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

NCT ID: NCT03865342

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-06-25

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Noom Coach DPP

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.

Group Type: EXPERIMENTAL

Noom Coach DPP

Intervention Type: 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.

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Noom Coach DPP

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stony Brook University

OTHER

Sponsor Role: collaborator

Noom Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua D Miller, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University Medical Center

Locations

Stony Brook University

Stony Brook, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32459631 (View on PubMed)

Other Identifiers

695755-6

Identifier Type: -

Identifier Source: org_study_id