Social Determinants and a Diabetes Prevention Program Tailored for African Americans
FIT4ALL
Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)
1 other identifier
interventional
360
1 country
2
Brief Summary
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. However, weight loss from the DPP among AAs is about half that of White participants, and suboptimal AA attendance is a critical contributor. The investigators propose to conduct a study that will address social determinants (SD) that challenge DPP attendance with underserved African Americans from a safety net hospital. The investigators will examine DPP attendance and weight loss with participants randomized to 3 groups: standard DPP, a culturally-tailored DPP to address acceptability, and a culturally-tailored DPP enhanced to address socioeconomic-related barriers to DPP participation. This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its effectiveness on outcomes. The proposed multidimensional, SD tailored DPP has great potential to be a feasible and scalable model to reduce DM risks among urban, African Americans and ultimately reduce DM disparities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2022
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedStudy Start
First participant enrolled
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMay 25, 2025
May 1, 2025
3.5 years
March 9, 2022
May 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percent Weight Loss
Percentage of weight loss from initial baseline weight
6 months
Percent Weight Loss
Percentage of weight loss from initial baseline weight
12 months
DPP Class Attendance
Number and proportion of the classes attended
6 months
DPP Class Attendance
Number and proportion of the classes attended
12 months
Secondary Outcomes (7)
Physical Activity
6 months
Physical Activity
12 months
Blood pressure
6 months
Blood pressure
12 months
Blood glucose
6 months
- +2 more secondary outcomes
Study Arms (3)
Standard
ACTIVE COMPARATORStandard Diabetes Prevention Program (DPP)
Culturally Tailored DPP
EXPERIMENTALDPP culturally tailored for African Americans
Culturally Tailored DPP Enhanced with Socioeconomic Supports
EXPERIMENTALCulturally tailored DPP plus promotions for class attendance, hybrid attendance (in-person and virtual), and linkage to care services provided by a community health worker
Interventions
This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts
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
This is the CDC TD2 evidence-based Diabetes Prevention Program
Eligibility Criteria
You may qualify if:
- Black/African American
- Overweight (\[BMI\> 24); and
- Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
You may not qualify if:
- Diagnosed with diabetes
- Pregnant
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Missouri, Kansas Citylead
- University of Massachusetts, Amherstcollaborator
- University of Kansascollaborator
- Children's Mercy Hospital Kansas Citycollaborator
- University Healthcollaborator
Study Sites (2)
University Health
Kansas City, Missouri, 64108, United States
University of Missouri-Kansas City
Kansas City, Missouri, 64108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jannette Y Berkley-Patton, PhD
University of Missouri-Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 9, 2022
First Posted
March 29, 2022
Study Start
July 20, 2022
Primary Completion
December 31, 2025
Study Completion
February 28, 2026
Last Updated
May 25, 2025
Record last verified: 2025-05