EFNEP for Chronic Disease

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

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this integrated project is to assess whether EFNEP is a cost-effective nutrition education intervention that generates sustained improvement in chronic disease biomarkers. This project will be unique in its use of objective biomarkers, instead of self-reported behaviors, to quantify the economic benefits generated by EFNEP through chronic disease prevention. A paired location untreated control group quasi-experimental design will be employed, with biomarkers (BMI, blood pressure, HbA1c) measured for 500 adults across four representative state EFNEP programs (CO, FL, MD, WA). Biomarkers will be measured pre-EFNEP, 6-months-post-EFNEP and 1-year-post-EFNEP. Analytical techniques will include cost-benefit, bivariate, and multivariate analyses.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+