Diabetes Mellitus, Type 2, PreDiabetes
Conditions
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
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.
Interventions
BEHAVIORALEducation
Healthy-lifestyle and diabetes-related virtual education (text and videos)
BEHAVIORALMeal delivery
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
BEHAVIORALLifestyle coaching
calls with coach and/or nutritionist, access to Facebook community support group
Sponsors
UnitedHealth Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean glucose time in range from baseline at Week 6 | 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 |
| Change in mean glucose time in range from baseline at Week 16 | 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 |
| Change in mean glucose time in range from baseline at Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood test results from baseline | 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 |
| Change in CGM-derived glucose features from baseline | 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 |
| Change in self-reported waist-to-hip ratio | Weekly, Weeks 0-12 | waist circumference, hip circumference, self-reported weekly; calculated by dividing the waist circumference by the hip circumference |
| Change in self-reported blood pressure | Weekly, Weeks 0-12 | blood pressure, self-reported weekly |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of interactions with lifestyle coach | Week 12 | Count of total interactions from Week 1 to Week 12 |
| Percentage of tasks completed | Week 16 | Usage stats from website that hosts educational materials, from Week 1 through Week 16 |
| Change from baseline in abbreviated Medical Outcomes Study Sleep Scale | 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 |
| Change from baseline in modified Yale Food Addiction Scale score at Week 6, Week 13 | 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 |
| Visits to site | Week 16 | Usage stats from website that hosts educational materials, from Week 1 through Week 16 |
Countries
United States
Outcome results
None listed