PreDiabetesNCT04810026
Transform Type 2: Examining Meal-Delivery and Education for Diabetes Self-Care
A study testing Education, Meal delivery and Lifestyle coaching in people with PreDiabetes and Diabetes Mellitus, Type 2, run by UnitedHealth Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Education, Meal delivery and Lifestyle coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and 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.
Read the 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.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Being tested
- Education, Meal delivery, Lifestyle coaching
- 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
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Information Seeking Behavior, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Also called diabetes self-management education, healthy-lifestyle education
Healthy-lifestyle and diabetes-related virtual education (text and videos)
Meal deliveryBehavioural
Also called Nutrition for Longevity meals, Longevity Diet
breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
Lifestyle coachingBehavioural
Also called Longevity Program
calls with coach and/or nutritionist, access to Facebook community support group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Education |
| 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 Receives: Behavioral: Education; Behavioral: Meal delivery |
| 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 Receives: Behavioral: Education; Behavioral: Meal delivery; Behavioral: Lifestyle coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Week 0 and Week 16
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: Weekly, Weeks 0-12
Change in self-reported blood pressure
blood pressure, self-reported weekly
Measured: Weekly, Weeks 0-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start3 May 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- UnitedHealth Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Shane Hoversten, UnitedHealth Group
- Investigators
- Katlyn A Fleming, PhD, Principal investigator, UnitedHealth Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810026
- Sponsor's protocol ID
- 2020-0068
- Status last verified
- Feb 2022
- First submitted
- 12 Mar 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data (IPD) that has been collected during the trial and de-identified
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transform Type 2: Examining How Meal-Delivery and Education Resources Affect Prediabetes and Type 2 Diabetes Symptoms and Self-Care
- ClinicalTrials.gov ID
- NCT04810026
- Acronym / sponsor ID
- 2020-0068
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Keywords
- diabetes mellitus, type 2, information seeking behavior, waist-hip ratio, blood pressure, weight, prediabetes, glycemic control, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- UnitedHealth GroupIndustry (pharma, biotech, devices)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Education only | Active comparator | Behavioral: EducationPush notifications for online diabetes self-management education for 12 weeks, passive access to lifestyle education for 16 weeks |
| Group 2: Education and Meals | Experimental | Behavioral: Education, Behavioral: Meal deliveryMeal 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 | Behavioral: Education, Behavioral: Meal delivery, Behavioral: Lifestyle coachingMeal 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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+
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationAlso: diabetes self-management education, healthy-lifestyle educationHealthy-lifestyle and diabetes-related virtual education (text and videos) | Behavioural | Group 1: Education only, Group 2: Education and Meals, Group 3: Education, Meals, Coaching |
| Meal deliveryAlso: Nutrition for Longevity meals, Longevity Dietbreakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles | Behavioural | Group 2: Education and Meals, Group 3: Education, Meals, Coaching |
| Lifestyle coachingAlso: Longevity Programcalls with coach and/or nutritionist, access to Facebook community support group | Behavioural | Group 3: Education, Meals, Coaching |
Primary outcome
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
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
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
4 secondary outcomes
Change in CGM-derived glucose features from baseline
Time frame: Week 0, Week 6, Week 12, and Week 16
Change in blood test results from baseline
Time frame: Week 0, Week 12
Change in self-reported waist-to-hip ratio
Time frame: Weekly, Weeks 0-12
Change in self-reported blood pressure
Time frame: Weekly, Weeks 0-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data (IPD) that has been collected during the trial and de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katlyn A Fleming, PhD principal investigator
UnitedHealth Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Meal delivery and Lifestyle coaching in people with PreDiabetes and Diabetes Mellitus, Type 2, run by UnitedHealth Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean glucose time in range from baseline at Week 6 (time frame: Week 0 and Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.