Biomarker Cost-Benefit Analysis of EFNEP

April 11, 2023 updated by: South Dakota State University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80523
        • Not yet recruiting
        • Colorado State University
    • Florida
      • Gainesville, Florida, United States, 32611
        • Recruiting
        • University of Florida
    • Maryland
      • College Park, Maryland, United States, 20742
        • Recruiting
        • University of Maryland
    • Washington
      • Pullman, Washington, United States, 99164
        • Recruiting
        • Washington State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EFNEP Group
Subjects will receive the EFNEP Eat Smart Being Active class series.
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.
No Intervention: Control Group
Subjects will receive no EFNEP intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Height from Baseline to 6 Months Post Intervention
Time Frame: Change in height measurement 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
Time Frame: Change in height measurement 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
Time Frame: Change in weight measurement 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
Time Frame: Change in weight measurement 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
Time Frame: Change in Systolic and Diastolic blood pressure measurements 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
Time Frame: Change in Systolic and Diastolic blood pressure measurements 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
Time Frame: Change in HbA1c measurement 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
Time Frame: Change in HbA1c measurement 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Immediately 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
South Dakota State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Florida
Washington State University
Michigan State University
Colorado State University
University of Idaho
University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1843412-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified participant data will be made available on South Dakota State University's Open Access Institutional Repository, Open PRAIRIE.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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