Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center
Recruiting · NCT06897982 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedars-Sinai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles
What this trial is about
The purpose of the study is to assess the feasibility and acceptability of incorporating hands-on nutritional demonstrations to enhance the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 18+ years old
- BMI of 25 or higher (23 or higher if Asian)
- Meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4%
- Not be diagnosed with type 1 or type 2 diabetes
- Moderate to high risk of having prediabetes or a known diagnosis of prediabetes by their medical provider in the last 12 months.
- Eligible or enrolled in the Diabetes Prevention Program
Exclusion criteria
- Younger than 18 years of age
- BMI of less than 25 or higher (or under 23 if Asian)
- Does not meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg/dL or an A1C level between 5.7-6.4%
- Currently diagnosed with type 1 or type 2 diabetes
- Has not been diagnosed as moderate to high risk of having prediabetes or having a known diagnosis of prediabetes by their medical provider in the last 12 months.
Where it is running
1 location listed across 1 US state.
- Cedars-Sinai Medical Center - Los Angeles, California, United States