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Clinical Trials/NCT07071064
NCT07071064RecruitingNot Applicable

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

University of Mississippi Medical Center4 sites in 1 country400 target enrollmentStarted: May 17, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
400
Locations
4
Primary Endpoint
Dietary Consumption

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Food Box + Nutrition

Experimental

Participants receive a food box as well as nutrition classes

Intervention: Food Box + Nutrition Classes (Behavioral)

Food Box

Active Comparator

Participants receive a food box only

Intervention: Food Box Only (Behavioral)

Outcomes

Primary Outcomes

Dietary Consumption

Time Frame: Baseline until 6-months following the completion of the intervention

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.

Secondary Outcomes

  • Recruitment(Baseline until end of recruitment period)
  • 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)
  • Retention(Baseline until completion of intervention)
  • Delivery of Intervention(Baseline until 6-months after the completion of the intervention)
  • Blood Pressure(Baseline until 6 months following the completion of the intervention)
  • Blood Sugar(Baseline until 6 months following completion of the intervention)
  • Cholesterol(Baseline until 6 months following completion of the intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Caroline Compretta

Assistant Vice Chancellor for Research

University of Mississippi Medical Center

Study Sites (4)

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