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Completed

NCT Number: NCT04810026

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

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Key information

Conditions

PreDiabetes Behavior Body Weight Communication Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Information Seeking Behavior Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OptumLabs

Minnetonka, Minnesota, 55343, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Behavioral

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

Other names: diabetes self-management education, healthy-lifestyle education

Meal Delivery

Behavioral

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

Other names: Nutrition for Longevity meals, Longevity Diet

Lifestyle Coaching

Behavioral

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

Other names: Longevity Program

Primary outcomes

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

    Time frame: Week 0 and 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

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

    Time frame: Week 0 and 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

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

    Time frame: Week 0 and 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 outcomes

  1. Change in CGM-derived glucose features from baseline

    Time frame: Week 0, Week 6, Week 12, and Week 16

    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

  2. Change in blood test results from baseline

    Time frame: Week 0, Week 12

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

  3. Change in self-reported waist-to-hip ratio

    Time frame: Weekly, Weeks 0-12

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

  4. Change in self-reported blood pressure

    Time frame: Weekly, Weeks 0-12

    blood pressure, self-reported weekly

Other outcomes

  1. Visits to site

    Time frame: Week 16

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

  2. Percentage of tasks completed

    Time frame: Week 16

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

  3. Number of interactions with lifestyle coach

    Time frame: Week 12

    Count of total interactions from Week 1 to Week 12

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

    Time frame: Week 0, 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

  5. Change from baseline in abbreviated Medical Outcomes Study Sleep Scale

    Time frame: Week 0, Week 13

    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

Sponsors and collaborators

Lead sponsor

UnitedHealth Group

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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