EFNEP for Chronic Disease

Not currently recruiting at 3 trial locations

Overseen By Andrea M Leschewski, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: South Dakota State University

Disqualifiers: Pregnancy, Nursing, Less than 9-months postpartum

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the nutrition education program EFNEP (Expanded Food and Nutrition Education Program) can improve health markers such as body weight, blood pressure, and blood sugar levels, particularly for individuals with ongoing health issues. The researchers aim to determine if these improvements can be sustained over time and if the program is cost-effective. Participants will either join the EFNEP program or be in a control group without the intervention. The trial seeks English or Spanish speakers who live independently and have an income at or below 185% of the Federal Poverty Line. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance community health and nutrition education.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the EFNEP intervention is safe for participants?

Research has shown that the Expanded Food and Nutrition Education Program (EFNEP) is safe for participants. This well-known U.S. program teaches nutrition, particularly to those with lower incomes. Studies have found that EFNEP helps individuals eat healthier, manage food budgets more effectively, and handle food safely. These benefits suggest that the program is well-received and causes no harm. Participants frequently report positive changes in their eating and lifestyle habits after completing the program, with no negative side effects. Overall, EFNEP's long history and widespread use underscore its safety and effectiveness in promoting healthier living. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Expanded Food and Nutrition Education Program (EFNEP) for chronic disease because it takes a unique approach compared to standard medical treatments. Unlike typical treatments that might involve medication or surgery, EFNEP focuses on education and lifestyle changes through a series of classes called "Eat Smart Being Active." This program empowers individuals by teaching them how to make healthier food choices and incorporate physical activity into their daily lives, potentially leading to sustainable long-term health improvements. By targeting behavioral change, EFNEP could help address the root causes of chronic diseases rather than just managing symptoms.

What evidence suggests that EFNEP is effective for chronic disease prevention?

Research has shown that the Expanded Food and Nutrition Education Program (EFNEP) can quickly improve participants' eating habits, though maintaining these improvements over time can be challenging. Studies confirm that EFNEP effectively helps low-income families enhance their diets, nutrition, and physical activity. In this trial, participants in the EFNEP Group will receive the EFNEP Eat Smart Being Active class series, while the Control Group will not receive any EFNEP intervention. A planned analysis will assess how well EFNEP affects important health measures like body weight, blood pressure, and blood sugar levels. This program uses practical learning and science to help people make lasting changes to their health habits. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults living with chronic diseases who have an income at or below 185% of the Federal Poverty Line. Participants must speak and understand English or Spanish, be free-living, and not currently pregnant, nursing, or less than 9-months postpartum.

Inclusion Criteria

Income at or below 185% of the Federal Poverty Line

Free-Living

I can speak and understand either English or Spanish.

Exclusion Criteria

Being less than 9-months postpartum

Being pregnant

I am currently breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-EFNEP Baseline Measurement

Biomarkers (BMI, blood pressure, HbA1c) are measured for participants before the EFNEP intervention

1 week

1 visit (in-person)

EFNEP Intervention

Participants receive the EFNEP Eat Smart Being Active class series

6 months

6-Month Post-EFNEP Follow-up

Biomarkers and participant demographics are measured 6 months after the EFNEP intervention

1 week

1 visit (in-person)

12-Month Post-EFNEP Follow-up

Biomarkers and participant health status are measured 12 months after the EFNEP intervention

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Expanded Food and Nutrition Education Program (EFNEP)

Trial Overview The study tests if the Expanded Food and Nutrition Education Program (EFNEP) is cost-effective in improving health markers related to chronic disease. It will compare changes in BMI, blood pressure, and HbA1c levels before the program starts, then again at six months and one year after completion.

How Is the Trial Designed?

Group I: EFNEP Group Experimental Treatment 1 Intervention

Subjects will receive the EFNEP Eat Smart Being Active class series.

Group II: Control Group Active Control 1 Intervention

Subjects will receive no EFNEP intervention.

Who Is Running the Clinical Trial?

South Dakota State University

Lead Sponsor

Trials

21

Recruited

10,100+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

University of Idaho

Collaborator

Trials

21

Recruited

2,800+

Washington State University

Collaborator

Trials

114

Recruited

58,800+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499404621000907

Effectiveness of Expanded Food and Nutrition Education ... This review found a consistent, immediate improvement in nutrition behaviors after program participation but poor retention over time.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39254620/

A Proposed Cost-Benefit Analysis of Adult EFNEP Utilizing ... Linear mixed models will be used to assess whether adult EFNEP has a significant (P < 0.01) impact on 3 chronic disease biomarkers.

3. nifa.usda.gov nifa.usda.gov/grants/programs/capacity-grants/expanded-food-nutrition-education-program-efnep/impacts-reporting-national-efnep-reports

Impacts and Reporting: National EFNEP Reports EFNEP reaches low-income families, improves diets, nutrition, and physical activity. Annual impact reports and national data reports are ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1499404623003457

A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers ... Project results will provide objective estimates of the economic value generated by EFNEP through chronic disease risk reduction and provide insight to support ...

5. nifa.usda.gov nifa.usda.gov/grants/programs/capacity-grants/expanded-food-nutrition-education-program-efnep

Expanded Food and Nutrition Education Program (EFNEP) EFNEP combines hands-on learning, applied science, and program data to ensure program effectiveness, efficiency, and accountability.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10413688/

Effect of a comprehensive nutrition education program on ... As seen, a significant improvement in the quality of diet, physical activity, food safety, and food resource management scores was observed ...

7. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1427998.pdf

Development and Evaluation of Impact Statements for the ... EFNEP participants report improved dietary behaviors such as increased fruit and vegetable con- sumption and decreased SSB consumption, both of ...