Culturally Tailored Diabetes Prevention for Prediabetes

(FIT4ALL Trial)

Recruiting at 1 trial location

Overseen By Carole Bowe Thompson

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Missouri, Kansas City

Disqualifiers: Diabetes, Pregnant, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to prevent Type 2 diabetes, focusing on African Americans who face a higher risk. It evaluates three programs: the standard Diabetes Prevention Program (DPP), a culturally tailored version for African Americans, and an enhanced version that includes support for overcoming socioeconomic challenges. The goal is to determine which program best aids in maintaining healthy habits and losing weight. This trial suits African Americans who are overweight and have been diagnosed with prediabetes or are at high risk. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Diabetes Prevention Program (DPP) can significantly reduce the risk of developing type 2 diabetes. This program emphasizes lifestyle changes such as improving diet, increasing exercise, and losing weight. Studies have found that versions of the DPP adapted to specific cultural needs and preferences are also effective. Specifically, 74% of these culturally adapted studies reported better blood sugar levels and other health improvements.

The culturally tailored DPP, which includes support for economic challenges, aims to boost participation and success by addressing issues like income and access to resources. Although this specific approach is new, adapting programs to meet cultural and economic needs is a promising strategy.

While the trial is in its early stages, resulting in limited safety data, the DPP itself is well-established and generally safe. It has been widely used without reports of serious side effects. Participants can feel confident that the approach is based on a proven model, and the tailored changes are designed to enhance its effectiveness without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these diabetes prevention methods because they are culturally tailored, specifically for African Americans, making them more relatable and potentially more effective. Unlike the standard Diabetes Prevention Program (DPP), these programs incorporate cultural nuances and, in one arm, also include socioeconomic supports like class attendance incentives and community health worker assistance. This approach not only respects cultural differences but also addresses social barriers, which could lead to better engagement and outcomes in preventing diabetes.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that diabetes prevention programs tailored to cultural needs can significantly improve health measures like blood sugar levels. Notably, 74% of studies with these culturally tailored programs have reported such improvements. Furthermore, lifestyle changes in these programs have led to a 58% reduction in diabetes rates among participants. In this trial, participants may join the Culturally Tailored Diabetes Prevention Program, specifically designed for African Americans, or the Culturally Tailored DPP Enhanced with Socioeconomic Supports. The enhanced program provides additional support to address challenges such as attending classes, offering a combination of in-person and online sessions, and assistance from community health workers, making it more accessible and effective for those facing economic difficulties. ^{1 3 4 6 7}

Who Is on the Research Team?

Jannette Y Berkley-Patton, PhD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Black/African American

You weigh more than what is considered healthy for your height.

I have been diagnosed with prediabetes, had gestational diabetes, or am at high risk for prediabetes.

Exclusion Criteria

I have been diagnosed with diabetes.

You are currently in a program to lose weight.

I have had heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a standard DPP, a culturally tailored DPP, or a culturally tailored DPP enhanced with socioeconomic supports over 12 months

12 months

Hybrid attendance (in-person and virtual)

Follow-up

Participants are monitored for weight loss, physical activity, and other health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Culturally Tailored Diabetes Prevention Program
• Culturally Tailored DPP Enhanced with Socioeconomic Supports
• Diabetes Prevention Program

Trial Overview 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.

How Is the Trial Designed?

Group I: Culturally Tailored DPP Enhanced with Socioeconomic Supports Experimental Treatment 3 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 DPP Experimental Treatment 2 Interventions

DPP culturally tailored for African Americans

Group III: Standard Active Control 1 Intervention

Standard Diabetes Prevention Program (DPP)

Culturally Tailored Diabetes Prevention Program is already approved in United States for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

University Health

Collaborator

Trials

2

Recruited

560+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Children's Mercy Hospital Kansas City

Collaborator

Trials

261

Recruited

941,000+

Published Research Related to This Trial

A two-stage formative research process involving 34 Latino patients and 5 healthcare stakeholders successfully adapted a diabetes prevention program to better fit the cultural values of the Latino community, emphasizing family and community support.

Key adaptations included inviting family members to sessions, using smartphone applications for support, and providing culturally appropriate meals, which enhanced the intervention's relevance and potential effectiveness in promoting behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Latino Patient-Centered, Evidence-Based Approach to Diabetes Prevention. Rosas, LG., Lv, N., Lewis, MA., et al.[2021]

The study reviewed 28 interventions related to the Diabetes Prevention Program (DPP) and found that various cultural adaptations did not significantly impact weight or BMI reduction outcomes, suggesting the DPP is robust to these modifications.

Programs that included a maintenance component showed significantly greater weight reduction over time, highlighting the importance of ongoing support in reducing the risk of developing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. Neamah, HH., Sebert Kuhlmann, AK., Tabak, RG.[2022]

The Diabetes Prevention Program translated into the Group Lifestyle Balance (DPP-GLB) was effective in promoting significant weight loss among participants, but non-Hispanic white individuals lost more weight than non-Hispanic black participants at both 6 and 12 months, indicating a disparity in outcomes based on race/ethnicity.

While the program initially helped reduce disparities in physical activity levels, differences in achieving activity goals re-emerged after 12 months, highlighting the need for tailored interventions to better support marginalized groups in maintaining behavioral goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. Devaraj, SM., Napoleone, JM., Miller, RG., et al.[2022]

A culturally tailored online Diabetes Prevention Program (DPP) is highly acceptable among Chinese Americans with prediabetes in New York City, as indicated by focus group discussions involving 24 participants.

Key barriers to participation include limited internet access and low technology self-efficacy among older adults, highlighting the need for additional support and resources to facilitate engagement with the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of diabetes prevention program for Chinese Americans - a qualitative study. Yeh, MC., Lau, W., Chen, S., et al.[2023]

A successful recruitment plan for a Diabetes Prevention Program (DPP) lifestyle intervention at a corporate worksite led to the enrollment of 89 eligible participants out of 176 screened, demonstrating the feasibility of implementing such programs in workplace settings.

Key factors for effective recruitment included strong support from worksite leadership, a dedicated planning team, and the use of diverse media and in-person activities to engage potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment for a Diabetes Prevention Program translation effort in a worksite setting. Taradash, J., Kramer, M., Molenaar, D., et al.[2022]

The Diabetes Prevention Program (DPP) effectively prevents type 2 diabetes through lifestyle changes, and this study reviewed 44 original studies on how to adapt and implement the DPP in various cultural contexts.

Cultural adaptations were most often related to content, and the program was frequently shortened and delivered in group formats, highlighting the importance of tailoring the DPP to different populations for better adoption and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of diabetes prevention program translations: use of cultural adaptation and implementation research. Tabak, RG., Sinclair, KA., Baumann, AA., et al.[2022]

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

The Diabetes Prevention Program (DPP) showed that individuals with prediabetes could lower their risk of developing type 2 diabetes by 58% through a combination of 5%-7% weight loss, healthy eating, and increased physical activity.

A pilot adaptation of the National DPP specifically targeting men from low-income and minority communities was developed, emphasizing male-only groups and coaches, which was informed by input from community leaders and focus groups to enhance participation and address barriers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of the National Diabetes Prevention Program to Engage Men in Disadvantaged Neighborhoods in New York City: A Description of Power Up for Health. Gary-Webb, TL., Walker, EA., Realmuto, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05301413

Social Determinants and a Diabetes Prevention Program ... 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 ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/378256

Social Determinants and a Diabetes Prevention Program ... This novel study is the first to tailor the DPP to address SD cultural and socioeconomic barriers that limit DPP attendance and reduce its ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5408505/

Culturally Targeted Strategies for Diabetes Prevention in ... Twenty-five out of 34 studies (74%) that used cultural tailoring demonstrated significantly improved Hemoglobin A1C, fasting glucose, and/or ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11335425/

Delivering the National Diabetes Prevention Program Overall, the National DPP LCP was effective in helping many participants achieve program goals across demographic groups and delivery modes. We ...

5. cms.gov cms.gov/files/document/culturally-and-linguistically-tailored-type-2-diabetes-prevention-resource.pdf

Diabetes Prevention Programs: Equity Tailored Resources Main outcomes included weight, body mass index (BMI), blood pressure (BP), physical activity (PA), diet, and health self-efficacy. o T he intervention curricula ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/378256

Social Determinants and a Diabetes Prevention Program ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883766/

Culturally tailored lifestyle interventions for the prevention and ... This evidence supports the effectiveness of culturally tailored lifestyle interventions for T2D management in populations of Black African ancestry.