Nutrition SecurityMS CEALNCT07071064
Mississippi Community Engagement Alliance (MS CEAL): Fostering Community Solutions
A study testing Food Box + Nutrition Classes and Food Box Only in people with Nutrition Security, run by University of Mississippi Medical Center at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Security
- What is being tested?
- Food Box + Nutrition Classes and Food Box Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 May 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as Black/African American, Latinx, or Choctaw
- Age between 18-75
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Not yet recruiting
Grace Episcopal Church
Canton, Mississippi, 39046
Beth Foose, 662-571-3413, bfoose5@gmail.com
- Not yet recruiting
Choctaw Health Center
Choctaw, Mississippi, 39350
Durnene Farmer, 601-389-4500, durnene.farmer@choctaw.org
- Recruiting
Locust Grove MB Church
Greenwood, Mississippi, 38930
Jackie Hawkins, 662-299-3775, deltacommunitysolutions@outlook.com
- Recruiting
Cade Chapel - Center for Family Life, Inc.
Jackson, Mississippi, 39213
Reginald Buckley, 601-366-5463, reginaldbuckley@gmail.com
About this study
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
- Being tested
- Food Box + Nutrition Classes, Food Box Only
- Keywords
- Nutrition Security, Health Literacy, Health Promotion, Community Engaged Research
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Box + Nutrition ClassesBehavioural
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 OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Food Box + Nutrition | Experimental | Participants receive a food box as well as nutrition classes Receives: Behavioral: Food Box + Nutrition Classes |
| Food Box | Active comparator | Participants receive a food box only Receives: Behavioral: Food Box Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline until 6-months following the completion of the intervention
Secondary outcomes (8)
Perceptions and Knowledge
Supplemental Nutrition Assistance Program Education (SNAP-Ed) Around the Table Survey
Measured: Baseline until 6 months following the completion of the intervention
Dietary Intake
Automated, Self-Administered 24-hour Dietary Assessment Tool
Measured: Baseline until 6 months following the completion of the intervention
Recruitment
Program registration
Measured: Baseline until end of recruitment period
Retention
Attendance log
Measured: Baseline until completion of intervention
Delivery of Intervention
Supplemental Nutrition Assistance Program Education (SNAP-Ed) Pre/Post Survey
Measured: Baseline until 6-months after the completion of the intervention
Blood Pressure
Systolic and diastolic blood pressure, measured by study personnel using ambulatory blood pressure monitor and following AMA Cardiovascular Disease Prevention Guidelines
Measured: Baseline until 6 months following the completion of the intervention
Blood Sugar
Blood glucose levels, measured by study personnel using finger stick method
Measured: Baseline until 6 months following completion of the intervention
Cholesterol
Lipid levels, measured by study personnel using a mobile cholesterol monitor
Measured: Baseline until 6 months following completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start17 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition SecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mississippi Food Network, Mississippi State University, Center for Family Life, Inc., Locust Grove MB Church, Grace Episcopal Church, Choctaw Health Center
- Responsible party
- Principal investigator, Caroline Compretta, University of Mississippi Medical Center
- Investigators
- Caroline E Compretta, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071064
- Sponsor's protocol ID
- UMMC-IRB-2024-141
- Other IDs
- SUB-OTA No. 6922-03-COVID-S009
- Acronym
- MS CEAL
- Status last verified
- Jun 2025
- First submitted
- 6 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with the study sponsor as outlined in Notice of Award. The study sponsor will create a database for researchers to access deidentified data across all funded sites.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mississippi Community Engagement Alliance (MS CEAL): Fostering Community Solutions
- ClinicalTrials.gov ID
- NCT07071064
- Acronym / sponsor ID
- MS CEAL / UMMC-IRB-2024-141
- Conditions
- Nutrition Security
- Keywords
- Nutrition Security, Health Literacy, Health Promotion, Community Engaged Research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Mississippi Food Network, Mississippi State University, Center for Family Life, Inc., Locust Grove MB Church, Grace Episcopal Church, Choctaw Health Center
- Study start
- 17 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Food Box + Nutrition | Experimental | Behavioral: Food Box + Nutrition ClassesParticipants receive a food box as well as nutrition classes |
| Food Box | Active comparator | Behavioral: Food Box OnlyParticipants receive a food box only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-identify as Black/African American, Latinx, or Choctaw
- Age between 18-75
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Box + Nutrition ClassesThe 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. | Behavioural | Food Box + Nutrition |
| Food Box OnlyThe 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. | Behavioural | Food Box |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Yes. IPD will be shared with the study sponsor as outlined in Notice of Award. The study sponsor will create a database for researchers to access deidentified data across all funded sites.
Related trials for Nutrition Security
Not yet recruiting
Nutrition Intervention Optimization to Better Utilize Resources and Support Health
Diabete Type 2, Obesity & Overweight
Recruiting
Feasibility of an ADAPTive Intervention to Improve Food Security and Maternal-Child Health
Food Insecurity, Pregnancy
Recruiting
Cooking HEalthy and Facilitating Early Childhood Development: CHEF-ED Study
Teaching Healthy Cooking Skills to Parents and Their Preschool Children
Not yet recruiting
Qungasvik (Toolbox)-Healthy Hearts: A Cultural Approach to Reducing Chronic Disease Risk
Cardio Vascular Disease, Cerebro Vascular Disease
Recruiting
Ultra-Processing and Nutritional Quality: Glycemic Response, Appetite, Dietary Energy Intake, and Eating Rate
Eating, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline E Compretta principal investigator
University of Mississippi Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Box + Nutrition Classes and Food Box Only in people with Nutrition Security, run by University of Mississippi Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary M Saulters (601-815-8339, msaulters@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Consumption (time frame: Baseline until 6-months following the completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.