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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in 24-hour dietary recalls baseline to 12 months post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in 24-hour dietary recalls baseline to 12 months post intervention
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 moreSecondary 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 moreTrial 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
1,353 Previous Clinical Trials
723,010 Total Patients Enrolled
4 Trials studying Chronic Disease
63 Patients Enrolled for Chronic Disease
Colorado State UniversityOTHER
129 Previous Clinical Trials
37,741 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently breastfeeding.I can speak and understand either English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: EFNEP Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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