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

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

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Behavioral: Noom Coach DPP

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 Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in work productivity	Work Productivity and Activity Impairment Questionnaire: General Health V2.0 (WPAI); Are you currently employed (working for pay)?; During the past seven days, how many hours did you miss from work because of your health problems?; During the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; During the past seven days, how many hours did you actually work?; During the past seven days, how much did your health problems affect your productivity while you were working? (0-10, higher is more impact); During the past seven days, how much did your health problems affect your ability to do your regular daily activities, other than work at a job? By regular activities, we mean the usual activities you do, such as work around the house, shopping, childcare, exercising, studying, etc.(0-10, higher is more impact)	Baseline, 6, and 12 months
Change in quality of life	Healthy Days Core Module (CDC HRQOL- 4); Would you say that in general your health is excellent, very good, good, fair or poor? Excellent Good Fair Poor; Now thinking about your physical health, which includes physical illness and injury, how many days during the past 30 days was your physical health not good?; Now thinking about your mental health, which includes stress, depression, and problems with emotions, how many days during the past 30 days was your mental health not good?; During the past 30 days, approximately how many days did poor physical or mental health keep you from doing your usual activities, such as self-care, work, or recreation?	Baseline, 6, and 12 months

Collaborators and Investigators

• Sponsor: Noom Inc.
• Collaborators: Stony Brook University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: mHealth; weight loss; body weight; Diabetes Prevention Program; behavioral interventions
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 695755-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No