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Biomarker Cost-Benefit Analysis of EFNEP

Primary Purpose

Chronic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expanded Food and Nutrition Education Program (EFNEP)
Sponsored by
South Dakota State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring Diet, Nutrition Education, Biomarker, Cost-benefit analysis, EFNEP

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Colorado State University
  • University of FloridaRecruiting
  • University of MarylandRecruiting
  • Washington State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EFNEP Group

Control Group

Arm Description

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

Subjects will receive no EFNEP intervention.

Outcomes

Primary Outcome Measures

Change in Height 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
Height (m) is measured using a portable stadiometer.
Change in Weight from Baseline to 6 Months Post Intervention
Weight (kg) is measured using a portable scale.
Change in Weight from Baseline to 12 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
Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
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 HbA1c from Baseline to 6 Months Post Intervention
HbA1c is measured using A1CNow monitor.
Change in HbA1c from Baseline to 12 Months Post Intervention
HbA1c is measured using A1CNow monitor.

Secondary Outcome Measures

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
The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
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 12 Months Post Intervention
24-hour dietary recalls will be administered to capture change in food and beverage intake.
Participant Demographics Baseline
A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics Post Intervention
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics 6 Months Post Intervention
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Participant Demographics 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
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 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.
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.

Full Information

First Posted
September 23, 2022
Last Updated
April 11, 2023
Sponsor
South Dakota State University
Collaborators
University of Idaho, University of Maryland, College Park, Washington State University, Michigan State University, Colorado State University, University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05558085
Brief Title
Biomarker Cost-Benefit Analysis of EFNEP
Official Title
A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers of Chronic Disease Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Dakota State University
Collaborators
University of Idaho, University of Maryland, College Park, Washington State University, Michigan State University, Colorado State University, University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Diet, Nutrition Education, Biomarker, Cost-benefit analysis, EFNEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EFNEP Group
Arm Type
Experimental
Arm Description
Subjects will receive the EFNEP Eat Smart Being Active class series.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects will receive no EFNEP intervention.
Intervention Type
Behavioral
Intervention Name(s)
Expanded Food and Nutrition Education Program (EFNEP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Height from Baseline to 6 Months Post Intervention
Description
Height (m) is measured using a portable stadiometer.
Time Frame
Change in height measurement from baseline to 6 months post intervention
Title
Change in Height from Baseline to 12 Months Post Intervention
Description
Height (m) is measured using a portable stadiometer.
Time Frame
Change in height measurement from baseline to 12 months post intervention
Title
Change in Weight from Baseline to 6 Months Post Intervention
Description
Weight (kg) is measured using a portable scale.
Time Frame
Change in weight measurement from baseline to 6 months post intervention
Title
Change in Weight from Baseline to 12 Months Post Intervention
Description
Weight (kg) is measured using a portable scale.
Time Frame
Change in weight measurement from baseline to 12 months post intervention
Title
Change in Systolic and Diastolic Blood Pressure from Baseline to 6 Months Post Intervention
Description
Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Time Frame
Change in Systolic and Diastolic blood pressure measurements from baseline to 6 months post intervention
Title
Change in Systolic and Diastolic Blood Pressure from Baseline to 12 Months Post Intervention
Description
Systolic and Diastolic blood pressure are measured using an OMRON Silver blood pressure monitor
Time Frame
Change in Systolic and Diastolic blood pressure measurements from baseline to 12 months post intervention
Title
Change in HbA1c from Baseline to 6 Months Post Intervention
Description
HbA1c is measured using A1CNow monitor.
Time Frame
Change in HbA1c measurement from baseline to 6 months post intervention
Title
Change in HbA1c from Baseline to 12 Months Post Intervention
Description
HbA1c is measured using A1CNow monitor.
Time Frame
Change in HbA1c measurement from baseline to 12 months post intervention
Secondary Outcome Measure Information:
Title
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
Description
The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Time Frame
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
Title
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
Description
The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Time Frame
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
Title
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
Description
24-hour dietary recalls will be administered to capture change in food and beverage intake.
Time Frame
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
Title
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
Description
24-hour dietary recalls will be administered to capture change in food and beverage intake.
Time Frame
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
Title
Participant Demographics Baseline
Description
A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.
Time Frame
Baseline.
Title
Participant Demographics Post Intervention
Description
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Time Frame
Immediately Post Intervention.
Title
Participant Demographics 6 Months Post Intervention
Description
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Time Frame
6 Months Post Intervention
Title
Participant Demographics 12 Months Post Intervention
Description
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Time Frame
12 Months Post Intervention
Title
Participant Health Status Baseline
Description
A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Time Frame
Baseline
Title
Participant Health Status 6 Months Post Intervention
Description
A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Time Frame
6 Months Post Intervention
Title
Participant Health Status 12 Months Post Intervention
Description
A Health Questionnaire will be used to identify whether participants have a health condition, take medication(s) for a health condition, and smoke.
Time Frame
12 Months Post Intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea M Leschewski, PhD
Phone
517-927-3487
Email
andrea.leschewski@sdstate.edu
Facility Information:
Facility Name
Colorado State University
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80523
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Baker
Phone
970-491-5798
Email
susan.baker@colostate.edu
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karla Shelnutt, PhD
Phone
352-273-3535
Email
kpagan@ufl.edu
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Udahogora
Phone
301-405-1018
Email
mudahogo@umd.edu
Facility Name
Washington State University
City
Pullman
State/Province
Washington
ZIP/Postal Code
99164
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kylie Pybus
Phone
509-477-2190
Email
kpybus@spokanecounty.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data will be made available on South Dakota State University's Open Access Institutional Repository, Open PRAIRIE.

Learn more about this trial

Biomarker Cost-Benefit Analysis of EFNEP

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