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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; PreDiabetes
• Intervention / Treatment: Behavioral: Education; Behavioral: Meal delivery; Behavioral: Lifestyle coaching

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minnetonka, Minnesota, United States, 55343
      • OptumLabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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: diabetes self-management education; healthy-lifestyle education
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: diabetes self-management education; healthy-lifestyle education; Behavioral: Meal delivery; breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles; Other Names: Nutrition for Longevity meals; Longevity Diet
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: diabetes self-management education; healthy-lifestyle education; Behavioral: Meal delivery; breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles; Other Names: Nutrition for Longevity meals; Longevity Diet; Behavioral: Lifestyle coaching; calls with coach and/or nutritionist, access to Facebook community support group; Other Names: Longevity Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CGM-derived glucose features from baseline	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	Week 0, Week 6, Week 12, and Week 16
Change in blood test results from baseline	Difference in measurements of HbA1c, HDL cholesterol, total cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) obtained from blood tests	Week 0, Week 12
Change in self-reported waist-to-hip ratio	waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference	Weekly, Weeks 0-12
Change in self-reported blood pressure	blood pressure, self-reported weekly	Weekly, Weeks 0-12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visits to site	Usage stats from website that hosts educational materials, from Week 1 through Week 16	Week 16
Percentage of tasks completed	Usage stats from website that hosts educational materials, from Week 1 through Week 16	Week 16
Number of interactions with lifestyle coach	Count of total interactions from Week 1 to Week 12	Week 12
Change from baseline in modified Yale Food Addiction Scale score at 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	Week 0, Week 6, Week 13
Change from baseline in abbreviated Medical Outcomes Study Sleep Scale	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	Week 0, Week 13

Collaborators and Investigators

• Sponsor: UnitedHealth Group
• Investigators: Principal Investigator: Katlyn A Fleming, PhD, UnitedHealth Group

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: nutrition; meditation; blood pressure; yoga; diabetes mellitus, type 2; CGM; human; education; diet; prediabetes; continuous glucose monitoring; cholesterol; glycemic control; weight; coaching; life style; information seeking behavior; waist-hip ratio; meal delivery; self report
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2020-0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All of the individual participant data (IPD) that has been collected during the trial and de-identified
• IPD Sharing Time Frame: Immediately following publication, no end date
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No