PreDiabetesPhase 2FIT4ALLNCT05301413
Social Determinants and a Diabetes Prevention Program Tailored for African Americans
A Phase 2 study testing Culturally Tailored Diabetes Prevention Program, Culturally Tailored DPP Enhanced with Socioeconomic Supports and Diabetes Prevention Program in people with PreDiabetes and Overweight and Obesity, run by University of Missouri, Kansas City at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Overweight and Obesity
- What is being tested?
- Culturally Tailored Diabetes Prevention Program, Culturally Tailored DPP Enhanced with Socioeconomic Supports and Diabetes Prevention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2022to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Black/African American
- Overweight ([BMI> 24); and
- Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
University Health
Kansas City, Missouri, 64108
Betty Drees, M.D., 816-404-4070, dreesb@umkc.edu
Betty Drees
- Recruiting
University of Missouri-Kansas City
Kansas City, Missouri, 64108
Jannette Berkley-Patton, PhD, 816-235-6362
About this study
Official title: Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)
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.
- Conditions
- PreDiabetes, Overweight and Obesity
- Being tested
- Culturally Tailored Diabetes Prevention Program, Culturally Tailored DPP Enhanced with Socioeconomic Supports, Diabetes Prevention Program
- Keywords
- African American, Prediabetes, Diabetes Prevention Program, Cultural tailoring, Linkage to care, Weight loss, Class attendance
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Tailored Diabetes Prevention ProgramBehavioural
Also called Culturally Tailored DPP
This intervention includes a culturally tailored DPP curriculum, class procedures, and handouts
Culturally Tailored DPP Enhanced with Socioeconomic SupportsBehavioural
Also called FIT4ALL
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
Diabetes Prevention ProgramBehavioural
Also called DPP
This is the CDC TD2 evidence-based Diabetes Prevention Program
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Standard Diabetes Prevention Program (DPP) Receives: Behavioral: Diabetes Prevention Program |
| Culturally Tailored DPP | Experimental | DPP culturally tailored for African Americans Receives: Behavioral: Culturally Tailored Diabetes Prevention Program; Behavioral: Diabetes Prevention Program |
| Culturally Tailored DPP Enhanced with Socioeconomic Supports | Experimental | 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 Receives: Behavioral: Culturally Tailored Diabetes Prevention Program; Behavioral: Culturally Tailored DPP Enhanced with Socioeconomic Supports; Behavioral: Diabetes Prevention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Loss
Percentage of weight loss from initial baseline weight
Measured: 6 months
Percent Weight Loss
Percentage of weight loss from initial baseline weight
Measured: 12 months
DPP Class Attendance
Number and proportion of the classes attended
Measured: 6 months
DPP Class Attendance
Number and proportion of the classes attended
Measured: 12 months
Secondary outcomes (7)
Physical Activity
Self-reported hours/minutes of physical activity in past week
Measured: 6 months
Physical Activity
Self-reported hours/minutes of physical activity in past week
Measured: 12 months
Blood pressure
Systolic and diastolic blood pressure will be measured
Measured: 6 months
Blood pressure
Systolic and diastolic blood pressure will be measured
Measured: 12 months
Blood glucose
Hemoglobin A1C
Measured: 6 months
Blood glucose
Hemoglobin A1C
Measured: 12 months
Office/clinic visits
Proportion of participants with a physician office/clinic visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start20 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Massachusetts, Amherst, University of Kansas, Children's Mercy Hospital Kansas City, University Health
- Responsible party
- Principal investigator, Jannette Berkley-Patton, University of Missouri, Kansas City
- Investigators
- Jannette Y Berkley-Patton, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301413
- Sponsor's protocol ID
- 2048442
- Acronym
- FIT4ALL
- Status last verified
- May 2025
- First submitted
- 9 Mar 2022
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Determinants of Health to Improve Diabetes Prevention Program Outcomes Among Underserved African Americans (FIT4ALL Project)
- ClinicalTrials.gov ID
- NCT05301413
- Acronym / sponsor ID
- FIT4ALL / 2048442
- Conditions
- PreDiabetes, Overweight and Obesity
- Keywords
- African American, Prediabetes, Diabetes Prevention Program, Cultural tailoring, Linkage to care, Weight loss, Class attendance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Collaborators
- University of Massachusetts, Amherst, University of Kansas, Children's Mercy Hospital Kansas City, University Health
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Diabetes Prevention ProgramStandard Diabetes Prevention Program (DPP) |
| Culturally Tailored DPP | Experimental | Behavioral: Culturally Tailored Diabetes Prevention Program, Behavioral: Diabetes Prevention ProgramDPP culturally tailored for African Americans |
| Culturally Tailored DPP Enhanced with Socioeconomic Supports | Experimental | Behavioral: Culturally Tailored Diabetes Prevention Program, Behavioral: Culturally Tailored DPP Enhanced with Socioeconomic Supports, Behavioral: Diabetes Prevention ProgramCulturally tailored DPP plus promotions for class attendance, hybrid attendance (in-person and virtual), and linkage to care services provided by a community health worker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Black/African American
- Overweight ([BMI> 24); and
- Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Tailored Diabetes Prevention ProgramAlso: Culturally Tailored DPPThis intervention includes a culturally tailored DPP curriculum, class procedures, and handouts | Behavioural | Culturally Tailored DPP, Culturally Tailored DPP Enhanced with Socioeconomic Supports |
| Culturally Tailored DPP Enhanced with Socioeconomic SupportsAlso: FIT4ALLThis 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 | Behavioural | Culturally Tailored DPP Enhanced with Socioeconomic Supports |
| Diabetes Prevention ProgramAlso: DPPThis is the CDC TD2 evidence-based Diabetes Prevention Program | Behavioural | Culturally Tailored DPP, Culturally Tailored DPP Enhanced with Socioeconomic Supports, Standard |
Primary outcome
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
7 secondary outcomes
Physical Activity
Time frame: 6 months
Physical Activity
Time frame: 12 months
Blood pressure
Time frame: 6 months
Blood pressure
Time frame: 12 months
Blood glucose
Time frame: 6 months
Blood glucose
Time frame: 12 months
Office/clinic visits
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jannette Y Berkley-Patton, PhD principal investigator
University of Missouri-Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Culturally Tailored Diabetes Prevention Program, Culturally Tailored DPP Enhanced with Socioeconomic Supports and Diabetes Prevention Program in people with PreDiabetes and Overweight and Obesity, run by University of Missouri, Kansas City at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Winders (18162355370, windersc@umkc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Loss (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.