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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Culturally Tailored Diabetes Prevention Program
BehavioralThis intervention includes a culturally tailored DPP curriculum, class procedures, and handouts
Culturally Tailored DPP Enhanced with Socioeconomic Supports
BehavioralThis 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
BehavioralThis is the CDC TD2 evidence-based Diabetes Prevention Program
Treatment groups
Trial outcomes
Primary outcomes
Percent Weight Loss
Percentage of weight loss from initial baseline weight
Percent Weight Loss
Percentage of weight loss from initial baseline weight
DPP Class Attendance
Number and proportion of the classes attended
DPP Class Attendance
Number and proportion of the classes attended
Secondary outcomes
Physical Activity
Self-reported hours/minutes of physical activity in past week
Physical Activity
Self-reported hours/minutes of physical activity in past week
Blood pressure
Systolic and diastolic blood pressure will be measured
Blood pressure
Systolic and diastolic blood pressure will be measured
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