Recruiting

Cost-Benefit Analysis

Sponsor:

South Dakota State University

Code:

NCT05558085

Conditions

Chronic Disease

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Expanded Food and Nutrition Education Program (EFNEP)

Study Details

Brief summary:

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.

Conditions

Chronic Disease

Study ID

NCT05558085

Start date

Sep 26, 2022

Status verified date

Apr, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Free-Living
  • Speaks and understands English and/or Spanish
  • Income at or below 185% of the Federal Poverty Line

Exclusion Criteria:

  • Being pregnant, nursing, and/or less than 9-months postpartum

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: EFNEP Group

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

no intervention: Control Group

Subjects will receive no EFNEP intervention.

Interventions

Expanded Food and Nutrition Education Program (EFNEP)

Subjects will participate in nine hands-on EFNEP lessons to teach nutrition, healthy lifestyle choices, physical activity, food preparation, food safety, and food resource management.

Primary outcome measure

  • Change in Height from Baseline to 6 Months Post Intervention [ Time Frame: Change in height measurement from baseline to 6 months post intervention ]
  • Change in Height from Baseline to 12 Months Post Intervention [ Time Frame: Change in height measurement from baseline to 12 months post intervention ]
  • Change in Weight from Baseline to 6 Months Post Intervention [ Time Frame: Change in weight measurement from baseline to 6 months post intervention ]
  • Change in Weight from Baseline to 12 Months Post Intervention [ Time Frame: Change in weight measurement from baseline to 12 months post intervention ]
  • Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post Intervention [ Time Frame: Change in Systolic and Diastolic blood pressure measurements from baseline to 6 months post intervention ]
  • Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post Intervention [ Time Frame: Change in Systolic and Diastolic blood pressure measurements from baseline to 12 months post intervention ]
  • Change in HbA1c from Baseline to 6 Months Post Intervention [ Time Frame: Change in HbA1c measurement from baseline to 6 months post intervention ]
  • Change in HbA1c from Baseline to 12 Months Post Intervention [ Time Frame: Change in HbA1c measurement from baseline to 12 months post intervention ]

Central Contacts and Locations

Central contacts

Andrea M Leschewski, PhD

517-927-3487andrea.leschewski@sdstate.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Karla Shelnutt, PhD

352-273-3535kpagan@ufl.edu

University of Maryland

Recruiting

College Park, Maryland, United States, 20742

Contacts

Margaret Udahogora

301-405-1018mudahogo@umd.edu

Washington State University

Recruiting

Pullman, Washington, United States, 99164

Contacts

Kylie Pybus

509-477-2190kpybus@spokanecounty.org

More Information

Sponsor

South Dakota State University

Last update posted

Apr 12, 2023

Last verified

Apr, 2023

Keywords

  • Diet
  • Nutrition Education
  • Biomarker
  • Cost-benefit analysis
  • EFNEP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by South Dakota State University on 2023-04-12.