Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care
Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2021
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
May 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedFebruary 23, 2022
February 1, 2022
6 months
March 12, 2021
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Change in CGM-derived glucose features from baseline
Week 0, Week 6, Week 12, and Week 16
Change in blood test results from baseline
Week 0, Week 12
Change in self-reported waist-to-hip ratio
Weekly, Weeks 0-12
Change in self-reported blood pressure
Weekly, Weeks 0-12
Other Outcomes (5)
Visits to site
Week 16
Percentage of tasks completed
Week 16
Number of interactions with lifestyle coach
Week 12
- +2 more other outcomes
Study Arms (3)
Group 1: Education only
ACTIVE COMPARATORPush notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks
Group 2: Education and Meals
EXPERIMENTALMeal 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
EXPERIMENTALMeal 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
Interventions
Healthy-lifestyle and diabetes-related virtual education (text and videos)
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
calls with coach and/or nutritionist, access to Facebook community support group
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OptumLabs
Minnetonka, Minnesota, 55343, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katlyn A Fleming, PhD
UnitedHealth Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Fellow
Study Record Dates
First Submitted
March 12, 2021
First Posted
March 22, 2021
Study Start
May 3, 2021
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
February 23, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Immediately following publication, no end date
- Access Criteria
- Investigators who provide a methodologically sound proposal for analyses within the bounds of consent, and approved by an independent review committee for analyses not within the bounds of consent. Data will be stored in UnitedHealth Group database and will not be publicly available.
All of the individual participant data (IPD) that has been collected during the trial and de-identified