Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06897982

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

Led by Cedars-Sinai Medical Center · Updated on 2026-01-20

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Cedars-Sinai Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility and acceptability of adding hands-on nutritional demonstrations to enhance the Diabetes Prevention Program (DPP) curriculum for patients at risk of prediabetes. This study aims to support participants in achieving sustainable lifestyle changes, including at least 5% weight loss, by helping them apply nutrition concepts in real-life settings. It is a single-arm feasibility pilot conducted at federally qualified health center community clinics with active DPP courses. The study recruits 20 participants in two groups of 10, who will take part in a 7-week educational intervention featuring healthy cooking demonstrations led by a trained community health worker and designed with input from a registered dietician. These classes are offered in-person with a virtual option and coincide with the DPP sessions. The sessions focus on building skills to prepare balanced meals that support blood sugar management and encourage healthy eating habits. Participants will be monitored through weekly check-ins involving surveys about satisfaction, nutritional knowledge, fruit and vegetable intake, and healthy eating habits. The study team will conduct interviews at the end of the intervention to gather detailed feedback. The main outcome measured is participant retention at 12 months, with secondary outcomes including recruitment rates and changes in acceptability of the nutritional intervention. The data collected will inform a future randomized controlled trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years old
  • Body mass index (BMI) of 25 or higher, or 23 or higher if Asian
  • Meet blood sugar test criteria indicating prediabetes (fasting plasma glucose 110-125 mg/dL or A1C 5.7-6.4%)
  • Not diagnosed with type 1 or type 2 diabetes
  • Moderate to high risk of prediabetes or diagnosed with prediabetes in the last 12 months
  • Eligible or enrolled in the Diabetes Prevention Program
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Body mass index (BMI) below 25 (or below 23 if Asian)
  • Does not meet blood sugar test criteria indicating prediabetes
  • Diagnosed with type 1 or type 2 diabetes
  • Not diagnosed as moderate to high risk of prediabetes or without a prediabetes diagnosis in the last 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) to confirm eligibility

Outpatient Treatment

Duration - 7 weeks

Participants engage in a 7-week nutritional intervention with hands-on cooking demonstrations designed to enhance the Diabetes Prevention Program curriculum and support healthy eating habits for blood sugar management.

Weekly in-person or virtual cooking demonstration sessions plus weekly check-ins

Follow-up

Duration - Up to 12 months post-intervention

Participants complete audio-recorded interviews and ongoing assessments to evaluate feasibility and acceptability of the nutritional intervention and track retention in the Diabetes Prevention Program up to 12 months.

Periodic interviews and surveys during follow-up as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

L

Leslie Aguilar-Hernandez, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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