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Behavioral Intervention
Culturally Tailored Diabetes Prevention for Prediabetes (FIT4ALL Trial)
Phase 2
Recruiting
Led By Jannette Y Berkley-Patton, PhD
Research Sponsored by University of Missouri, Kansas City
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 12 months
Awards & highlights
FIT4ALL Trial Summary
This trial will study whether a culturally-tailored diabetes prevention program can help African Americans who are at risk for diabetes by addressing social determinants that make it difficult for them to attend the program.
Who is the study for?
This trial is for African Americans who are overweight (BMI > 24) and have prediabetes, a history of gestational diabetes, or a high risk for prediabetes. It's not open to those who are pregnant, non-English speakers, diagnosed with diabetes, planning pregnancy soon, currently in another weight loss program or have certain medical conditions.Check my eligibility
What is being tested?
The study tests three approaches to prevent diabetes: a standard Diabetes Prevention Program (DPP), a culturally tailored DPP for African Americans' acceptability issues, and an enhanced version addressing socioeconomic barriers that affect participation.See study design
What are the potential side effects?
Since this trial focuses on lifestyle changes like diet and exercise rather than medication, side effects may include muscle soreness from new physical activities or dietary adjustments but no drug-related side effects.
FIT4ALL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DPP Class Attendance
Percent Weight Loss
Secondary outcome measures
Blood glucose
Blood pressure
Office/clinic visits
+1 moreFIT4ALL Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Culturally Tailored DPP Enhanced with Socioeconomic SupportsExperimental Treatment3 Interventions
Culturally tailored DPP plus promotions for class attendance, hybrid attendance (in-person and virtual), and linkage to care services provided by a community health worker
Group II: Culturally Tailored DPPExperimental Treatment2 Interventions
DPP culturally tailored for African Americans
Group III: StandardActive Control1 Intervention
Standard Diabetes Prevention Program (DPP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes Prevention Program
2018
Completed Phase 2
~890
Find a Location
Who is running the clinical trial?
University of Missouri, Kansas CityLead Sponsor
69 Previous Clinical Trials
32,284 Total Patients Enrolled
University HealthUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
University of KansasOTHER
147 Previous Clinical Trials
325,501 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diabetes.You are currently in a program to lose weight.I have had heart failure.I had weight loss surgery in the past year.I am experiencing significant weight loss due to a medical condition.You weigh more than what is considered healthy for your height.I am not willing to use a fitness tracker, wi-fi scale, or the internet.I have been diagnosed with prediabetes, had gestational diabetes, or am at high risk for prediabetes.I am not fluent in English.You are heavier than what is considered healthy for your height.I can't walk a short distance without help because of chest pain or discomfort.You weigh more than the healthy range for your height.
Research Study Groups:
This trial has the following groups:- Group 1: Standard
- Group 2: Culturally Tailored DPP
- Group 3: Culturally Tailored DPP Enhanced with Socioeconomic Supports
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.
What is the governmental agency's stance on Diabetes Prevention Program?
"The Diabetes Prevention Program received a score of 2 for safety. In Phase 2 clinical trials there is some data supporting safety, but none yet demonstrating efficacy."
Answered by AI
Are patients being actively sought for this experiment?
"The clinical trial in question is not looking for any more participants at this time. This can be found on clinicaltrials.gov, where the study was first posted on April 1st, 2022 and last edited March 28th, 2022. There are still 560 other trials actively enrolling patients."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Kansas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Missouri-Kansas City
How many prior treatments have patients received?
0
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