Biomarker Cost-Benefit Analysis of EFNEP

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558085
• Other study ID #: 1843412-1
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: South Dakota State University
• Contact: Andrea M Leschewski, PhD
• Phone: 517-927-3487
• Email: andrea.leschewski[@]sdstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland
United States	Colorado State University	Fort Collins	Colorado
United States	University of Florida	Gainesville	Florida
United States	Washington State University	Pullman	Washington

Sponsors (7)

Lead Sponsor	Collaborator
South Dakota State University	Colorado State University, Michigan State University, University of Florida, University of Idaho, University of Maryland, College Park, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Participant Demographics Post Intervention	A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.	Immediately Post Intervention.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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