Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06897982

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionPrediabetic State, PreDiabetes, Health Knowledge, Attitudes, Practice, Nutrition, Healthy, Acceptability of Health Care, Obesity Prevention

Full registry 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.

Treatments and study arms

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

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

Primary outcomes

RetentionPost-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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cedars-Sinai Medical Center🇺🇸 Los Angeles, California, United States
Leslie Aguillar-HernandezContact