Food Box + Nutrition Classes for Food Insecurity

(MS CEAL Trial)

Recruiting at 3 trial locations

Overseen By Mary M Saulters

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Mississippi Medical Center

Disqualifiers: Cognitive impairment, Pregnancy, Food allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding nutrition classes to a food box program can increase fruit and vegetable consumption. Researchers seek to understand whether these classes improve knowledge and habits related to food and nutrition. Participants will receive either a food box alone or a food box with classes. The trial seeks individuals who identify as Black/African American, Latinx, or Choctaw and who are not currently in a similar program. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance community health and nutrition education.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition and food security, so it's unlikely that your medications will be affected, but you should check with the trial organizers to be sure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that food box programs combined with nutrition classes are safe and well-received. Participants report high satisfaction with the program's ease of use and the amount and quality of food provided. Reviews found no major negative effects, and the program successfully improved access to food and the quality of participants' diets. One study found that food insecurity, defined as not having enough food regularly, decreased significantly after three months in these programs. These results suggest that using food boxes along with nutrition classes is a safe and effective way to improve diet and health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Food Box + Nutrition Classes approach to tackling food insecurity because it combines immediate relief with long-term education. Unlike standard food assistance programs that simply provide food, this treatment adds nutrition classes, empowering participants with knowledge to make healthier dietary choices. By addressing both the immediate need for food and the lack of nutritional education, this approach has the potential to create lasting changes in eating habits and overall well-being.

What evidence suggests that this trial's treatments could be effective for increasing fruit and vegetable consumption?

This trial will compare two approaches to addressing food insecurity: providing a food box with nutrition classes and providing a food box only. Research has shown that combining food boxes with nutrition classes can improve dietary habits. Studies find that those receiving both food support and nutrition lessons often consume more fruits and vegetables. Participants in similar programs have reported high satisfaction with the quality and quantity of food and feel less anxious about food availability. Learning about nutrition helps in making healthier food choices and understanding good eating habits. By offering food and nutrition education, the goal is to enhance overall health and well-being. ^{2 4 6 7 8}

Who Is on the Research Team?

Caroline E Compretta

Principal Investigator

University of Mississippi Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals facing food insecurity in Mississippi. It aims to improve their health and dietary habits by providing them with a food box, with or without additional nutrition classes. Participants should be willing to have their fruit and vegetable consumption tracked, along with changes in blood pressure, sugar levels, and cholesterol.

Inclusion Criteria

Self-identify as Black/African American, Latinx, or Choctaw

I am between 18 and 75 years old.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a food box and may attend nutrition classes as part of the intervention

6 months

Regular visits for intervention delivery and monitoring

Follow-up

Participants are monitored for changes in dietary habits, blood pressure, blood sugar, and cholesterol

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Food Box + Nutrition Classes
• Food Box Only

Trial Overview The study is testing if adding nutrition education to a food box distribution program increases the intake of fruits and vegetables among participants. It also seeks to train community nutrition liaisons for long-term support in nutritional security within the community.

How Is the Trial Designed?

Group I: Food Box + Nutrition Experimental Treatment 1 Intervention

Participants receive a food box as well as nutrition classes

Group II: Food Box Active Control 1 Intervention

Participants receive a food box only

Who Is Running the Clinical Trial?

University of Mississippi Medical Center

Lead Sponsor

Trials

185

Recruited

200,000+

Mississippi Food Network

Collaborator

Mississippi State University

Collaborator

Trials

8

Recruited

3,300+

Center for Family Life, Inc.

Collaborator

Locust Grove MB Church

Collaborator

Grace Episcopal Church

Collaborator

Choctaw Health Center

Collaborator

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/19320248.2025.2490257?af=R

Viability and preliminary effectiveness of a food box ... Participants reported high satisfaction with convenience (100%), food quantity (92.1%), and food quality (84.2%). A mobile food delivery program ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10421408/

A Systematic Literature Review of Nutrition Interventions ... Overall, the most frequently measured outcome was changes in dietary intake among the study participants. The second most frequently measured ...

3. feedingamerica.org feedingamerica.org/sites/default/files/2023-07/Nutrition-Education-Evidence-Review-_f-1.pdf

Key Considerations for Nutrition Education Programs and ... The objective of this evidence review is to examine the existing evidence regarding nutrition education strategies and approaches targeting individuals,.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/aepp.13299

The impact of the Meals‐to‐You program on food insecurity We find that among participating households, those receiving more boxes had larger declines in food insecurity, especially in more remote rural areas.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831323014436

Local Food System Approaches to Address Food and ... Low-income households experience greater rates of food insecurity: 32% of households with incomes below the federal poverty line experienced food insecurity in ...

6. feedingamerica.org feedingamerica.org/sites/default/files/2024-09/HCP%20Evidence%20Review%20-%20Key%20Drivers%20to%20Improve%20Food%20Security%20and%20Health%20Outcomes_FINAL.pdf

Key Drivers to Improve Food Security and Health Outcomes We sought to review and assess existing evidence to quantify the benefits of these programs for the specific outcomes of food security, diet quality, and health ...

7. ers.usda.gov ers.usda.gov/topics/food-nutrition-assistance/food-security-in-the-us/measurement

Food Security in the U.S. - Measurement Low food security: Food-insecure households classified as having low food security have reported reduced diet quality and variety—but typically ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837765

Healthy Food Benefit Programs, Fruit and Vegetable ... The program was associated with a 5.5 percentage point (pp) (95% CI, 0.05-10.91 pp) increase in food security and a 7.5 pp (95% CI, 0.39-14.52 ...