Biomarker Cost-Benefit Analysis of EFNEP

NCT ID: NCT05558085

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EFNEP Group

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

Group Type EXPERIMENTAL

Expanded Food and Nutrition Education Program (EFNEP)

Intervention Type 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.

Control Group

Subjects will receive no EFNEP intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Idaho

OTHER

Sponsor Role collaborator

University of Maryland, College Park

OTHER

Sponsor Role collaborator

Washington State University

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role collaborator

Colorado State University

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

South Dakota State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Colorado State University

Fort Collins, Colorado, United States

Site Status NOT_YET_RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

University of Maryland

College Park, Maryland, United States

Site Status RECRUITING

Washington State University

Pullman, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andrea M Leschewski, PhD

Role: CONTACT

517-927-3487

Facility Contacts

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Susan Baker

Role: primary

970-491-5798

Karla Shelnutt, PhD

Role: primary

352-273-3535

Margaret Udahogora

Role: primary

301-405-1018

Kylie Pybus

Role: primary

509-477-2190

Other Identifiers

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1843412-1

Identifier Type: -

Identifier Source: org_study_id

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