Biomarker Cost-Benefit Analysis of EFNEP
- Conditions
- Chronic Disease
- Interventions
- Behavioral: Expanded Food and Nutrition Education Program (EFNEP)
- Registration Number
- NCT05558085
- Lead Sponsor
- South Dakota State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Free-Living
- Speaks and understands English and/or Spanish
- Income at or below 185% of the Federal Poverty Line
- Being pregnant, nursing, and/or less than 9-months postpartum
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EFNEP Group Expanded Food and Nutrition Education Program (EFNEP) Subjects will receive the EFNEP Eat Smart Being Active class series.
- Primary Outcome Measures
Name Time Method Change in Height from Baseline to 6 Months Post Intervention Change in height measurement from baseline to 6 months post intervention Height (m) is measured using a portable stadiometer.
Change in Height from Baseline to 12 Months Post Intervention Change in height measurement from baseline to 12 months post intervention Height (m) is measured using a portable stadiometer.
Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post Intervention Change in Systolic and Diastolic blood pressure measurements from baseline to 12 months post intervention Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Change in Weight from Baseline to 12 Months Post Intervention Change in weight measurement from baseline to 12 months post intervention Weight (kg) is measured using a portable scale.
Change in Weight from Baseline to 6 Months Post Intervention Change in weight measurement from baseline to 6 months post intervention Weight (kg) is measured using a portable scale.
Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post Intervention Change in Systolic and Diastolic blood pressure measurements from baseline to 6 months post intervention Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Change in HbA1c from Baseline to 6 Months Post Intervention Change in HbA1c measurement from baseline to 6 months post intervention HbA1c is measured using A1CNow monitor.
Change in HbA1c from Baseline to 12 Months Post Intervention Change in HbA1c measurement from baseline to 12 months post intervention HbA1c is measured using A1CNow monitor.
- Secondary Outcome Measures
Name Time Method Participant Demographics Baseline Baseline. A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics 12 Months Post Intervention 12 Months Post Intervention A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Participant Health Status Baseline Baseline A 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 12 Months Post Intervention 12 Months Post Intervention A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Participant Demographics 6 Months Post Intervention 6 Months Post Intervention A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention 24-hour dietary recalls will be administered to capture change in food and beverage intake.
Participant Demographics Post Intervention Immediately Post Intervention. A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention 24-hour dietary recalls will be administered to capture change in food and beverage intake.
Participant Health Status 6 Months Post Intervention 6 Months Post Intervention A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Trial Locations
- Locations (4)
Colorado State University
🇺🇸Fort Collins, Colorado, United States
University of Maryland
🇺🇸College Park, Maryland, United States
Washington State University
🇺🇸Pullman, Washington, United States
University of Florida
🇺🇸Gainesville, Florida, United States