Prediabetic StateNCT06897982
Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center
A study testing One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles in people with Prediabetic State and PreDiabetes, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Prediabetic State, PreDiabetes, Health Knowledge, Attitudes, Practice
- What is being tested?
- One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Leslie Aguillar-Hernandez, 4243151042, leslie.aguilar-hernandez@cshs.org
About this study
Official title: 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
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
Read the 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
- Being tested
- One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles
- Medical subject headings
- Prediabetic State, Behavior, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los AngelesBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| DPP Clinic Participants | Experimental | 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 Receives: Behavioral: One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
The primary outcome of this feasibility study will be retention in the DPP. Retention will be defined as participation in 9 of the 16 core DPP sessions during months 1 through 6 of the DPP. This measure will assess participant completion of the DPP. % retention will be measured at the end of the DPP.
Measured: Post-Intervention (12-months as DPP is a year-long program)
Secondary outcomes (2)
Recruitment Rate of Participants for Nutrition Intervention
Secondary outcomes of this feasibility study will be to assess the number of DPP patients recruited for this nutrition intervention study. This will be assessed initially at Baseline by total number enrolled and during the intervention (Weeks 1-7) by collecting participant attendance at each weekly nutrition intervention session to see if there is any change in attendance.
Measured: Baseline and During Intervention (Weeks 1-7)
Change in Participant Acceptability of the Nutrition Intervention
Secondary outcomes of this feasibility study will be to assess participant acceptability of the nutrition intervention, as defined by satisfaction with the nutrition intervention's cooking demonstration activities. This will be measured via a weekly Likert scale, intervention satisfaction survey. At the end of the intervention (Week 7) participants will participate in a focus group to assess satisfaction and overall acceptability of the nutrition intervention
Measured: During & Post-Intervention (Weeks 1-7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start8 Dec 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelba Castellon-Lopez, Cedars-Sinai Medical Center
- Investigators
- Yelba Castellon-Lopez, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897982
- Sponsor's protocol ID
- STUDY00004061
- Other IDs
- 7K23DK129828-03
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06897982
- Acronym / sponsor ID
- STUDY00004061
- Conditions
- Prediabetic State, PreDiabetes, Health Knowledge, Attitudes, Practice, Nutrition, Healthy, Acceptability of Health Care, Obesity Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DPP Clinic Participants | Experimental | Behavioral: One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los AngelesA 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los AngelesThis 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 | Behavioural | DPP Clinic Participants |
Primary outcome
Retention
Time frame: Post-Intervention (12-months as DPP is a year-long program)
The primary outcome of this feasibility study will be retention in the DPP. Retention will be defined as participation in 9 of the 16 core DPP sessions during months 1 through 6 of the DPP. This measure will assess participant completion of the DPP. % retention will be measured at the end of the DPP.
2 secondary outcomes
Recruitment Rate of Participants for Nutrition Intervention
Time frame: Baseline and During Intervention (Weeks 1-7)
Change in Participant Acceptability of the Nutrition Intervention
Time frame: During & Post-Intervention (Weeks 1-7)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yelba Castellon-Lopez, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles in people with Prediabetic State and PreDiabetes, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leslie Aguilar-Hernandez, BA (4243151042, leslie.aguilar-hernandez@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: Post-Intervention (12-months as DPP is a year-long program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.