Recruiting

Diabetes Prevention Program

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT06897982

Conditions

Prediabetic State

PreDiabetes

Health Knowledge, Attitudes, Practice

Nutrition, Healthy

Acceptability of Health Care

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Conditions

Prediabetic State

PreDiabetes

Health Knowledge, Attitudes, Practice

Nutrition, Healthy

Acceptability of Health Care

Study ID

NCT06897982

Start date

Dec 8, 2025

Status verified date

Jan, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: DPP Clinic Participants

A single arm approach with two groups of ten collected a two different time points in the year of the clinic's DPP. These will not be compared to each other they will be used to collect feasibility outcomes data to inform a future pilot randomized study

Interventions

One-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

Primary outcome measure

  • Retention [ Time Frame: Post-Intervention (12-months as DPP is a year-long program) ]

Central Contacts and Locations

Central contacts

Leslie Aguilar-Hernandez, BA

4243151042leslie.aguilar-hernandez@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Leslie Aguillar-Hernandez

4243151042leslie.aguilar-hernandez@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-01-20.