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

NCT06387797 | Active Not Recruiting

• 1 other identifier: UNLV-2023-321
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

At Risk for Type 2 Diabetes Mellitus; Pre Diabetes

Keywords

pre-diabetes; primary prevention; adults

Outcome Measures

Primary Outcomes (3)

• Feasibility of conducting the intervention

  Study team will analyze rate and success with recruiting, retention in the study, completion, adherence to protocol

  At one year

• Acceptability of the intervention

  Participant will rate the intervention overall for acceptability

  At 6-weeks

• Acceptability of each cooking class

  Participants will rate each cooking class for acceptability

  week 1, week 2, week 3, week 4, week 5, and week 6

Secondary Outcomes (10)

• Knowledge about the importance of produce consumption

  baseline and week 6

• Attitudes toward produce consumption

  baseline and week 6

• Intentions to consume recommended amounts of produce during and after intervention

  baseline and week 6

• Changes in fruit and vegetable consumption in servings per day

  baseline and week 6

• HbA1c%

  baseline and week 6

Other Outcomes (15)

• blood pressure in mmHg

  baseline and week 6

• fasting blood glucose in mg/dL

  baseline and week 6

• fasting total cholesterol in mg/dL

  baseline and week 6

Study Arms (2)

Cooking Matters for Adults (CMA)

ACTIVE COMPARATOR

Arm 1) CMA: 6 didactic sessions delivered once per week for 6 weeks at the UNLV Nutrition Center (in person) Baseline and post-test assessments and 6 cooking classes. * Lesson 1: Let's Get Cooking! * Lesson 2: Choosing Fruits, Vegetables and Whole Grains * Lesson 3: Healthy Starts at Home * Lesson 4: The Power of Planning * Lesson 5: Shopping Smart * Lesson 6: Recipes for Success

Behavioral: Cooking Matters for Adults (CMA)

Cooking Matters for Adults (CMA+)

EXPERIMENTAL

Baseline and Post-test assessments and The CMA curriculum + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM.

Behavioral: Cooking Matters for Adults (CMA+)

Interventions

Cooking Matters for Adults (CMA) BEHAVIORAL

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.

Cooking Matters for Adults (CMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead
• University of Nevada, Reno: collaborator

Study Sites (1)

University of Nevada, Las Vegas

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sara K Rosenkranz, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because of the parallel arm differences, it would not be possible to mask the arm assignment for the participant or investigator. However, we will mask the arm assignment for the outcomes assessor, in particular for the HbA1c% assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Kinesiology and Nutrition Sciences

Model Details: Participants will be randomized to one of two parallel study arms. 1. Cooking Matters for Adults (CMA) Curriculum Delivery over 6 weeks 2. CMA + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, online information as well as short assignments and activities regarding sleep, stress, physical activity, and sedentary behaviors. The CMA+ arm will also have the opportunity to use a continuous glucose monitor (CGM) for 10 days immediately following the baseline assessment visit. This will be an optional component and participants will not be excluded if they do not wish to use the CGM. (6 weeks)

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 6 months after publication of the primary outcomes manuscript for a minimum of three years.
• Access Criteria: Upon reasonable request to the study PI

Locations

US (1)