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

UnitedHealth Group

Status: Completed

Conditions: Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Behavioral: Lifestyle coaching; Behavioral: Education; Behavioral: Meal delivery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04810026

2020-0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Group 1: Education only

Active Comparator group

Description:

Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks

Treatment:

Behavioral: Education

Group 2: Education and Meals

Experimental group

Description:

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

Treatment:

Behavioral: Meal delivery

Behavioral: Education

Group 3: Education, Meals, Coaching

Experimental group

Description:

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

Treatment:

Behavioral: Meal delivery

Behavioral: Education

Behavioral: Lifestyle coaching