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

NCT ID: NCT04810026

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2021-10-26

Brief Summary

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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

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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.

Conditions

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PreDiabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: Education only

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

Group Type ACTIVE_COMPARATOR

Education

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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

Meal delivery

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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

Meal delivery

Intervention Type BEHAVIORAL

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

Lifestyle coaching

Intervention Type BEHAVIORAL

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

Interventions

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Education

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

Intervention Type BEHAVIORAL

Meal delivery

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

Intervention Type BEHAVIORAL

Lifestyle coaching

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

Intervention Type BEHAVIORAL

Other Intervention Names

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diabetes self-management education healthy-lifestyle education Nutrition for Longevity meals Longevity Diet Longevity Program

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UnitedHealth Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Shane Hoversten

Senior Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katlyn A Fleming, PhD

Role: PRINCIPAL_INVESTIGATOR

UnitedHealth Group

Locations

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OptumLabs

Minnetonka, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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2020-0068

Identifier Type: -

Identifier Source: org_study_id

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