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

Not Applicable

Completed

• Conditions: PreDiabetes

• Registration Number: NCT03865342
• Lead Sponsor: Noom Inc.

Brief Summary

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

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 Timeline

• Study Start: 2016-09
• Primary Completion: 2018-06-25
• Study Completion: 2018-06-25
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-05
• Study First Posted: 2019-03-06
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in weight	Baseline, 6, and 12 months	Body weight recorded during follow-up appointments at the medical clinic.

Secondary Outcome Measures

Name	Time	Method
Change in hemoglobin A1c	Baseline, 6, and 12 months	Hemoglobin A1c measured during follow-up appointments at the medical clinic.

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States