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RECRUITING

NCT06387797

Primary and Secondary Prevention of Type 2 Diabetes Mellitus in Clark County

Sponsor: University of Nevada, Las Vegas

View on ClinicalTrials.gov

Summary

This pilot and feasibility study aims to assess the effectiveness of a nutrition education intervention using the Cooking Matters for Adults Curriculum (SNAP-Ed). The study compares this standard curriculum with an enhanced version that includes the same curriculum but has additional components, incorporating specific information related to type 2 diabetes. Additionally, participants in the enhanced group will receive continuous glucose monitors to wear during the study for 10 days. The primary outcomes of the study include evaluating the acceptability of the intervention, and the feasibility of conducting the intervention at the UNLV Nutrition Center. The investigators will also assess participants' Knowledge, Attitudes, and Intentions regarding produce consumption. Alongside feasibility and acceptability, the study aims to explore the preliminary effectiveness of the intervention in increasing fruit and vegetable consumption, reducing HbA1c, managing cardiometabolic risk, and improving gut microbiome composition and diversity among participants in the program. The investigators will also assess changes in other lifestyle behaviors from baseline to post-intervention (6 weeks) (sleep, stress, physical activity, and sedentary behavior).

Official title: Primary and Secondary Prevention of Type 2 Diabetes Mellitus in At-risk and Underrepresented Minority Populations in Clark County Through Enhanced Nutrition Cooking Education

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-10-01

Completion Date

2025-06-30

Last Updated

2024-12-06

Healthy Volunteers

Yes

Conditions

At Risk for Type 2 Diabetes Mellitus Pre Diabetes

Interventions

BEHAVIORAL

Cooking Matters for Adults (CMA+)

Six cooking classes + enhanced elements, such as diabetes-specific nutrition and cooking information, and online educational information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. This arm will have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up. Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.

BEHAVIORAL

Cooking Matters for Adults (CMA)

Participants will attend cooking and educational sessions once per week for 6 weeks. In addition, they will receive recipes and produce boxes with instructions to prepare the recipe at some point prior to their next class. They will also be invited to the online Google Classroom site where all intervention materials will be housed for their convenience. Each week, participants will collect their own fecal samples in the privacy of their own homes and will return them at their next cooking class. They will also complete a final fecal sample before the follow-up (kits provided at the final cooking class, for a total of 6 fecal samples per participant). Finally, 6-weeks after completion of the cooking classes, researchers will follow up via phone, email, or Zoom (participants will provide their preferred method of contact) to complete follow-up assessments of current lifestyle practices and barriers to fruit and vegetable consumption.

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.

Locations (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, United States