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

NCT ID: NCT06897982

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2027-02-28

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

Detailed Description

The purpose of Aim 3 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. We will conduct a single arm feasibility study to collect information that will help inform a future pragmatic and fully powered RCT comparing DPP + nutritional intervention and DPP alone. Participants will be recruited from federally qualified health center community clinics with an active DPP course in session. We hypothesize that participants who undergo a 7-week nutritional intervention will not only aid DPP participation and retention but provide participants with the opportunity to apply the nutrition concepts they are actively learning in the DPP in a real-world scenario so that they can incorporate it into their daily lives. Thus, aiding in the DPP's goals of achieving at least 5% weight loss and implementing sustainable lifestyle changes with healthy eating.

A total of 20 participants will be recruited from our partner federally qualified health center, safety-net community clinic sites with an existing DPP: Northeast Valley Health Corporation and AltaMed. We will recruit 2 cohorts of 10 participants each. Participants will be asked to participate in a total 7-week educational intervention using nutritional demonstrations aligned with the DPP curriculum among patients who are at-risk for prediabetes. Healthy cooking demonstrations will be led by a trained community health worker (CHW) with experience teaching about nutrition. The sessions will be co-designed by a registered dietician. Classes will be held at a community resource center with space for conducting cooking demonstrations. Classes will be held in conjunction with the existing DPP curriculum and will be offered as an opportunity to apply what is learned in the DPP curriculum. The cooking demonstrations will be in-person with a virtual option available for participants to join in if they are unable to make it to the class. This aligns with current DPP practices as participants have the option to join DPP classes in combination modality (in-person and via Zoom). The cooking demonstrations will be interactive and designed to provide individuals with prediabetes or who are at high risk of prediabetes, the skills they need to independently prepare healthy, balanced meals that support blood sugar management. The trained CHW and study team will be available to address participant questions or concerns during the 7-week cooking demonstration period. The study team will also conduct weekly check-ins with the participants during this period to collect surveys to measure satisfaction, nutritional knowledge, consumption of fruits and vegetables, and healthy eating habits. Dr. Castellon-Lopez and the study team will use standard surveys and open-ended questions to ensure that we capture the full range of perspectives from all the participants weekly and at the end of the 7-week intervention period, we will conduct audio-recorded interviews with the study participants. As this study does not involve randomization or comparison of different groups receiving different interventions, special methods for randomization are not required. Instead, the study will focus on qualitative and descriptive measures of feasibility and acceptability, such as participant feedback and engagement with nutritional intervention. The sample size was chosen based on the goal of gathering initial data on the intervention's feasibility rather than statistical comparisons or outcome changes. Data analysis will focus on understanding the intervention's feasibility within the existing DPP class structure and the acceptability of the intervention to the participants. As this is a feasibility study, our goal is to collect outcomes to plan for a future fully powered RCT and we do not anticipate having enough power to detect change in outcomes in the current study

Conditions

Prediabetic State; PreDiabetes; Health Knowledge, Attitudes, Practice; Nutrition, Healthy; Acceptability of Health Care; Obesity Prevention

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yelba Castellon-Lopez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yelba Castellon-Lopez, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leslie Aguilar-Hernandez, BA

Role: CONTACT

leslie.aguilar-hernandez@cshs.org

4243151042

Facility Contacts

Leslie Aguillar-Hernandez

Role: primary

leslie.aguilar-hernandez@cshs.org

4243151042

Other Identifiers

7K23DK129828-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004061

Identifier Type: -

Identifier Source: org_study_id