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NCT07560969
Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans
Conditions: Diabetes, Physical Activity, Food Security, Nutrition Security
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 408
Sponsor: University of Missouri, Kansas City
Location: University of Missouri-Kansas City Kansas City Missouri
Summary
The goal of this clinical trial is to learn if an enhanced, culturally, socially, and structurally tailored Diabetes Prevention Program (E-DPP) can improve weight loss and related diabetes risk factors in African American adults with prediabetes living in low-income, socially vulnerable communities.
The main questions it aims to answer are:
* Does the enhanced DPP (E-DPP) lead to greater percent weight loss at 6 and 12 months compared to the standard culturally tailored DPP (S-DPP)?
* How do social determinants (e.g., food insecurity, stigma, access to resources) influence weight loss and engagement in lifestyle behaviors?
Researchers will compare a standard culturally tailored DPP (S-DPP) to an enhanced DPP (E-DPP) to see if improving access to healthy food, physical activity, and community resources increases weight loss and improves diabetes-related outcomes.
Participants will
1. Attend DPP sessions delivered in community settings (e.g., churches)
2. Receive lifestyle education focused on diet, physical activity, and weight loss
3. Engage in physical activity (including in-class exercise sessions \[E-DPP only\] and community-based options)
4. Receive support for healthy eating, including food deliveries (\[E-DPP only\]), food selection guidance, and referrals to food assistance programs
5. Receive information and support for accessing community resources for food and physical activity
Eligibility Criteria
Inclusion Criteria:
* Members of a participating church or user of a participating church's outreach services
* Age 18 years or older
* Prediabetic (score of 5 or higher in the National Diabetes Prevention Program Risk Score or (\[body mass index \> 24 or history of gestational diabetes\] and (5.7-6.4 A1v, 100-125 mg/dL fasting plasma glucose, or 140-149 mg/dL oral glucose tolerance test)
Exclusion Criteria:
* Individuals who are pregnant, breastfeeding or planning to become pregnant in the next year
* Individuals with unsafe blood pressure levels (160 systolic or higher or 100 diastolic or higher) without a medical clearance firn
* Individuals who are not able to engage in low-impact physical activity
* Individuals who do not speak English
* Individuals who live in a household with a participant in this study at a different church
Source: ClinicalTrials.gov (NCT07560969). StuddyBuddy aggregates publicly available trial information.