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Behavioral Intervention
vDPP with Community Coordination for Diabetes Prevention
N/A
Waitlist Available
Led By Rafael Perez-Escamilla, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks and 12 months
Awards & highlights
Study Summary
This trial will study if a diabetes prevention program delivered online by community health workers and nurses can help low-income people at risk for type 2 diabetes improve their health.
Who is the study for?
This trial is for low-income individuals at risk for type 2 diabetes who are eligible for Medicaid in Connecticut, specifically from Derby, Ansonia, or New Haven's ECC communities. Participants must have a BMI of 25 or higher and score at least 5 on the CDC prediabetes risk test. Exclusions include non-English speakers, pregnant women or those planning pregnancy soon, diagnosed diabetics, inability to exercise, eating disorders.Check my eligibility
What is being tested?
The study tests a virtual Diabetes Prevention Program (vDPP) supported by community health workers and hospital-based nurses aimed at improving weight, blood pressure, diet quality and physical activity among those at risk of developing type 2 diabetes.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes rather than medication there may not be direct side effects; however participants might experience discomfort adjusting to new diet/exercise routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in BMI
Secondary outcome measures
Change in Diet Quality
Change in High-density Lipoprotein
Change in Physical Activity
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: vDPP Full StudyExperimental Treatment1 Intervention
Participants will take part in a 52 week study receiving the vDPP intervention.
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Who is running the clinical trial?
Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,293 Total Patients Enrolled
Centers for Disease Control and PreventionFED
873 Previous Clinical Trials
22,467,460 Total Patients Enrolled
Rafael Perez-Escamilla, PhDPrincipal InvestigatorProfessor of Public Health, Director of the Office of Public Health Practice, and Director of the Global Health Concentration at the Yale School of Public Health
1 Previous Clinical Trials
249 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My score on the CDC prediabetes test is 5 or higher.You currently have an eating disorder and have reported it yourself.I have been diagnosed with type 1 or type 2 diabetes.I do not speak English.You are unable to participate in physical activities or exercise.
Research Study Groups:
This trial has the following groups:- Group 1: vDPP Full Study
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are taking part in this research endeavor?
"Affirmative. Clinicaltrials website states that this medical study, which was launched on October 7th 2020, is actively searching for volunteers. Approximately 120 patients need to be sourced from two separate healthcare facilities."
Answered by AI
Are there any opportunities for patients to enrol in this experiment?
"According to clinicaltrials.gov, this research is still actively searching for participants. It was initially posted on October 7th 2020 and its most recent update occurred August 11th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Griffin Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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