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

Not Applicable

Completed

• Conditions: PreDiabetes; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Education; Behavioral: Meal delivery; Behavioral: Lifestyle coaching

• Registration Number: NCT04810026
• Lead Sponsor: UnitedHealth Group

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.

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 Timeline

• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-22
• Study Start: 2021-05-03
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Education and Meals	Meal delivery	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
Group 3: Education, Meals, Coaching	Meal delivery	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
Group 2: Education and Meals	Education	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
Group 3: Education, Meals, Coaching	Lifestyle 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
Group 1: Education only	Education	Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks
Group 3: Education, Meals, Coaching	Education	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

Primary Outcome Measures

Name	Time	Method
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 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 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

Name	Time	Method
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 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 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 self-reported blood pressure	Weekly, Weeks 0-12	blood pressure, self-reported weekly

Trial Locations

Locations (1)

OptumLabs; 🇺🇸 Minnetonka, Minnesota, United States