Chronic DiseaseNCT05558085
Biomarker Cost-Benefit Analysis of EFNEP
A study testing Expanded Food and Nutrition Education Program (EFNEP) in people with Chronic Disease, run by South Dakota State University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Expanded Food and Nutrition Education Program (EFNEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free-Living
- Speaks and understands English and/or Spanish
- Income at or below 185% of the Federal Poverty Line
Who cannot join
- Being pregnant, nursing, and/or less than 9-months postpartum
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
University of Maryland
College Park, Maryland, 20742
Margaret Udahogora, 301-405-1018, mudahogo@umd.edu
- Not yet recruiting
Colorado State University
Fort Collins, Colorado, 80523
Susan Baker, 970-491-5798, susan.baker@colostate.edu
- Recruiting
University of Florida
Gainesville, Florida, 32611
Karla Shelnutt, PhD, 352-273-3535, kpagan@ufl.edu
- Recruiting
Washington State University
Pullman, Washington, 99164
Kylie Pybus, 509-477-2190, kpybus@spokanecounty.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Disease
- Being tested
- Expanded Food and Nutrition Education Program (EFNEP)
- Keywords
- Diet, Nutrition Education, Biomarker, Cost-benefit analysis, EFNEP
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded Food and Nutrition Education Program (EFNEP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| EFNEP Group | Experimental | Subjects will receive the EFNEP Eat Smart Being Active class series. Receives: Behavioral: Expanded Food and Nutrition Education Program (EFNEP) |
| Control Group | No intervention | Subjects will receive no EFNEP intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Height from Baseline to 6 Months Post Intervention
Height (m) is measured using a portable stadiometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Measured: Change in EFNEP Adult Questionnaire Responses Baseline to 6 Months Post Intervention
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
The EFNEP Adult Questionnaire includes questions regarding food and physical activity behaviors.
Measured: Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
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.
Measured: Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
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.
Measured: Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
Participant Demographics Baseline
A range of participant demographics will be collected including sex, age, race/ethnicity, public assistance receipt, pregnancy status, and breastfeeding status.
Measured: Baseline.
Participant Demographics Post Intervention
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Measured: Immediately Post Intervention.
Participant Demographics 6 Months Post Intervention
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Measured: 6 Months Post Intervention
Participant Demographics 12 Months Post Intervention
A range of participant demographics will be collected including public assistance receipt, pregnancy status, and breastfeeding status.
Measured: 12 Months Post Intervention
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.
Measured: Baseline
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.
Measured: 6 Months Post Intervention
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.
Measured: 12 Months Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start26 Sep 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Dakota State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Idaho, University of Maryland, College Park, Washington State University, Michigan State University, Colorado State University, University of Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558085
- Sponsor's protocol ID
- 1843412-1
- Status last verified
- Apr 2023
- First submitted
- 23 Sep 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data will be made available on South Dakota State University's Open Access Institutional Repository, Open PRAIRIE.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cost-Benefit Analysis of EFNEP Utilizing Biomarkers of Chronic Disease Risk
- ClinicalTrials.gov ID
- NCT05558085
- Acronym / sponsor ID
- 1843412-1
- Conditions
- Chronic Disease
- Keywords
- Diet, Nutrition Education, Biomarker, Cost-benefit analysis, EFNEP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- South Dakota State UniversityUniversity, hospital or other
- Collaborators
- University of Idaho, University of Maryland, College Park, Washington State University, Michigan State University, Colorado State University, University of Florida
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EFNEP Group | Experimental | Behavioral: Expanded Food and Nutrition Education Program (EFNEP)Subjects will receive the EFNEP Eat Smart Being Active class series. |
| Control Group | No intervention | –Subjects will receive no EFNEP intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Free-Living
- Speaks and understands English and/or Spanish
- Income at or below 185% of the Federal Poverty Line
Key exclusion criteria (1 listed)
- Being pregnant, nursing, and/or less than 9-months postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | EFNEP Group |
Primary outcome
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 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 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 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 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 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 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 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.
11 secondary outcomes
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
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
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
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
Participant Demographics Baseline
Time frame: Baseline.
Participant Demographics Post Intervention
Time frame: Immediately Post Intervention.
Participant Demographics 6 Months Post Intervention
Time frame: 6 Months Post Intervention
Participant Demographics 12 Months Post Intervention
Time frame: 12 Months Post Intervention
Participant Health Status Baseline
Time frame: Baseline
Participant Health Status 6 Months Post Intervention
Time frame: 6 Months Post Intervention
Participant Health Status 12 Months Post Intervention
Time frame: 12 Months Post Intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Yes. Deidentified participant data will be made available on South Dakota State University's Open Access Institutional Repository, Open PRAIRIE.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expanded Food and Nutrition Education Program (EFNEP) in people with Chronic Disease, run by South Dakota State University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea M Leschewski, PhD (517-927-3487, andrea.leschewski@sdstate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Height from Baseline to 6 Months Post Intervention (time frame: Change in height measurement from baseline to 6 months post intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.