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Recruiting NCT07071064

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

No phase Interventional Nutrition Security

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Food Box + Nutrition Classes, Food Box Only.
Who it may be relevant to
Registry conditions: Nutrition Security. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Behavioral Food Box + Nutrition Classes
    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.
  • Behavioral Food Box Only
    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.

Primary outcome measures

  • Dietary Consumption [Time frame: Baseline until 6-months following the completion of the intervention]
Secondary outcome measures (8)
  • Perceptions and Knowledge [Time frame: Baseline until 6 months following the completion of the intervention]
  • Dietary Intake [Time frame: Baseline until 6 months following the completion of the intervention]
  • Recruitment [Time frame: Baseline until end of recruitment period]
  • Retention [Time frame: Baseline until completion of intervention]
  • Delivery of Intervention [Time frame: Baseline until 6-months after the completion of the intervention]
  • Blood Pressure [Time frame: Baseline until 6 months following the completion of the intervention]
  • Blood Sugar [Time frame: Baseline until 6 months following completion of the intervention]
  • Cholesterol [Time frame: Baseline until 6 months following completion of the intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 4 centers
  • Grace Episcopal Church — Canton
  • Choctaw Health Center — Choctaw
  • Locust Grove MB Church — Greenwood
  • Cade Chapel - Center for Family Life, Inc. — Jackson

Identifiers

NCT: NCT07071064 · UMMC-IRB-2024-141 · SUB-OTA No. 6922-03-COVID-S009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗