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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the Culturally Tailored Diabetes Prevention Program treatment?

Research shows that culturally tailored Diabetes Prevention Programs (DPP) can effectively reduce diabetes risk in diverse communities, such as Chinese Americans and Latinos, by adapting the program to fit cultural and linguistic needs. These adaptations have been successful in helping people achieve goals like increased physical activity and weight loss, which are important for preventing diabetes. ^{1 2 3 4 5}

Is the Culturally Tailored Diabetes Prevention Program safe for humans?

The Diabetes Prevention Program (DPP) and its culturally tailored versions have been widely implemented and studied, showing effectiveness in reducing diabetes risk through lifestyle changes like healthy eating and physical activity. While the studies focus on effectiveness, they do not report any safety concerns, suggesting that the program is generally safe for humans. ^{1 2 4 6 7}

What makes the Culturally Tailored Diabetes Prevention Program unique compared to other treatments for prediabetes?

The Culturally Tailored Diabetes Prevention Program is unique because it adapts the standard Diabetes Prevention Program to fit the cultural and linguistic needs of specific communities, such as Chinese Americans and Latinos, making it more effective in reducing diabetes risk in these groups. ^{1 2 4 6 8}

Research Team

Jannette Y Berkley-Patton, PhD

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 (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]

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) 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adaptation of diabetes prevention program for Chinese Americans - a qualitative study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A Latino Patient-Centered, Evidence-Based Approach to Diabetes Prevention. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The role of Sociodemographic factors on goal achievement in a community-based diabetes prevention program behavioral lifestyle intervention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Program Modification Strategies of the Diabetes Prevention Program: A Systematic Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A review of diabetes prevention program translations: use of cultural adaptation and implementation research. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Recruitment for a Diabetes Prevention Program translation effort in a worksite setting. [2022]

7. United States 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]