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RecruitingNCT05301413FIT4ALLUpdated May 25, 2025

Social Determinants and a Diabetes Prevention Program Tailored for African Americans

A Phase 2 interventional study of Culturally Tailored Diabetes Prevention Program and Culturally Tailored DPP Enhanced with Socioeconomic Supports in PreDiabetes and Overweight and Obesity, sponsored by University of Missouri, Kansas City. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by University of Missouri, Kansas City · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

African Americans (AAs) are disproportionately burdened by diabetes mellitus (DM) with rates twice as high as Whites (13% vs 7.5%), and increased rates of DM-related complications and comorbidities (e.g. amputations, cardiovascular disease). A key pre-DM risk factor is overweight/obesity. Nearly 70% of AAs are overweight or obese, with higher rates among AAs with low-income. A critical component of national efforts to reduce growing obesity rates and prevent DM is the Diabetes Prevention Program (DPP), a lifestyle intervention proven to reduce or delay DM onset with diet change, exercise, and modest weight loss (5-7%) in a rigorously evaluated national trial. A group-based version of the DPP has been widely disseminated and numerous community-based trials support its efficacy. In spite of these successes, there are significant health disparities in DPP attendance and outcomes and considerable room exists for improving success rates among AAs, a population that tends to experience half the amount of DPP weight loss compared to Whites. The investigators aim to build on our promising pilot studies by tailoring the DPP via a social determinants (SD) of health lens to achieve optimal DPP attendance and clinically meaningful weight loss with pre-DM AAs. This includes tailoring on cultural and socioeconomic SD mechanisms that are associated with improving health outcomes and align with predisposing needs among AAs who are primarily of low-income and live in low-resource AA communities.

The investigators propose a randomized controlled trial of 360 pre-DM AA patients from a safety net hospital (SNH) to test a standard DPP (S-DPP) against a culturally tailored DPP (TC-DPP; e.g., tailoring of language, foods, values, religiosity, norms, values) alone and a culturally tailored DPP enhanced to address access and support related economic barriers (TCE-DPP; hybrid group/online/text DPP; community health worker support to improve access to DPP classes, healthy food, exercise, and other community and health resources; and class promotions) over 12 months. The investigators will: 1) examine effects of TC-DPP and TCE-DDP on percent weight loss and attendance (primary outcomes) and on secondary outcomes (physical activity, completion of physician follow-up visit, hbA1c, and blood pressure) at 6 and 12 months with SNH AAs, 2) evaluate potential mediators/ moderators related to weight loss and attendance among AA SNH patients at 6 and 12 months to determine modifiable facilitators and barriers, and 3) conduct a process evaluation to examine TCE-DPP acceptability, feasibility, and fidelity, and relationships between delivery dose, exposure, costs, and outcomes to identify and improve essential intervention components. Our multidimensional DPP interventions are guided by our past pilots, and based on components that, all together, were used to help drive clinically important outcomes in the original DPP trial - and are certainly needed to achieve similar outcomes with AA primarily of low-income. To our knowledge this is the first study to test multidimensional tailoring via an SD lens to truly impact DPP attendance and outcomes, and has potential to be a feasible, scalable model to reduce DM disparities among at-risk AA.

02

Conditions studied

  • PreDiabetes
  • Overweight and Obesity

Keywords

  • African American
  • Prediabetes
  • Diabetes Prevention Program
  • Cultural tailoring
  • Linkage to care
  • Weight loss
  • Class attendance
03

In context

Prediabetic State

918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.

This study's planned enrollment of 360 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

University of Missouri, Kansas City is the lead sponsor of 48 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Black/African American
  • Overweight ([> 24); and
  • Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Active comparator
    Standard

    Standard Diabetes Prevention Program (DPP)

    Behavioral: Diabetes Prevention Program

  • Experimental
    Culturally Tailored DPP

    DPP culturally tailored for African Americans

    Behavioral: Culturally Tailored Diabetes Prevention Program · Behavioral: Diabetes Prevention Program

  • Experimental
    Culturally Tailored DPP Enhanced with Socioeconomic Supports

    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

    Behavioral: Culturally Tailored Diabetes Prevention Program · Behavioral: Culturally Tailored DPP Enhanced with Socioeconomic Supports · Behavioral: Diabetes Prevention Program

Interventions

  • BehavioralCulturally Tailored Diabetes Prevention Program

    This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts

    Also known as: Culturally Tailored DPP

  • BehavioralCulturally 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

    Also known as: FIT4ALL

  • BehavioralDiabetes Prevention Program

    This is the CDC TD2 evidence-based Diabetes Prevention Program

    Also known as: DPP

06

What researchers measure

Primary outcomes

  1. Percent Weight Loss

    Percentage of weight loss from initial baseline weight

    Time frame: 6 months

  2. Percent Weight Loss

    Percentage of weight loss from initial baseline weight

    Time frame: 12 months

  3. DPP Class Attendance

    Number and proportion of the classes attended

    Time frame: 6 months

  4. DPP Class Attendance

    Number and proportion of the classes attended

    Time frame: 12 months

Secondary outcomes

  1. Physical Activity

    Self-reported hours/minutes of physical activity in past week

    Time frame: 6 months

  2. Physical Activity

    Self-reported hours/minutes of physical activity in past week

    Time frame: 12 months

  3. Blood pressure

    Systolic and diastolic blood pressure will be measured

    Time frame: 6 months

  4. Blood pressure

    Systolic and diastolic blood pressure will be measured

    Time frame: 12 months

  5. Blood glucose

    Hemoglobin A1C

    Time frame: 6 months

  6. Blood glucose

    Hemoglobin A1C

    Time frame: 12 months

  7. Office/clinic visits

    Proportion of participants with a physician office/clinic visit

    Time frame: 12 months

07

Study locations

1 of 2 sites recruiting
  • University Health
    Kansas City, Missouri 64108, United States
    Not yet recruiting
    • Betty Drees, M.D. · Contactdreesb@umkc.edu · 816-404-4070
    • Betty Drees · Sub investigator
  • University of Missouri-Kansas City
    Kansas City, Missouri 64108, United States
    Recruiting
    • Jannette Berkley-Patton, PhD · Contact816-235-6362
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05301413
Lead sponsor
University of Missouri, Kansas City
Collaborators
University of Massachusetts, Amherst, University of Kansas, Children's Mercy Hospital Kansas City, University Health
Responsible party
Jannette Berkley-Patton (Professor, University of Missouri, Kansas City) — Principal investigator
First posted
Mar 29, 2022
Start date
Jul 20, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
May 25, 2025

Study contacts

Christopher Winders
Contact
windersc@umkc.edu
18162355370
Carole Bowe Thompson
Contact
bowethompsonc@umkc.edu
8162356062
Jannette Y Berkley-Patton, PhD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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