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

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.

Conditions

• Cardiovascular Diseases

Interventions

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.

Sponsors & Collaborators

• My Brother's Keeper

  collaborator UNKNOWN

• University of Southern Mississippi

  lead OTHER

Principal Investigators

• June Gipson, PhD · My Brother's Keeper, Inc.

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

25 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-09-24

Completion

2024-09-24

Countries

• United States

Study Locations