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

Primary Purpose

PreDiabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Education

Meal delivery

Lifestyle coaching

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

OptumLabs

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Group 1: Education only

Group 2: Education and Meals

Group 3: Education, Meals, Coaching

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

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

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

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

Change in self-reported blood pressure

blood pressure, self-reported weekly

Full Information

NCT ID

NCT04810026

First Posted

March 12, 2021

Last Updated

February 4, 2022

Sponsor

UnitedHealth Group

1. Study Identification

Unique Protocol Identification Number

NCT04810026

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

May 3, 2021 (Actual)

Primary Completion Date

October 26, 2021 (Actual)

Study Completion Date

October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

UnitedHealth Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Education only

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group 2: Education and Meals

Arm Type

Experimental

Arm 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

Arm Title

Group 3: Education, Meals, Coaching

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Education

Other Intervention Name(s)

diabetes self-management education, healthy-lifestyle education

Intervention Description

Healthy-lifestyle and diabetes-related virtual education (text and videos)

Intervention Type

Behavioral

Intervention Name(s)

Meal delivery

Other Intervention Name(s)

Nutrition for Longevity meals, Longevity Diet

Intervention Description

breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle coaching

Other Intervention Name(s)

Longevity Program

Intervention Description

calls with coach and/or nutritionist, access to Facebook community support group

Primary Outcome Measure Information:

Title

Change in mean glucose time in range from baseline at Week 6

Description

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

Time Frame

Week 0 and Week 6

Title

Change in mean glucose time in range from baseline at Week 12

Description

Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results

Time Frame

Week 0 and Week 12

Title

Change in mean glucose time in range from baseline at Week 16

Description

Percentage of time estimated glucose value (EGV) from CGM is between 70 mg/dL and 180 mg/dL, measured daily with weekly composite results

Time Frame

Week 0 and Week 16

Secondary Outcome Measure Information:

Title

Change in CGM-derived glucose features from baseline

Description

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

Time Frame

Week 0, Week 6, Week 12, and Week 16

Title

Change in blood test results from baseline

Description

Difference in measurements of HbA1c, HDL cholesterol, total cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein (hs-CRP) obtained from blood tests

Time Frame

Week 0, Week 12

Title

Change in self-reported waist-to-hip ratio

Description

waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference

Time Frame

Weekly, Weeks 0-12

Title

Change in self-reported blood pressure

Description

blood pressure, self-reported weekly

Time Frame

Weekly, Weeks 0-12

Other Pre-specified Outcome Measures:

Title

Visits to site

Description

Usage stats from website that hosts educational materials, from Week 1 through Week 16

Time Frame

Week 16

Title

Percentage of tasks completed

Description

Usage stats from website that hosts educational materials, from Week 1 through Week 16

Time Frame

Week 16

Title

Number of interactions with lifestyle coach

Description

Count of total interactions from Week 1 to Week 12

Time Frame

Week 12

Title

Change from baseline in modified Yale Food Addiction Scale score at Week 6, Week 13

Description

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

Time Frame

Week 0, Week 6, Week 13

Title

Change from baseline in abbreviated Medical Outcomes Study Sleep Scale

Description

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

Time Frame

Week 0, Week 13

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Katlyn A Fleming, PhD

Organizational Affiliation

UnitedHealth Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

OptumLabs

City

Minnetonka

State/Province

Minnesota

ZIP/Postal Code

55343

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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