Restaurant-based NEW Soul intervention with meal provision improves weight loss among African American adults versus meal provision alone.

BACKGROUND: African American adults have disparate rates of chronic disease, and plant-based diets pose one way to mitigate disease risk. Dissemination and implementation (D&I) studies of nutrition programs in community settings are needed to scale successful interventions. OBJECTIVE: This type 2 hybrid effectiveness trial reports outcomes of weight loss (kg), diet quality (Healthy Eating Index score), and blood pressure (mmHg), among African American adults in a 12-week nutrition intervention. METHODS: The Nutritious Eating with Soul (NEW Soul) D&I study was implemented in community settings (i.e., restaurants). African American adults with overweight or obesity (body mass index between 25 to 49.9 kg/m2) were randomized to a 12-week intervention attending weekly classes with one free weekly meal (intervention) or one free weekly meal only (control). The study took place from 2022-2025 and enrolled participants in three different restaurants in two cities - Columbia, SC, and Augusta, GA. RESULTS: The study enrolled 236 participants across six cohorts (average age 48.5±9.1 years and 81% female); cohorts ranged in size from 11 to 53. Participants in the intervention group lost more weight than participants in the control group (between group change -1.1±0.5 kgs; p=0.01), and both groups exhibited significant within-group weight loss. Participants exhibited significant within-group improvements in diet quality after 12 weeks, but there was no between-group difference (4.5±4.0; p=0.26). Participants in the control group exhibited significant improved systolic and diastolic blood pressure. No between-group differences were observed in systolic (2.0±2.0; p=.30) or diastolic blood pressure (change 1.6±1.4; p=.28). CONCLUSIONS: Restaurants are viable partners in conducting implementation research. In this D&I trial implemented in community restaurants, African American adults lost weight. Future studies should focus on implementation outcomes and continued scale up of the program. CLINICAL TRIAL REGISTRY NUMBER: NCT05659966 from Clinicaltrials.gov.