Clinical trial NCT06897982: Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prediabetic State
PreDiabetes
Health Knowledge, Attitudes, Practice
Nutrition, Healthy
Acceptability of Health Care
Obesity Prevention
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 6-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 6-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 6-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 6-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

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.

Primary outcomes:
measure: Retention
timeFrame: Post-Intervention (12-months as DPP is a year-long program)
Secondary outcomes:
measure: Recruitment Rate of Participants for Nutrition Intervention
timeFrame: Baseline and During Intervention (Weeks 1-6)
measure: Change in Participant Acceptability of the Nutrition Intervention
timeFrame: During & Post Intervention (Weeks 1-6)
Other outcomes:
measure: Healthy Food Environment Assessment
timeFrame: Pre-Intervention at Baseline
measure: Change in Food Insecurity
timeFrame: Pre- and Post-intervention (Baseline in Week 1, 12 months)
measure: Change in Self-Efficacy
timeFrame: Pre, During and Post-Intervention (Baseline in Week 1, Weekly during 6-wk intervention, Final session in 6th week)
measure: Change in Biometric Data
timeFrame: Pre, During and Post-intervention (Baseline in Week 1, Weekly during 6-wk intervention, Final session in 6th week and at 12 months for DPP end)
measure: Change in Dietary Restraint w/ Eating
timeFrame: During Intervention (Weeks 1, 3 & 6) and 12mo
measure: Change in Dietary Habits
timeFrame: Pre-Intervention and Post-Intervention (Week 1 at Baseline and Week 6)
measure: Change in Quality of Life Indicators
timeFrame: Pre, During and Post-Intervention (Baseline in Week 1, Weekly during 6-wk intervention, Final session in 6th week) and at 12mo
Locations:
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Yelba Castellon-Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References: