Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention (DPP) Program: a Randomized Trial

Conditions
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PreDiabetes

Intervention / Treatment
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* Behavioral: Noom Coach DPP


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: English-speaking 18 years of age and older Referral from the patient's physician Hemoglobin A1C: 5.7 - 6.4 within the 3 months prior to enrollment Own a smartphone (Apple or Android) Exclusion criteria: Recent weight loss (by patient report, >5 lbs in the 6 months preceding enrollment visit) previous diagnosis of type 1 or type 2 diabetes serious or persistent mental illnesses more than 72 hours of hospitalization in the last 30 days Enrollment in a structured weight-loss program currently or within the 1 month preceding study enrollment Pregnant Currently nursing Have given birth within the past 3 months Has been discouraged by a physician to enroll in a DPP program

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noom Coach DPP<br>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. | Behavioral: Noom Coach DPP<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Body weight recorded during follow-up appointments at the medical clinic. | Baseline, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemoglobin A1c | Hemoglobin A1c measured during follow-up appointments at the medical clinic. | Baseline, 6, and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Diabetes Prevention Program, weight loss, body weight, behavioral interventions