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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Education only | Active Comparator | Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks |
|
| Group 2: Education and Meals | Experimental | 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 3: Education, Meals, Coaching | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Healthy-lifestyle and diabetes-related virtual education (text and videos) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in blood test results from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Visits to site | Usage stats from website that hosts educational materials, from Week 1 through Week 16 | Week 16 |
| Percentage of tasks completed | Usage stats from website that hosts educational materials, from Week 1 through Week 16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katlyn A Fleming, PhD | UnitedHealth Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OptumLabs | Minnetonka | Minnesota | 55343 | United States |
All of the individual participant data (IPD) that has been collected during the trial and de-identified
Immediately following publication, no end date
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.
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003924 | Diabetes Mellitus, Type 2 |
| D057226 | Information Seeking Behavior |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
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| Meal delivery | Behavioral | breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles |
|
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| Lifestyle coaching | Behavioral | calls with coach and/or nutritionist, access to Facebook community support group |
|
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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 |
| 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 |
| Change in self-reported blood pressure | blood pressure, self-reported weekly | Weekly, Weeks 0-12 |
| Week 16 |
| Number of interactions with lifestyle coach | Count of total interactions from Week 1 to Week 12 | Week 12 |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D003142 | Communication |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |