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| Name | Class |
|---|---|
| Stony Brook University | OTHER |
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This study will test the weight loss efficacy of a mobile diabetes prevention program intervention. Half of the sample of prediabetic adults will receive the virtual DPP and half will receive usual medical care.
There were 84.1 million people with pre-diabetes, 30.3 million people with diagnosed and 7.2 million with undiagnosed diabetes in the United States in 2015, and nearly 2 million are diagnosed with it every year. By 2050, the CDC estimates that 1 in every 3 people globally will have diabetes, a leading cause of death and disability.
The primary goal of this study is to evaluate the efficacy of the Noom Coach Diabetes Prevention Program mobile platform versus usual medical care. The best intervention to date for prediabetes is the Centers for Disease Control and Prevention's Diabetes Prevention Program, yet there is limited research investigating a mobile-based delivery of the DPP. Pre-diabetes is often discovered during routine medical visitation/annual screening (usual care), but face-to-face time with clinicians is often limited. Exploring novel ways, such as mHealth interventions to empower patients to pursue lifestyle change and prevent or delay diabetes onset is critical to addressing the growing diabetes epidemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noom Coach DPP | Experimental | Individuals will receive special instructions on how to use the app and will self-monitor their weight, exercise and receive daily DPP core content through the app over 16 weeks plus guidance from a coach, and will thereafter receive post-core DPP content up to 52 weeks. |
|
| Usual Care | No Intervention | The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period plus a paper version of the DPP curriculum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noom Coach DPP | Behavioral | Subjects receiving the smartphone app will receive the DPP core curriculum for 16 weeks and then the post-core curriculum for 36 weeks through the app. The Noom mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve DPP goals. The participant can log their food intake, weight, steps, exercise, in addition to participating in the DPP group interaction through the application. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Body weight recorded during follow-up appointments at the medical clinic. | Baseline, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin A1c | Hemoglobin A1c measured during follow-up appointments at the medical clinic. | Baseline, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in work productivity | Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI)
|
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua D Miller, MD, MPH | Stony Brook University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32459631 | Derived | Toro-Ramos T, Michaelides A, Anton M, Karim Z, Kang-Oh L, Argyrou C, Loukaidou E, Charitou MM, Sze W, Miller JD. Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 8;8(7):e17842. doi: 10.2196/17842. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D015431 | Weight Loss |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Baseline, 6, and 12 months |
| Change in quality of life | Healthy Days Core Module (CDC HRQOL- 4)
| Baseline, 6, and 12 months |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |