Status:
COMPLETED
Preventing Diabetes in the Deep South: Extending Partnerships and Adapting Interventions to Reach Rural Communities at High Risk.
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pre-diabetes
Eligibility:
All Genders
19-65 years
Phase:
NA
Brief Summary
Diabetes is responsible for a huge and growing burden of patient suffering and social costs, and the impact of this disease is shared disproportionately by minorities and in rural resource-challenged ...
Detailed Description
The pilot trial in aim three will include enrolling four primary care practices. Each of the participating practices will be randomized to one of two arms and accordingly enrolled participants from ea...
Eligibility Criteria
Inclusion
- Age 19 to 65 years
- Body mass index (BMI) ≥30
- Receives care at one of the participating primary care clinics
- HbA1c 6.0% to 6.4%
- Resides in one location at least 5 days each week
- Willing to attend group-based classes
- Willing to work with a peer advisor in-person and over the phone
- Has regular access to telephone or cellular phone
- Willing and able to use telemonitoring body weight to conduct daily self-weighing
- Estimated Glomerular Filtration Rate (eGFR) of ≥60 in their medical record within 6 months
Exclusion
- Diabetes diagnosis or HbA1c \>6.4% or fasting glucose ≥126
- HbA1c \<6.0%
- Pregnancy or anticipating pregnancy
- Unwilling or unable to do any of the following: give informed consent, accept random assignment, allow study staff to visit them at their primary care clinic for two follow-up visits
- Likely to relocate within next 6 months and no longer be seen at clinic within the next 12 months
- Weight loss ≥5% of body weight in past 6 months (other than postpartum)
- Past bariatric surgery
- Prescription weight loss medications within the past 6 months
- eGFR \< 60 within past 6 months
- Unable to ambulate
- Have end-stage medical conditions with limited life expectancy
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04343872
Start Date
December 10 2020
End Date
December 31 2022
Last Update
March 5 2024
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35205