Social Determinants and a Diabetes Prevention Program Tailored for African Americans

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Missouri, Kansas City

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Black/African American

Overweight ([BMI> 24); and

Diagnosed with prediabetes OR pre-diagnosed with gestational diabetes OR high risk result on prediabetes risk test

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Culturally Tailored Diabetes Prevention Program

    Behavioral

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

  • Culturally Tailored DPP Enhanced with Socioeconomic Supports

    Behavioral

    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 Program

    Behavioral

    This is the CDC TD2 evidence-based Diabetes Prevention Program

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: StandardActive comparator 1 intervention
Group B: Culturally Tailored DPPExperimental treatment 2 interventions
Group C: Culturally Tailored DPP Enhanced with Socioeconomic SupportsExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Missouri, Kansas City

Lead sponsor

University of Massachusetts, Amherst

Collaborator

University of Kansas

Collaborator

Children's Mercy Hospital Kansas City

Collaborator

University Health

Collaborator