Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1: Education only Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks |
Behavioral: Education
Healthy-lifestyle and diabetes-related virtual education (text and videos)
Other Names:
|
| Experimental: Group 2: Education and Meals 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
Healthy-lifestyle and diabetes-related virtual education (text and videos)
Other Names:
Behavioral: Meal delivery
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
Other Names:
|
| Experimental: Group 3: Education, Meals, Coaching 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
Healthy-lifestyle and diabetes-related virtual education (text and videos)
Other Names:
Behavioral: Meal delivery
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
Other Names:
Behavioral: Lifestyle coaching
calls with coach and/or nutritionist, access to Facebook community support group
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in mean glucose time in range from baseline at Week 6 [Week 0 and 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
- Change in mean glucose time in range from baseline at Week 12 [Week 0 and 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
- Change in mean glucose time in range from baseline at Week 16 [Week 0 and 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
Secondary Outcome Measures
- Change in CGM-derived glucose features from baseline [Week 0, Week 6, Week 12, and Week 16]
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
- Change in blood test results from baseline [Week 0, Week 12]
Difference in measurements of HbA1c, HDL cholesterol, total cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) obtained from blood tests
- Change in self-reported waist-to-hip ratio [Weekly, Weeks 0-12]
waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference
- Change in self-reported blood pressure [Weekly, Weeks 0-12]
blood pressure, self-reported weekly
Other Outcome Measures
- Visits to site [Week 16]
Usage stats from website that hosts educational materials, from Week 1 through Week 16
- Percentage of tasks completed [Week 16]
Usage stats from website that hosts educational materials, from Week 1 through Week 16
- Number of interactions with lifestyle coach [Week 12]
Count of total interactions from Week 1 to Week 12
- Change from baseline in modified Yale Food Addiction Scale score at Week 6, Week 13 [Week 0, Week 6, Week 13]
modified food addiction scale, compared to responses at baseline, where higher scoring indicate a worse outcome; to meet the food addiction threshold, participants must meet the threshold for either question 6 or 7, and the threshold for 3 or more of the remaining questions
- Change from baseline in abbreviated Medical Outcomes Study Sleep Scale [Week 0, Week 13]
Responses to an abbreviated Medical Outcomes Study Sleep Scale, compared to responses at baseline; with the exception of question 2, higher scores indicate a worse outcome and the range of scores (excluding question 2) is 11 - 65
Eligibility Criteria
Criteria
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OptumLabs | Minnetonka | Minnesota | United States | 55343 |
Sponsors and Collaborators
- UnitedHealth Group
Investigators
- Principal Investigator: Katlyn A Fleming, PhD, UnitedHealth Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-0068