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
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
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
Single group
One-arm feasibility pilot of a nutrition intervention to recruit, engage, and retain DPP participants in the safety-net setting in Los Angeles
BehavioralThis 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
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.
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.
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
Healthy Food Environment Assessment
Using the 3-Item Healthy Food Environments Protocol, a self-reported food environment assessment, the study will measure the quality and availability of fresh fruit and vegetables and low-fat products in the local neighborhood. Higher mean scores indicate greater availability of healthy foods in the neighborhood (i.e., low-fat products, fruits, and vegetables).
Change in Food Insecurity
Other outcomes of this feasibility study will collect data on participant experience with food insecurity. This will be evaluated using a 6-Item food Insecurity measure from U.S. Department of Agriculture Economic Research Service.
Change in Self-Efficacy
Other outcomes of this feasibility study will collect a self-report measure of self-efficacy using a 4-item Brief Self-Efficacy Scale for Healthful Eating
Change in Biometric Data
Other outcomes of this feasibility study will collect data on participant weight (this is already collected at DPP classes) HR, sleep hours. The purpose of collecting this data is to assess potential outcomes that should be collected in a future pragmatic and fully powered RCT comparing DPP + nutritional intervention and DPP alone.
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Cedars-Sinai Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
