NCT06286618

Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians

Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Southern Mississippi · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi.

Detailed description

The study is designed based on the multiphase optimization strategy (MOST), which includes three phases to prepare or screen, optimize, and evaluate multiple components of an intervention. During first optimization phase, study team will conduct essential component selection by pilot testing three common strategies used in healthcare settings to deliver structural and psychosocial interventions that address diet behaviors. The second optimization phase will include pilot testing to examine the optimization of delivery mode for the essential components identified in first phase. In each phase, participants between 25 to 50 years of age who are at risk for CVD-related premature mortality will be recruited to complete a 3-month intervention in a community based clinical setting in Mississippi. The proposed project will provide foundational knowledge for components and delivery models that are the most essential and cost-effective to improve dietary behaviors among racial/ethnic minority and disadvantaged background populations in Mississippi.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Psychosocial Intervention	Psychosocial intervention is an intensive behavioral therapy intervention to address dietary behaviors. Each intervention session is a one-on-one interaction that focuses on setting individualized dietary goals and following up on them and is delivered by trained personnel. Sessions are delivered in 3 modalities which include face-to-face, phone call, and telehealth delivery. Each participant is randomly assigned to receive 4 weeks of each modality in one of the following orders: 1) Face-to-face; Telehealth; Phone Call 2) Telehealth; Phone Call; Face-to-face 3) Phone call; Face-to-face; Telehealth.
OTHER	Structural Intervention	The structural intervention is designed to supplement the diet with food resources via three modalities: voucher-based or F/V prescription, home meal delivery, or food bank box program. The voucher-based model includes a weekly $50 gift card with a prescription for having to eat more fruits and vegetables. The home meal delivery model includes a meal subscription that supplements the diet with two meals for two people each week (four total servings worth $65 including shipping). The food bank box program consists of participants picking up a box of food weekly from a food pantry located in the outpatient clinic. Each participant is randomly assigned to receive 4 weeks of each modality in one of the following orders: 1) Voucher; Meal Delivery; Food Box 2) Meal Delivery; Food Box; Voucher 3) Food Box; Voucher; Meal Delivery.
OTHER	Traditional Psychosocial+Structural	Participants will receive a combination of psychosocial and structural intervention, based on the most feasible selections from the preparation phase of the study. The intervention will initiate in a referral-based fashion in which participants will receive referral at enrollment visit.
OTHER	Integrated Psychosocial+Structural	Participants will receive a combination of psychosocial and structural intervention, based on the most feasible selections from the preparation phase of the study. The intervention will initiate in an integrated fashion in which participants will receive immediate onboard at enrollment visit.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-09-24
• Completion: 2024-09-24
• First posted: 2024-02-29
• Last updated: 2024-12-06

Locations

1 site across 1 country: United States