Biomarker Cost-Benefit Analysis of EFNEP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: Expanded Food and Nutrition Education Program (EFNEP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EFNEP Group<br>Subjects will receive the EFNEP Eat Smart Being Active class series. | Behavioral: Expanded Food and Nutrition Education Program (EFNEP)<br>* 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.<br>|
| No Intervention: Control Group<br>Subjects will receive no EFNEP intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Height from Baseline to 6 Months Post Intervention | Height (m) is measured using a portable stadiometer. | Change in height measurement from baseline to 6 months post intervention | 
| Change in Height from Baseline to 12 Months Post Intervention | Height (m) is measured using a portable stadiometer. | Change in height measurement from baseline to 12 months post intervention | 
| Change in Weight from Baseline to 6 Months Post Intervention | Weight (kg) is measured using a portable scale. | Change in weight measurement from baseline to 6 months post intervention | 
| Change in Weight from Baseline to 12 Months Post Intervention | Weight (kg) is measured using a portable scale. | 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 | Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor | 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 | Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor | 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 | HbA1c is measured using A1CNow monitor. | Change in HbA1c measurement from baseline to 6 months post intervention | 
| Change in HbA1c from Baseline to 12 Months Post Intervention | HbA1c is measured using A1CNow monitor. | Change in HbA1c measurement from baseline to 12 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 6 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 EFNEP Adult Questionnaire Responses Baseline to 12 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. | Change in 24-Hour Dietary Recalls Baseline to 6 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. | Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention | 
| Participant Demographics Baseline | A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status. | Baseline. | 
| Participant Demographics Post Intervention | A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status. | Immediately Post Intervention. | 
| Participant Demographics 6 Months Post Intervention | A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status. | 6 Months Post Intervention | 
| Participant Demographics 12 Months Post Intervention | A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status. | 12 Months Post Intervention | 
| Participant Health Status Baseline | A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke. | Baseline | 
| Participant Health Status 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. | 6 Months Post Intervention | 
| Participant Health Status 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. | 12 Months Post Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Nutrition Education, Biomarker, Cost-benefit analysis, EFNEP