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Biomarker Cost-Benefit Analysis of EFNEP

A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers of Chronic Disease Risk

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05558085
Enrollment
500
Registered
2022-09-28
Start date
2022-09-26
Completion date
2024-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease

Keywords

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

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.

Detailed description

According to the CDC, 60% of US adults have a diagnosed chronic disease. This indicates the need for focused efforts to change modifiable risk factors including diet and exercise. The Expanded Food and Nutrition Education Program (EFNEP) aims to prevent chronic diseases by educating and encouraging vulnerable populations to adopt a healthy diet and physical activity. Addressing the program priority area Diet, Nutrition and the Prevention of Chronic Diseases, the long-term 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. Project research objectives include analyzing EFNEP's sustained impact on chronic disease biomarkers and developing and applying a biomarker-based cost-benefit analysis methodology. Extension objectives are to develop an online cost-benefit analysis tool and webinar for nutrition education program evaluation. Education objectives are to provide graduate students with experiential learning opportunities in data collection and analysis. 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. Project results will expand the EFNEP knowledge-base, allowing for program content and delivery modifications that maximize the impact of taxpayer dollars allocated to chronic disease prevention.

Interventions

BEHAVIORALExpanded 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.

Sponsors

University of Idaho
CollaboratorOTHER
University of Maryland, College Park
CollaboratorOTHER
Washington State University
CollaboratorOTHER
Michigan State University
CollaboratorOTHER
Colorado State University
CollaboratorOTHER
University of Florida
CollaboratorOTHER
South Dakota State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Height from Baseline to 6 Months Post InterventionChange in height measurement from baseline to 6 months post interventionHeight (m) is measured using a portable stadiometer.
Change in Height from Baseline to 12 Months Post InterventionChange in height measurement from baseline to 12 months post interventionHeight (m) is measured using a portable stadiometer.
Change in Weight from Baseline to 6 Months Post InterventionChange in weight measurement from baseline to 6 months post interventionWeight (kg) is measured using a portable scale.
Change in Weight from Baseline to 12 Months Post InterventionChange in weight measurement from baseline to 12 months post interventionWeight (kg) is measured using a portable scale.
Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post InterventionChange in Systolic and Diastolic blood pressure measurements from baseline to 6 months post interventionSystolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post InterventionChange in Systolic and Diastolic blood pressure measurements from baseline to 12 months post interventionSystolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Change in HbA1c from Baseline to 6 Months Post InterventionChange in HbA1c measurement from baseline to 6 months post interventionHbA1c is measured using A1CNow monitor.
Change in HbA1c from Baseline to 12 Months Post InterventionChange in HbA1c measurement from baseline to 12 months post interventionHbA1c is measured using A1CNow monitor.

Secondary

MeasureTime frameDescription
Participant Health Status BaselineBaselineA Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post InterventionChange in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post InterventionThe EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Participant Health Status 12 Months Post Intervention12 Months Post InterventionA Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Participant Health Status 6 Months Post Intervention6 Months Post InterventionA Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post InterventionChange in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post InterventionThe EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post InterventionChange in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention24-hour dietary recalls will be administered to capture change in food and beverage intake.
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post InterventionChange in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention24-hour dietary recalls will be administered to capture change in food and beverage intake.
Participant Demographics BaselineBaseline.A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics Post InterventionImmediately Post Intervention.A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics 6 Months Post Intervention6 Months Post InterventionA range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics 12 Months Post Intervention12 Months Post InterventionA range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.

Countries

United States

Contacts

Primary ContactAndrea M Leschewski, PhD
andrea.leschewski@sdstate.edu517-927-3487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026