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EFNEP for Chronic Disease

N/A
Recruiting
Research Sponsored by South Dakota State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in 24-hour dietary recalls baseline to 12 months post intervention
Awards & highlights

Study Summary

This trial will assess whether the EFNEP program is a cost-effective way to improve chronic disease biomarkers. 500 adults in four states will be monitored over the course of a year, measuring things like BMI, blood pressure, and HbA1c. The study will use analytical techniques like cost-benefit analysis and multivariate analysis.

Who is the study for?
This trial is for adults living with chronic diseases who have an income at or below 185% of the Federal Poverty Line. Participants must speak and understand English or Spanish, be free-living, and not currently pregnant, nursing, or less than 9-months postpartum.Check my eligibility
What is being tested?
The study tests if the Expanded Food and Nutrition Education Program (EFNEP) is cost-effective in improving health markers related to chronic disease. It will compare changes in BMI, blood pressure, and HbA1c levels before the program starts, then again at six months and one year after completion.See study design
What are the potential side effects?
Since EFNEP is a nutrition education intervention rather than a drug treatment, it does not have side effects like medications do. However, participants may experience lifestyle adjustments due to dietary changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in 24-hour dietary recalls baseline to 12 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and change in 24-hour dietary recalls baseline to 12 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in HbA1c from Baseline to 12 Months Post Intervention
Change in HbA1c from Baseline to 6 Months Post Intervention
Change in Height from Baseline to 12 Months Post Intervention
+5 more
Secondary outcome measures
Change in 24-Hour Dietary Recalls Baseline to 12 Months Post Intervention
Change in 24-Hour Dietary Recalls Baseline to 6 Months Post Intervention
Change in EFNEP Adult Questionnaire Responses Baseline to 12 Months Post Intervention
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EFNEP GroupExperimental Treatment1 Intervention
Subjects will receive the EFNEP Eat Smart Being Active class series.
Group II: Control GroupActive Control1 Intervention
Subjects will receive no EFNEP intervention.

Find a Location

Who is running the clinical trial?

University of FloridaOTHER
1,338 Previous Clinical Trials
714,856 Total Patients Enrolled
4 Trials studying Chronic Disease
63 Patients Enrolled for Chronic Disease
Colorado State UniversityOTHER
123 Previous Clinical Trials
37,504 Total Patients Enrolled
2 Trials studying Chronic Disease
326 Patients Enrolled for Chronic Disease
University of IdahoOTHER
19 Previous Clinical Trials
2,224 Total Patients Enrolled

Media Library

Expanded Food and Nutrition Education Program (EFNEP) Clinical Trial Eligibility Overview. Trial Name: NCT05558085 — N/A
Chronic Disease Research Study Groups: EFNEP Group, Control Group
Chronic Disease Clinical Trial 2023: Expanded Food and Nutrition Education Program (EFNEP) Highlights & Side Effects. Trial Name: NCT05558085 — N/A
Expanded Food and Nutrition Education Program (EFNEP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558085 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What results are researchers hoping to glean from this clinical exploration?

"This research project aims to measure changes in blood pressure from the baseline measurement up until 12 months after intervention. The secondary objectives will evaluate participant health status 6 months post-intervention via a specific questionnaire, alterations to EFNEP adult questionnaire responses over the same period of time, and pertinent demographic information at the conclusion of treatment."

Answered by AI

Is it possible to become a participant in this research experiment?

"This clinical trial is accepting 500 applicants, aged 18 to 50 with chronic illnesses. Additionally, they must be self-sufficient and bilingual in both English and Spanish. Eligible participants' income should fall below 185% of the Federal Poverty Line."

Answered by AI

How many healthcare facilities are conducting this experiment?

"Four clinical centres are offering this trial, including Washington State University in Pullman, University of Florida in Gainesville, and Colorado State University in Fort Collins. Additionally, another four medical sites are hosting the same study."

Answered by AI

Does this research have any age restrictions, particularly for those aged 55 and up?

"The parameters for participation in this trial are between 18 to 50 years old. There are separate studies available for participants under the age of 18, and those over 65."

Answered by AI

Are there openings available for participants of this experiment?

"Clinicaltrials.gov records that this investigation is actively searching for qualified applicants, the original posting of which was on September 26th 2022 and has recently been updated to October 3rd 2022."

Answered by AI

What is the aggregate of participants in this clinical experiment?

"This trial necessitates 500 qualified patients to partake. Those who decide to join can do so at Washington State University in Pullman, WA or the University of Florida in Gainesville, FL."

Answered by AI
~167 spots leftby Dec 2024