Clinical trial NCT03865342: Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program
Official title: Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention (DPP) Program: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: mHealth
Diabetes Prevention Program
weight loss
body weight
behavioral interventions
Lead sponsor: Noom Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stony Brook University
First posted: 2019-03-06
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in weight
timeFrame: Baseline, 6, and 12 months
Secondary outcomes:
measure: Change in hemoglobin A1c
timeFrame: Baseline, 6, and 12 months
Other outcomes:
measure: Change in work productivity
timeFrame: Baseline, 6, and 12 months
measure: Change in quality of life
timeFrame: Baseline, 6, and 12 months
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University Medical Center
name: Joshua D Miller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.