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Addressing Food Access and Physical Activity to Improve Diabetes Prevention Outcomes Among Underserved African Americans

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two diabetes prevention programs for African American adults with prediabetes in low-income communities with limited resources. Prediabetes means blood sugar is higher than normal but not high enough to be diabetes. Researchers want to see if adding food deliveries, exercise sessions, and community support helps people lose more weight and lower their diabetes risk.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a member of a participating church or use that church’s outreach services.
  • Be age 18 or older.
  • Have a National Diabetes Prevention Program risk score of 5 or higher; OR meet both the body size or pregnancy history requirement and the blood sugar requirement below.
  • For the second path: have a body mass index (BMI, a measure of weight compared with height) over 24, or have had diabetes during pregnancy.
  • For the second path: have an A1c (long-term blood sugar) of 5.7–6.4, fasting blood sugar of 100–125 mg/dL, or an oral glucose tolerance test result of 140–149 mg/dL.

Who can't join

  • Be pregnant, breastfeeding, or planning to become pregnant in the next year.
  • Have blood pressure with a top number of 160 or higher or a bottom number of 100 or higher, without a medical clearance form.
  • Be unable to do gentle, low-impact physical activity.
  • Not speak English.
  • Live with someone who is in this study at a different church.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

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