Biomarker Cost-Benefit Analysis of EFNEP

NCT05558085 | Unknown

• 1 other identifier: 1843412-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Disease

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (11)

• Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention

  Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention

• Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention

  Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention

• Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention

  Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention

• Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention

  Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention

• Participant Demographics Baseline

  Baseline.

Study Arms (2)

EFNEP Group

EXPERIMENTAL

Subjects will receive the EFNEP Eat Smart Being Active class series.

Behavioral: Expanded Food and Nutrition Education Program (EFNEP)

Control Group

NO INTERVENTION

Subjects will receive no EFNEP intervention.

Interventions

Expanded Food and Nutrition Education Program (EFNEP) BEHAVIORAL

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.

EFNEP Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Free-Living
• Speaks and understands English and/or Spanish
• Income at or below 185% of the Federal Poverty Line

You may not qualify if:

• Being pregnant, nursing, and/or less than 9-months postpartum

Sponsors & Collaborators

• South Dakota State University: lead
• University of Idaho: collaborator
• University of Maryland, College Park: collaborator
• Washington State University: collaborator
• Michigan State University: collaborator
• Colorado State University: collaborator
• University of Florida: collaborator

Study Sites (4)

Colorado State University

Fort Collins, Colorado, 80523, United States

NOT YET RECRUITING

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

University of Maryland

College Park, Maryland, 20742, United States

RECRUITING

Washington State University

Pullman, Washington, 99164, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea M Leschewski, PhD

CONTACT

517-927-3487; andrea.leschewski@sdstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: September 28, 2022
• Study Start: September 26, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)