Mississippi Community Engagement Alliance (MS CEAL): Fostering Community Solutions

NCT07071064 | Recruiting

• 2 other identifiers: UMMC-IRB-2024-141SUB-OTA No. 6922-03-COVID-S009
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 4

Brief Summary

The Mississippi Community Engagement Alliance (MS CEAL) Team proposes to address the complexities of Mississippi's health issues and social determinants of health through its Fostering Community Solutions (FOCUS) Project, with two objectives: (1) advance the health and wellbeing of Mississippi's populations experiencing differing health outcomes; and (2) enhance the resilience and power within communities to disseminate and implement evidence-based interventions. This study's specific aims include: (1) examine whether the inclusion of a nutrition education program increases fruit and vegetable consumption in a food box distribution program and (2) recruit and train community nutrition liaisons to implement sustainable community strategies to longitudinally support nutrition security. The primary outcome for the first specific aim will be fruit and vegetable consumption. Secondary outcome measures will include changes in perceptions and knowledge related to food consumption and dietary intake. Clinical outcomes will include changes in blood pressure, blood sugar, and cholesterol. For Specific Aim 2, outcomes will include the ability to recruit community nutrition liaisons at each site, the number of trainings, pre/post training assessments, and outreach metrics.

Conditions

Nutrition Security

Keywords

Nutrition Security; Health Literacy; Health Promotion; Community Engaged Research

Outcome Measures

Primary Outcomes (1)

• Dietary Consumption

  Visually Enhanced Food Behavior Checklist and Community Engagement Alliance (CEAL) Common Survey Questions 13-17. The surveys will be analyzed using a "sum of boxes" approach. Each participant has a potential score of 0-20, with higher scores indicating better dietary habits.

  Baseline until 6-months following the completion of the intervention

Secondary Outcomes (8)

• Perceptions and Knowledge

  Baseline until 6 months following the completion of the intervention

• Dietary Intake

  Baseline until 6 months following the completion of the intervention

• Recruitment

  Baseline until end of recruitment period

• Retention

  Baseline until completion of intervention

• Delivery of Intervention

  Baseline until 6-months after the completion of the intervention

Study Arms (2)

Food Box + Nutrition

EXPERIMENTAL

Participants receive a food box as well as nutrition classes

Behavioral: Food Box + Nutrition Classes

Food Box

ACTIVE COMPARATOR

Participants receive a food box only

Behavioral: Food Box Only

Interventions

Food Box + Nutrition Classes BEHAVIORAL

The Nutrition Security Intervention is a 12-month project enrolling 400 adults across four sites. Participants will receive the intervention for 6 months, with a 9-month and 12-month in person follow-up. Individuals receiving this intervention will receive bi-weekly food boxes, containing 15-20 pounds of fresh produce, grains, and legumes. They will also participate in a bi-weekly nutrition class, led by a Registered Dietician.

Food Box + Nutrition

Food Box Only BEHAVIORAL

The intervention is a 12-month project enrolling 400 adults across four partner sites. Participants will receive the intervention for 6 months, with a 9-month and 12-month in person follow-up. In this intervention, participants will receive a bi-weekly food box only (no nutrition education) during the intervention period. They will have the opportunity to participate in the educational component after the completion of the intervention period.

Food Box

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as Black/African American, Latinx, or Choctaw
• Age between 18-75

You may not qualify if:

• Cognitive impairment
• Pregnant or plans to become pregnant within 12 months
• Currently enrolled in a food box delivery program or nutrition education program
• Food allergies that will be exacerbated with food box distribution

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• Mississippi Food Network: collaborator
• Mississippi State University: collaborator
• Center for Family Life, Inc.: collaborator
• Locust Grove MB Church: collaborator
• Grace Episcopal Church: collaborator
• Choctaw Health Center: collaborator

Study Sites (4)

Grace Episcopal Church

Canton, Mississippi, 39046, United States

NOT YET RECRUITING

Choctaw Health Center

Choctaw, Mississippi, 39350, United States

NOT YET RECRUITING

Locust Grove MB Church

Greenwood, Mississippi, 38930, United States

RECRUITING

Cade Chapel - Center for Family Life, Inc.

Jackson, Mississippi, 39213, United States

RECRUITING

Study Officials

• Caroline E Compretta

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary M Saulters

CONTACT

601-815-8339; msaulters@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Vice Chancellor for Research

Model Details: In this study, individuals at each site will be randomly assigned to either the intervention group, which will receive the food boxes and nutrition education, or the control group, which will receive food boxes. Participants assigned to the control group will be offered the nutrition education program after data collection is complete. The project will employ simple randomization at a one-to-one basis as participants are randomized using random number generator. By measuring key process and clinical indicators before and after the intervention, the study team will assess the impact of the program on participants' nutritional status and overall health.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 17, 2025
• Study Start: May 17, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: January 2026
• Access Criteria: Researchers will be able to access deidentified data from all partner sites via the NIH CEAL website.

Locations

US (4)