Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to confirm eligibility
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
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
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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