Community SMA Program
In partnership with health system community engagement staff, the Center for Functional Medicine designed a community-based SMA program for people living in a resource-constrained Cleveland neighborhood. The Community SMA program was offered as a community benefit and adapted from the SMA in-clinic program . The Center for Functional Medicine’s in-clinic SMA is a 10-week program that provides nutrition and lifestyle education and provides behavioral health recommendations . Providers provide education and care in a shared environment, along with a brief individual medical assessment. Health coaches provide education related to exercise and movement, sleep, stress reduction, and tools to support lasting behavior change. Dietitians focus on using food as medicine and support participants in implementing a food plan that encourages the consumption of whole, unprocessed foods. Upon completion, participants are empowered to make positive decisions about food and become advocates within their homes and communities. For community adaptation, the SMA focused on weight management using a cardiometabolic eating 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 1 to 2 hours.
SMA’s community sessions provided nutrition and lifestyle education, provided participants with educational tools, and encouraged open discussion. Participants received personalized shopping lists for cooking and menu options for dining out. A culinary demonstration session allowed participants to appreciate how to prepare certain foods. As part of the SMA, community participants received in-kind laboratory testing, dietary supplements (Pure Lean Pure Pack and Vitamin D (Pure Encapsulations, LLC)), and weekly food delivery (Freshly, Inc.) for themselves and three other 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 basic biometric measurements and lab tests. At 3 months (after completion of the SMA), participants self-completed a written post-SMA survey and provided biometric data and post-SMA lab tests. We also hosted a focus group discussion among SMA participants to discuss their experiences with the Community SMA program at 3 months. We repeated the biometric tests at 6 months (eg, 3 months after the end of the SMA) and organized a second focus group with the SMA participants to explore the retention of knowledge and habits.
The SMA Community Program was held at the Langston Hughes Community Health and Education Center in the Fairfax neighborhood of Cleveland, Ohio. The SMA participants lived in the Fairfax neighborhood. Fairfax is home to more than 6,000 people, 94% of whom identify as Black or African American and 62% have a high school diploma or less education. . Majority of households are in or near poverty, a result of years of redlining, divestment and population decline . The neighborhood’s 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 surrounding areas.
Study participants had to be ≥ 18 years old, attend at least one community SMA session, and have previously participated in health education activities at the Langston Hughes Center. Exclusion criteria included inability to respond to paper surveys and/or inability to participate in a 60-minute focus group discussion. All participants provided written consent to participate in the research study.
We also conducted five interviews with programmatic stakeholders to discuss the implementation of the Community SMA program. Program stakeholders were those who provided administrative support and/or delivered the program.
Investigation and biometrics
SMA participants completed a written survey at baseline and 3 months (after SMA). Survey items included demographic information and questions on well-being indices food safety self-efficacy and trust in medical research [16, 17] which have been adapted from validated instruments. Wellbeing indices were adapted from the Behavioral Risk Factor Surveillance System survey and included self-reported health status, fruit/vegetable consumption, physical activity, sleep duration , stress levels, alcohol and tobacco consumption . Food safety, self-efficacy, and confidence in medical research survey responses were on a 5-point Likert scale ranging from strongly disagree to strongly agree. Food security was assessed by two validated items: (1) In the past 30 days we worried about whether food would run out before we had money to buy more and (2) During of the last 30 days, the food we bought has simply not been consumed. last and we had no 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 confidence . Participants received $10 for each questionnaire completed.
Weight and blood pressure were assessed at baseline, 3 months, and 6 months. Laboratory tests for hemoglobin A1c (HbA1c), fasting insulin, and low-density lipoprotein (LDL) cholesterol levels were assessed at baseline and at 3 months.
Focus groups and interviews with stakeholders
Two 60-minute focus groups were held with SMA participants and moderated by the principal investigator (PI). The first focus group was conducted at 3 months (i.e. one week after the end of the SMA community program). In order to assess the acceptability of the program, participants were asked to discuss their experiences in the program. The second focus group was conducted at 6 months (i.e. three months after the end 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 participating in each focus group.
The PI conducted 60-minute individual interviews with stakeholders using a semi-structured survey. The 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 analyzes  and posed the following question: What are the organizational resources to carry out the intervention? What is the experience and capacity of staff to carry out the intervention? What are the potential barriers and facilitators to implementing the intervention? What potential modification of the intervention would need to be made to maximize implementation?
The focus groups and stakeholder interviews were audio-recorded and in the researchers’ notes.
We have described the basic characteristics of community participants in the SMA. Pre- and post-SMA biometric items and self-reported survey items were compared using paired t-test, McNemar’s test, or Fisher’s exact test. We compared participants’ mean scores before and after SMA for general self-efficacy and trust in medical researchers. Statistical analyzes were performed using SAS version 9.4 (SAS Institute, Inc. Cary, NC). Statistical significance was established at p
Transcribed audio focus group sessions were read by at least three research-eligible staff members who were present during the focus group discussions. Staff first read the transcripts individually, then discussed as a group using content analysis methods to identify and discuss major themes (kappa = 0.70 for inter-rater reliability). Themes from the focus groups were shared with SMA participants to confirm accuracy. The stakeholder interviews were read by the PI and analyzed for the main themes. The results were shared with stakeholders to confirm the accuracy of the themes associated with the implementation and sustainability of the community-based SMA program.