Nutrition education intervention for preventing type 2 diabetes in at-risk adults
Primary and Secondary Prevention of Type 2 Diabetes Mellitus in At-risk and Underrepresented Minority Populations in Clark County Through Enhanced Nutrition Cooking Education
NA · University of Nevada, Las Vegas · NCT06387797
This study tests whether a special nutrition education program can help adults at risk for type 2 diabetes improve their eating habits and lower their health risks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nevada, Las Vegas (other) |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT06387797 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a nutrition education intervention aimed at preventing type 2 diabetes among at-risk adults in Clark County. Participants will be divided into two groups: one receiving a standard nutrition curriculum and the other receiving an enhanced version that includes diabetes-specific information and continuous glucose monitoring. The study will assess the feasibility and acceptability of the intervention, as well as its preliminary effectiveness in improving dietary habits and reducing cardiometabolic risk factors. Baseline assessments will include various health metrics and questionnaires to gather data on participants' health behaviors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with pre-diabetes or those self-identifying as at-risk for type 2 diabetes mellitus.
Not a fit: Patients who have already been diagnosed with type 2 diabetes or have HbA1c levels indicating diabetes will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of type 2 diabetes among at-risk populations, leading to better health outcomes and reduced healthcare costs.
How similar studies have performed: Other studies have shown success with similar nutrition education interventions for diabetes prevention, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: People with pre-diabetes, or those self-identifying as at-risk for type 2 diabetes mellitus (T2DM). Risk for T2DM can be determined through indicators such as family history of T2DM, overweight or obesity, metabolic syndrome, HbA1c levels between 5.7% and 6.4%, or fasting blood glucose levels between 100 and 125 mg/dL. There is increased risk for T2DM among American Indian/Alaska Native, Black and Hispanic adults as compared with White and Asian adults; adults ages 25 and older with less than a high school education, as compared with those with higher education levels; and adults ages 25 and older with household incomes less than $25,000 as compared with those with higher income levels. Exclusion Criteria: People who have been diagnosed with T2DM or tested at an HbA1c% level that indicates T2DM. (\>6.4%) People who are non-English speaking (this is a feasibility/pilot study, if effective we will propose a fully-powered trial that we plan to translate into Spanish). The curriculum we are using has a Spanish version that we can make available if needed once a participant is enrolled. Additionally, the study coordinator is a student listed on this application who is fluent in Spanish and can help those with limited English capability to ensure participants understand the study and what is expected. People who are unable to attend in-person cooking classes at the UNLV Nutrition Center for 6 weeks using their own means of transportation. People who are unwilling to undergo multiple finger-sticks for determining HbA1c, lipids, and glucose levels. Anyone who has been diagnosed with cardiovascular or metabolic diseases, and or using medications currently to control blood glucose, including Metformin or insulin. People who have uncontrolled high blood pressure (SBP: \>=140/DBP \>=90) People who have implantable metal; (e.g., pacemaker) because body composition will be measured via bioimpedance. People who are actively trying to lose weight, or currently enrolled in a weight loss program or other dietary intervention. People who have dietary restrictions including those following a vegan diet, gluten-free diet, or with food allergies to any fruits or vegetables.
Where this trial is running
Las Vegas, Nevada
- University of Nevada, Las Vegas — Las Vegas, Nevada, United States (RECRUITING)
Study contacts
- Principal investigator: Sara K Rosenkranz, PhD — University of Nevada, Las Vegas
- Study coordinator: Sara K Rosenkranz, PhD
- Email: Sara.Rosenkranz@unlv.edu
- Phone: 702-895-0938
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: At Risk for Type 2 Diabetes Mellitus, Pre Diabetes, pre-diabetes, primary prevention, adults