Community-based SMA program
In partnership with healthcare system-based community engagement staff, the Center for Functional Medicine designed a community-based SMA program for people living in a resource-challenged Cleveland neighborhood. The community-based SMA program was offered as a community benefit and adapted from the clinic-based SMA program . The clinic-based SMA from the Center for Functional Medicine is a 10-week program that provides education related to nutrition and lifestyle and provides behavioral health recommendations . Providers deliver education and care in a shared environment plus a brief, individual medical assessment. Health coaches provide education related to exercise and movement, sleep, stress reduction and tools to support lasting behavioral change. Dietitians focus on the use of food as medicine, and support participants in the implementation of a food plan that encourages consumption of whole, unprocessed foods. By the end, participants are empowered to make positive decisions regarding food and become advocates within their homes and communities. For the community-based adaption, the SMA focused on weight management utilizing a cardiometabolic food plan similar to the Mediterranean Diet . It consisted of weekly, in-person group sessions with four sessions led by a clinical practitioner (PA-C) and health coach, and six sessions led by a registered dietitian. Each session lasted for 1–2 h.
The community-based SMA sessions delivered nutrition and lifestyle-related education, provided participants with educational tools, and fostered open discussion. Participants were provided customized shopping lists for cooking and menu options for eating out. A cooking demonstration session helped participants appreciate how to prepare certain foods. As part of the SMA, community participants received in-kind laboratory testing, dietary supplementation (Pure Lean Pure Pack and Vitamin D (Pure Encapsulations, LLC)), and weekly food delivery (Freshly, Inc.) for themselves and three additional members of their household.
Study design and population
The study design was a mixed-methods, pre-post survey of a community-based SMA. Prior to the start of the SMA, participants self-completed a written survey and provided baseline biometric measurements and laboratory testing. At 3 months (after completion of the SMA), participants self-completed a written post-SMA survey and provided post-SMA biometrics and laboratory testing. We also conducted a focus group discussion among the SMA participants to discuss their experiences with the community-based SMA program at 3 months. We repeated biometric testing at 6 months (e.g., 3 months after completion of the SMA) and conducted a second focus group with the SMA participants to explore retention of knowledge and habits.
The community-based SMA program was held at the Langston Hughes Community Health and Education Center in the Fairfax neighborhood of Cleveland, Ohio. SMA participants lived in the Fairfax neighborhood. Fairfax is home to over 6,000 people with 94% identifying as Black or African American and 62% having a high school diploma or less educational attainment . The majority of households are in or near poverty which is a result of years of redlining, disinvestment, and population decline . The neighborhood population suffers from a number of health disparities compounded by social determinants of health, such as higher rates of heart disease, cancer, diabetes, and kidney disease than the surrounding areas.
Study participants had to be ≥ 18 years old, attend at least one community-based SMA session, and have previously participated in prior health education activities at the Langston Hughes Center. Exclusion criteria included inability to complete paper surveys and/or inability to sit through a 60-minute focus group discussion. All participants provided written consent to participate in the research study.
We also conducted five programmatic stakeholder interviews to discuss the implementation of the community-based SMA program. Programmatic stakeholders were those who provided administrative support and/or delivered the program.
Survey and biometrics
SMA participants completed a written survey at baseline and 3 months (post-SMA). Survey items included demographic information and questions on wellness indices , food security , self-efficacy , and trust in medical research [16, 17] that were adapted from validated instruments. Wellness indices were adapted from the Behavioral Risk Factor Surveillance System Survey and included self-reported health status, fruit/vegetable intake, physical activity, sleep duration, stress levels, alcohol and tobacco use . Survey responses on food security, self-efficacy, and trust in medical research were on a 5-point Likert scale from strongly disagree to strongly agree. Food security was assessed by two validated items: (1) Within the past 30 days, we worried whether food would run out before we got money to buy more and (2) Within the past 30 days, the food we bought just didn’t last and we didn’t have money to get more . General self-efficacy was assessed by 8 items with possible scores ranging from 8 to 40; higher scores represent greater perceived self-efficacy . Trust in medical researchers was assessed by 5 items with scores ranging from 5 to 25; higher scores represent greater trust . Participants received $10 for each survey completion.
Weight and blood pressure were assessed at baseline, 3 months, and 6 months. Laboratory testing for hemoglobin A1c (HbA1c), fasting insulin and low-density lipoprotein (LDL) cholesterol levels was evaluated at baseline and 3 months.
Focus groups and stakeholder interviews
Two, 60-minute focus groups were conducted with SMA participants and facilitated by the principal investigator (PI). The first focus group was conducted at 3 months (i.e., one week after the completion of the community-based SMA program). In order to assess program acceptability, participants were asked to discuss their experiences in the program. The second focus group was conducted at 6 months (i.e., three months following the completion of the community-based SMA program). Participants were asked to discuss factors influencing the maintenance of positive health-related behaviors. Study participants received a $30 incentive for participation in each focus group.
The PI conducted one-on-one, 60-minute stakeholder interviews using a semi-structure survey. Interviews aimed to determine general and site-specific factors associated with greater effectiveness, and to assess the acceptability and sustainability of the community-based SMA program. Interview questions were guided by standard implementation analyses  and asked the following: What are the organizational resources to carry out the intervention? What are the staff experience and capacity to carry out the intervention? What are the potential barriers and facilitators to implementing the intervention? What potential modification to the intervention would need to be made to maximize implementation?
Focus groups and stakeholder interviews were recorded by audio-tape and through researchers’ notes.
We described baseline characteristics for community-based SMA participants. Pre- and post-SMA biometrics and self-reported survey items were compared using paired t-test, McNemar’s test, or Fisher’s exact test. We compared participants’ pre- and post-SMA mean scores for general self-efficacy and trust in medical researchers. Statistical analyses were conducted using SAS version 9.4 (SAS Institute, Inc. Cary, NC). Statistical significance was established at p < 0.05. Results were shared in aggregate with the community partners and study participants.
Transcribed audio-taped sessions of focus groups were read by at least three research-eligible staff who were present during the focus group discussions. Staff first individually read transcripts and then discussed as a group using content analysis methods to identify and discuss main themes (kappa = 0.70 for inter-rater reliability). Focus group themes were shared with SMA participants to confirm accuracy. Stakeholder interviews were read by the PI and analyzed for main themes. Results were shared with stakeholders to confirm accuracy of themes associated with the implementation and sustainability of the community-based SMA program.