RecruitingNot ApplicableNCT06897982

Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center

One-arm Feasibility and Acceptability Pilot Study of a Community-informed Nutrition Intervention to Recruit, Engage, and Retain Patients Who Are Eligible to Participate in the Diabetes Prevention Program at Two Community Health Centers in Los Angeles

Sponsor

Cedars-Sinai Medical Center

Enrollment

20 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Prediabetic State

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

+ 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 Criteria5

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALOne-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles

This clinical trial incorporates a behavioral intervention as the primary outcome of Aim 3 is to assess the feasibility and acceptability of adding an educational intervention using nutritional demonstrations aligned with the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes. The purpose of this study is to assess if having a nutritional demonstration as part of the DPP would be accepted by clinic DPP patients and hear their perspectives about if this would help them in achieving DPP goals of achieving at least 5% weight loss and implementing sustainable lifestyle changes with healthy eating to reduce their risk of prediabetes. The intervention is designed to encourage healthier eating habits and encourage clinic DPP patients to incorporate this into their daily lives. This study will also determine if it is feasible to incorporate nutritional demonstrations to enhance the existing DPP curriculum