NCT05301413 · University of Missouri, Kansas City
Social Determinants and a Diabetes Prevention Program Tailored for African Americans
(FIT4ALL)
What this study is about
African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income.
View original scientific description
African Americans (AAs) have rates of diabetes mellitus (DM) twice that of Whites and are disproportionately affected by leading risk factors for DM - obesity and low-income. A critical strategy in the battle against DM is the Diabetes Prevention Program (DPP), an evidence-based intervention that significantly delays or prevents Type 2 diabetes through the promotion of diet change, exercise and modest weight loss.
Interventions
BEHAVIORAL
Culturally Tailored Diabetes Prevention Program
This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts
BEHAVIORAL
Culturally Tailored DPP Enhanced with Socioeconomic Supports
This intervention includes the culturally tailored DPP curriculum, class procedures, and handouts along with promotional items for class participation, opportunities to attend class in-person or virtually through a digital platform, and assistance from a community health worker to provide linkage to health care services and community resources
BEHAVIORAL
Diabetes Prevention Program
This is the CDC TD2 evidence-based Diabetes Prevention Program
Primary outcome measures
Percent Weight Loss
Time frame: 6 months
Percentage of weight loss from initial baseline weight
Percent Weight Loss
Time frame: 12 months
Percentage of weight loss from initial baseline weight
DPP Class Attendance
Time frame: 6 months
Number and proportion of the classes attended
DPP Class Attendance
Time frame: 12 months
Number and proportion of the classes attended
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Black/African American
- Overweight (\[BMI\> 24); and
- Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Exclusion criteria
- Diagnosed with diabetes
- Not fluent in English
- Currently pregnant, planning a pregnancy in the next year, currently breastfeeding or have given birth in the last 6 months
- Currently participating in a weight loss program
- Currently have a medical condition that causes drastic weight loss
- Bariatric weight loss surgery in last year
- Cannot walk a 1-block distance without assistance and without stopping due to pain, tightness, or pressure in the chest
- Had heart failure
- Not willing to use a fitness tracker, wi-fi scale, and the internet
- Not available in the evening one day each week to participate in a class
Where
- Kansas City, Missouri
Collaborators
University of Massachusetts, Amherst, University of Kansas, Children's Mercy Hospital Kansas City, University Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 25, 2025 · Source of record for eligibility and locations