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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810026
• Other study ID #: 2020-0068
• Status: Completed
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: October 26, 2021

Study information

• Verified date: February 2022
• Source: UnitedHealth Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• Education
Healthy-lifestyle and diabetes-related virtual education (text and videos)
• Meal delivery
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
• Lifestyle coaching
calls with coach and/or nutritionist, access to Facebook community support group

Locations

Country	Name	City	State
United States	OptumLabs	Minnetonka	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visits to site	Usage stats from website that hosts educational materials, from Week 1 through Week 16	Week 16
Other	Percentage of tasks completed	Usage stats from website that hosts educational materials, from Week 1 through Week 16	Week 16
Other	Number of interactions with lifestyle coach	Count of total interactions from Week 1 to Week 12	Week 12
Other	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
Other	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in self-reported blood pressure	blood pressure, self-reported weekly	Weekly, Weeks 0-12