Clinical trial NCT04810026: Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care
Official title: Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Keywords: 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
Lead sponsor: UnitedHealth Group
Sponsor class: INDUSTRY
First posted: 2021-03-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Change in mean glucose time in range from baseline at Week 6
timeFrame: Week 0 and Week 6
measure: Change in mean glucose time in range from baseline at Week 12
timeFrame: Week 0 and Week 12
measure: Change in mean glucose time in range from baseline at Week 16
timeFrame: Week 0 and Week 16
Secondary outcomes:
measure: Change in CGM-derived glucose features from baseline
timeFrame: Week 0, Week 6, Week 12, and Week 16
measure: Change in blood test results from baseline
timeFrame: Week 0, Week 12
measure: Change in self-reported waist-to-hip ratio
timeFrame: Weekly, Weeks 0-12
measure: Change in self-reported blood pressure
timeFrame: Weekly, Weeks 0-12
Other outcomes:
measure: Visits to site
timeFrame: Week 16
measure: Percentage of tasks completed
timeFrame: Week 16
measure: Number of interactions with lifestyle coach
timeFrame: Week 12
measure: Change from baseline in modified Yale Food Addiction Scale score at Week 6, Week 13
timeFrame: Week 0, Week 6, Week 13
measure: Change from baseline in abbreviated Medical Outcomes Study Sleep Scale
timeFrame: Week 0, Week 13
Locations:
city: Minnetonka
country: United States
facility: OptumLabs
state: Minnesota
Study officials:
affiliation: UnitedHealth Group
name: Katlyn A Fleming, PhD
role: PRINCIPAL_INVESTIGATOR
References: