Clinical trial NCT05558085: Biomarker Cost-Benefit Analysis of EFNEP
Official title: A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers of Chronic Disease Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Disease
Keywords: Diet
Nutrition Education
Biomarker
Cost-benefit analysis
EFNEP
Lead sponsor: South Dakota State University
Sponsor class: OTHER
Collaborators: name: University of Idaho
name: University of Maryland, College Park
name: Washington State University
name: Michigan State University
name: Colorado State University
name: University of Florida
First posted: 2022-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Height from Baseline to 6 Months Post Intervention
timeFrame: Change in height measurement from baseline to 6 months post intervention
measure: Change in Height from Baseline to 12 Months Post Intervention
timeFrame: Change in height measurement from baseline to 12 months post intervention
measure: Change in Weight from Baseline to 6 Months Post Intervention
timeFrame: Change in weight measurement from baseline to 6 months post intervention
measure: Change in Weight from Baseline to 12 Months Post Intervention
timeFrame: Change in weight measurement from baseline to 12 months post intervention
measure: Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post Intervention
timeFrame: Change in Systolic and Diastolic blood pressure measurements from baseline to 6 months post intervention
measure: Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post Intervention
timeFrame: Change in Systolic and Diastolic blood pressure measurements from baseline to 12 months post intervention
measure: Change in HbA1c from Baseline to 6 Months Post Intervention
timeFrame: Change in HbA1c measurement from baseline to 6 months post intervention
measure: Change in HbA1c from Baseline to 12 Months Post Intervention
timeFrame: Change in HbA1c measurement from baseline to 12 months post intervention
Secondary outcomes:
measure: Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
timeFrame: Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
measure: Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
timeFrame: Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
measure: Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
timeFrame: Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
measure: Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
timeFrame: Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
measure: Participant Demographics Baseline
timeFrame: Baseline.
measure: Participant Demographics Post Intervention
timeFrame: Immediately Post Intervention.
measure: Participant Demographics 6 Months Post Intervention
timeFrame: 6 Months Post Intervention
measure: Participant Demographics 12 Months Post Intervention
timeFrame: 12 Months Post Intervention
measure: Participant Health Status Baseline
timeFrame: Baseline
measure: Participant Health Status 6 Months Post Intervention
timeFrame: 6 Months Post Intervention
measure: Participant Health Status 12 Months Post Intervention
timeFrame: 12 Months Post Intervention
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Pullman
country: United States
facility: Washington State University
state: Washington
Study officials:
References: