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

Noom Inc.202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

202

Conditions

PreDiabetes

Interventions

Noom Coach DPPBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stony Brook University

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Change in weight

Body weight recorded during follow-up appointments at the medical clinic.

Time frame: Baseline, 6, and 12 months

Secondary Outcomes

Change in hemoglobin A1c

Hemoglobin A1c measured during follow-up appointments at the medical clinic.

Time frame: Baseline, 6, and 12 months

Data from ClinicalTrials.gov

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