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

Pre Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06387797
• Other study ID #: UNLV-2023-321
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: University of Nevada, Las Vegas
• Contact: Sara K Rosenkranz, PhD
• Phone: 702-895-0938
• Email: Sara.Rosenkranz[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The long-term goal of this study is to reduce the healthcare costs and burdens associated with T2DM among at-risk populations in Nevada by reducing the incidence of type 2 diabetes mellitus. For the current study, the investigators will determine the feasibility and acceptability of this 6-week intervention. Short-term objectives for the current pilot and feasibility study include developing recruitment, screening, and delivery processes through UNLV's Nutrition Center to improve future extramural grant applications. The investigators hope to have preliminary data regarding whether or not a 6-week enhanced diabetes prevention nutrition education intervention (with education about multiple lifestyle behaviors) is more effective than the basic CMA curriculum for improving cardiometabolic health outcomes that represent risk for developing type 2 diabetes. Additionally, the investigators are using feedback tools to help participants in the enhanced study arm to see their continuous glucose levels in real-time, and to understand the composition of their gut microbiome via collection of stool swab samples.

Baseline Assessments will include:

Finger-sticks for lipids, glucose, and HbA1c%, BIA body composition assessments including height and weight, waist circumference, blood pressure, and questionnaire completion.

Questionnaires will include:

Health History Questionnaire Physical activity and sedentary behavior (IPAQ-short form) (10-15minutes) Dietary intake (3-day dietary recall via ASA24) (Online-15 minutes for each recall) Stress (PSS-10) (10minutes) Sleep quantity and quality (Pittsburgh Sleep Quality Index and Sleep Hygiene Index) (10-15 minutes) Nutrition security screener (5minutes) In addition to these questionnaires, participants will be asked to complete standard questions that are used in the CMA curriculum.

An accelerometer will be secured via an adhesive pocket attached to the front upper thigh, for at least 7 days from the time participants get up to the time they go to bed.

Following baseline assessments, participants will be randomized to the CMA only or the CMA+ arm of the study. Participants randomized to the CMA+ arm will also have a CGM attached to their upper arm (non-dominant hand). Once at least 20 participants have been enrolled, the cooking classes will be scheduled in cohorts of 12-15 participants per study arm, based on limited capacity in the Nutrition Center kitchen. Multiple cohorts will be enrolled during the 2-year period of the grant up to enrollment of 120 participants.

The CMA Curriculum will be used for both arms of the intervention. Participants will attend cooking and educational sessions once per week for 6 weeks. In addition, participants will receive recipes and produce boxes with instructions to prepare the recipe at some point prior to their next class. Participants will also be invited to the online Google Classroom site where all intervention materials (according to the study arm they are randomized to) will be housed for their convenience. Each week, participants will collect their fecal samples in the privacy of their own homes and will return them at their next cooking class. Investigators will provide paper bags that are opaque for privacy for participants to use for returning their samples. Participants 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 in the CMA+ arm). Using a basic collection scoop in a DNA/RNA shield is recommended for this purpose.

The CMA+ arm will also use the CMA Curriculum, but will also include 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. 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.

For both arms, the Google Classrooms platform will be used to house curriculum materials, allow for social interaction and questions to the researchers, and will include videos of cooking demonstrations, ideas for the enhanced arm about how to implement strategies for behavior change for lifestyle behaviors (sleep, physical activity, dietary intake, sedentary behavior, and stress).

Follow-up (at 6 weeks):

Following the completion of the 6-week intervention period, follow-up assessments will be conducted again via appointment at BHS 343 (these will be identical to the baseline assessment visit without the CGM or informed consent processes. Additionally, only 1 24-hour food recall will be conducted at this follow-up visit. These procedures will include Finger-sticks for lipids, glucose, and HbA1c%, BIA body composition assessments including height and weight, waist circumference, blood pressure, and questionnaire completion. 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. This will allow investigators to determine preliminary adherence to any changes from baseline.

If a participant discontinues their participation in the study, any data collected up to that point will be retained for analysis, following the intent-to-treat principle. Since blood will only be collected through finger-stick samples, these will be immediately analyzed upon collection, and the blood will be safely disposed of in a biohazard container. Sharps will be discarded in designated sharps containers. There will be no storage of plasma or blood samples.

All data will be promptly entered into the study database and will be identified solely by a unique study ID number (a randomly generated 3-digit code combined with the study abbreviation and visit number). To ensure confidentiality, all data will be deidentified for storage (electronic and paper-based) public presentations and subsequent publications. Any personally identifiable information will be stored exclusively in hard copy, within a locked file cabinet, accessible only to the Principal Investigator and authorized study personnel. The CMA comprises 6 nutrition education workshops. Over the 2-year study period. We will deliver a series of 5 sessions (2 months duration) including 2 cohorts in each session, for a total of 10 cohorts of 12-15 participants. The sessions will be led by a Nutrition Sciences graduate student who is seeking the Registered Dietitian Nutritionist (RDN) credential or who already holds the RDN credential.

Arm 1) CMA: 6 didactic sessions delivered once per week for 6 weeks

• 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

Arm 2) CMA+: 6 didactic sessions + Enhanced cooking classes with added components comprising cooking practices specific to diabetes prevention, strategies for increasing self-efficacy for fruit and vegetable consumption, and weekly produce distribution.

o After completion of the program, participants who are eligible will be referred to a DSMPE, diabetes nutrition education and cooking classes (6 weeks) through the Southern Nevada Health District.

• Six weeks after intervention completion, we will follow-up with program participants through phone and/or email to determine sustainability of any behavioral changes, and to better understand barriers to fruit and vegetable consumption.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 31, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Pre Diabetes
• Prediabetic State

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Nevada, Las Vegas	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas	University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood pressure in mmHg	blood pressure assessment via automated blood pressure device	baseline and week 6
Other	fasting blood glucose in mg/dL	fasting blood glucose via capillary whole blood from a fingerstick	baseline and week 6
Other	fasting total cholesterol in mg/dL	fasting total cholesterol via capillary whole blood from a fingerstick	baseline and week 6
Other	fasting LDL cholesterol in mg/dL	fasting LDL cholesterol via capillary whole blood from a fingerstick	baseline and week 6
Other	fasting HDL cholesterol in mg/dL	fasting HDL cholesterol via capillary whole blood from a fingerstick	baseline and week 6
Other	fasting triglyceride level in mg/dL	fasting triglyceride level via capillary whole blood from a fingerstick	baseline and week 6
Other	Usual dietary quality	3-day food recall at baseline via researcher led online ASA24 to determine usual dietary quality, scored via the Healthy Eating Index	baseline and post-test
Other	Week 6 dietary quality	1-day food recall via researcher led online ASA24 to determine dietary quality scored via the Healthy Eating Index	week 6
Other	physical activity energy expenditure average kcals per day	Fibion accelerometer attached to upper thigh to measure physical activity energy expenditure	baseline and week 6
Other	Time spent in sedentary behavior in minutes per day	Fibion accelerometer attached to upper thigh to measure time spent in sedentary behavior and International Physical Activity Questionnaire-Short form (IPAQ-SF)	baseline and week 6
Other	physical activity intensity distribution as minutes per day and average percentage of day	Fibion accelerometer attached to upper thigh and International Physical Activity Questionnaire-Short form (IPAQ-SF) to measure percentage time spent in different physical activity intensities (light, moderate, and vigorous physical activity)	baseline and week 6
Other	sleep quantity in hours per day	hours of sleep reported via Fibion accelerometer attached at the front of the thigh and self-report using the Pittsburgh Sleep Quality Index Questionnaire	baseline and week 6
Other	sleep quality	hours of sleep and quality of sleep reported via accelerometer and self-report using the Pittsburgh Sleep Quality Index Questionnaire and the Sleep Hygiene Index Questionnaire	baseline and week 6
Other	stress levels	Perceived Stress Scale 10 (PSS-10) questionnaire used to assess stress levels	baseline and week 6
Other	Nutrition Security	Nutrition security measured via self-report Nutrition Security-Screener questionnaire	baseline and week 6
Primary	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
Primary	Acceptability of the intervention	Participant will rate the intervention overall for acceptability	At 6-weeks
Primary	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	Knowledge about the importance of produce consumption	questionnaire that asks about understanding of the produce consumption for preventing diabetes	baseline and week 6
Secondary	Attitudes toward produce consumption	questionnaire asking about positive or negative perceptions of produce consumption for prevention of diabetes	baseline and week 6
Secondary	Intentions to consume recommended amounts of produce during and after intervention	questionnaire that asks for ratings of intention to consume recommended amounts of produce	baseline and week 6
Secondary	Changes in fruit and vegetable consumption in servings per day	questionnaire of servings of fruits and vegetables consumed per week	baseline and week 6
Secondary	HbA1c%	hemoglobin A1c% from fingerstick	baseline and week 6
Secondary	Body weight in kg	body weight measured using SECA bio-electrical impedance scale	baseline and week 6
Secondary	Gut Microbiota composition	ratio of beneficial/harmful bacteria and microbiota alpha and beta-diversity from participant stool samples	week 1, week 2, week 3, week 4, week 5, and week 6
Secondary	waist circumference in cm	waist circumference measured via tape measure	baseline and week 6
Secondary	body fat percentage (%)	body fat percentage determined via SECA bio-electrical impedance scale	baseline and week 6
Secondary	non fat mass in kg	amount of mass that is not body fat determined by SECA bio-electrical impedance scale	baseline and week 6