Primary and Secondary Prevention of Type 2 Diabetes Mellitus in At-risk and Underrepresented Minority Populations in Clark County Through Enhanced Nutrition Cooking Education
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Feasibility of conducting the intervention
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cooking Matters for Adults (CMA)
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
干预措施: Cooking Matters for Adults (CMA) (Behavioral)
Cooking Matters for Adults (CMA+)
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.
干预措施: Cooking Matters for Adults (CMA+) (Behavioral)
结局指标
主要结局
Feasibility of conducting the intervention
时间窗: At one year
Study team will analyze rate and success with recruiting, retention in the study, completion, adherence to protocol
Acceptability of each cooking class
时间窗: week 1, week 2, week 3, week 4, week 5, and week 6
Participants will rate each cooking class for acceptability
Acceptability of the intervention
时间窗: At 6-weeks
Participant will rate the intervention overall for acceptability
次要结局
- Attitudes toward produce consumption(baseline and week 6)
- Changes in fruit and vegetable consumption in servings per day(baseline and week 6)
- body fat percentage (%)(baseline and week 6)
- non fat mass in kg(baseline and week 6)
- Intentions to consume recommended amounts of produce during and after intervention(baseline and week 6)
- Body weight in kg(baseline and week 6)
- waist circumference in cm(baseline and week 6)
- Knowledge about the importance of produce consumption(baseline and week 6)
- Gut Microbiota composition(week 1, week 2, week 3, week 4, week 5, and week 6)
- HbA1c%(baseline and week 6)
研究者
Sara K Rosenkranz
Associate Professor in Kinesiology and Nutrition Sciences
University of Nevada, Las Vegas