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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

Must not have

Diagnosed with diabetes

Had heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with diabetes.

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I have had heart failure.

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I had weight loss surgery in the past year.

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I am experiencing significant weight loss due to a medical condition.

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I am not willing to use a fitness tracker, wi-fi scale, or the internet.

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I am not fluent in English.

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I can't walk a short distance without help because of chest pain or discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DPP Class Attendance

Percent Weight Loss

Secondary study objectives

Blood glucose

Blood pressure

Office/clinic visits

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~940