An interventional study of Education and Meal delivery in PreDiabetes and Diabetes Mellitus, Type 2, sponsored by UnitedHealth Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by UnitedHealth Group · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 41 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →UnitedHealth Group is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Push notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks
Behavioral: Education
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
Behavioral: Education · Behavioral: Meal delivery
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
Behavioral: Education · Behavioral: Meal delivery · Behavioral: Lifestyle coaching
Healthy-lifestyle and diabetes-related virtual education (text and videos)
Also known as: diabetes self-management education, healthy-lifestyle education
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
Also known as: Nutrition for Longevity meals, Longevity Diet
calls with coach and/or nutritionist, access to Facebook community support group
Also known as: Longevity Program
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
Time frame: 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
Time frame: 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
Time frame: Week 0 and Week 16
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
Time frame: Week 0, Week 6, Week 12, and Week 16
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
Time frame: 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
Time frame: Weekly, Weeks 0-12
Change in self-reported blood pressure
blood pressure, self-reported weekly
Time frame: Weekly, Weeks 0-12
Visits to site
Usage stats from website that hosts educational materials, from Week 1 through Week 16
Time frame: Week 16
Percentage of tasks completed
Usage stats from website that hosts educational materials, from Week 1 through Week 16
Time frame: Week 16
Number of interactions with lifestyle coach
Count of total interactions from Week 1 to Week 12
Time frame: 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
Time frame: 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
Time frame: Week 0, Week 13
Plan to share: Yes — All of the individual participant data (IPD) that has been collected during the trial and de-identified
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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UnitedHealth Group