Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care

Study Overview
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Brief Summary
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The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio, cholesterol) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior.

Detailed Description
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The purpose of this research is to understand the impact of medically tailored meals on health-related biometrics (e.g., glucose time-in-range, waist-hip ratio) and how providing medically tailored meals promotes engagement in diabetes education and drives information-seeking behavior. Secondary purposes are to characterize the relationship between information-seeking behaviors and glycemic control; to characterize the relationship between psychometric survey results and program engagement, biometrics, and information-seeking behaviors; and to understand how meal provision and materials influence program satisfaction and adherence to healthy diabetes-related behaviors.

Official Title
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Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care

Conditions
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PreDiabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Education
* Behavioral: Meal delivery
* Behavioral: Lifestyle coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be a patient, employee, or employee dependent at Utica Park Clinic in Oklahoma Be diagnosed with type 2 diabetes, prediabetes, and/or have an A1c result of 5.7 percent or above Be above an ideal weight (for example, body mass index [BMI] greater than or equal to 25) 18 years of age or older Have UnitedHealthcare insurance for 1 year+ Have an active e-mail address Have a smartphone with access to the internet that is compatible with the Dexcom G6 app Exclusion Criteria: Be undergoing any form of cancer treatment Be pregnant or breastfeeding Have allergies to nightshade vegetable (e.g., bell peppers, potatoes, tomatoes) or legumes (e.g., green beans, peas), or tree nuts Currently taking anti-psychotic medications to control schizophrenia and bipolar disorders, as well as other mental disorders including dementia, major depression, and even drug addiction Be currently taking insulin Be currently taking sulfonylureas

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Education only<br>Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks | Behavioral: Education<br>* Healthy-lifestyle and diabetes-related virtual education (text and videos)<br>* Other names: healthy-lifestyle education;|
| Experimental: Group 2: Education and Meals<br>Meal delivery (3 meals per day, 5 days per week) for 12 weeks, push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks | Behavioral: Education<br>* Healthy-lifestyle and diabetes-related virtual education (text and videos)<br>* Other names: healthy-lifestyle education;Behavioral: Meal delivery<br>* breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles<br>* Other names: Longevity Diet;|
| Experimental: Group 3: Education, Meals, Coaching<br>Meal delivery (3 meals per day, 5 days per week) for 12 weeks, coaching program (e.g., diabetes-specific coaching and education, push notifications for lifestyle education modules, community support) for 12 weeks, and passive access to lifestyle education for final 4 weeks | Behavioral: Education<br>* Healthy-lifestyle and diabetes-related virtual education (text and videos)<br>* Other names: healthy-lifestyle education;Behavioral: Meal delivery<br>* breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles<br>* Other names: Longevity Diet;Behavioral: Lifestyle coaching<br>* calls with coach and/or nutritionist, access to Facebook community support group<br>* Other names: Longevity Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean glucose time in range from baseline at Week 6 | Percentage of time estimated glucose value (EGV) from continuous glucose monitor (CGM) is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results | Week 0 and Week 6 | 
| Change in mean glucose time in range from baseline at Week 12 | Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results | Week 0 and Week 12 | 
| Change in mean glucose time in range from baseline at Week 16 | Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results | Week 0 and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CGM-derived glucose features from baseline | Average of EGVs, percentage time above and below range (< 70 mg/dL or >180 mg/dL), and glucose variability (standard deviation of EGVs), measured via daily with weekly composite results | Week 0, Week 6, Week 12, and Week 16 | 
| Change in blood test results from baseline | Difference in measurements of HbA1c, HDL cholesterol, total cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) obtained from blood tests | Week 0, Week 12 | 
| Change in self-reported waist-to-hip ratio | waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference | Weekly, Weeks 0-12 | 
| Change in self-reported blood pressure | blood pressure, self-reported weekly | Weekly, Weeks 0-12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, type 2, information seeking behavior, waist-hip ratio, blood pressure, weight, prediabetes, glycemic control, diet, life style, cholesterol, meal delivery, nutrition, continuous glucose monitoring, CGM, self report, education, coaching, yoga, meditation, human