Multiphase optimization strategy to establish optimal delivery of nutrition-related services in healthcare settings: A step towards clinical trial.

ABSTRACT

BACKGROUND: Minorities living in the Southern US generally have greater incidence and prevalence of cardiometabolic diseases compared to other groups. Cardiometabolic disease prevalence and risk can be reduced by focusing on diet and lifestyle modifications. There is need for holistic and integrated care models for community-based healthcare organizations who are already working with minorities. This research aimed to select and optimize essential psychosocial and structural components to address diet behaviors among racial/ethnic minorities, and/or disadvantaged background young to middle aged adult populations in Mississippi. METHODS: Nutrition360 was guided by a community-academic team using a participatory approach and included a preparation and two optimization phases to examine different approaches to dietary interventions utilizing the multiphase optimization strategy. Each intervention arm included three different modalities to identify the most feasible delivery method. The intervention was conducted at a community-based, outpatient healthcare center located in Jackson, MS. Eligible participants were between 25 and 50 years old, residents of Jackson metropolitan area, at risk for cardiovascular disease-related premature mortality, and had internet access. Individuals who completed baseline surveys were randomly assigned to an intervention group and then to modality order. Co-primary outcomes were research participant burden and cost-effectiveness and secondary outcomes were attendance, and dietary measures. RESULTS: Thirty-one, African American individuals with a mean age of 40.5 years completed baseline surveys and were randomized to an intervention program. CONCLUSION: The two most feasible and cost-effective interventions will be combined to further test this model's delivery in the real-world setting as part of the next optimization phase. REGISTRATION ClinicalTrials.gov, NCT06286618. https//clinicaltrials.gov/study/NCT06286618.