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

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865342
• Other study ID #: 695755-6
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 25, 2018

Study information

• Verified date: April 2023
• Source: Noom Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

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.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Noom Inc.	Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	Change in weight	Body weight recorded during follow-up appointments at the medical clinic.	Baseline, 6, and 12 months
Secondary	Change in hemoglobin A1c	Hemoglobin A1c measured during follow-up appointments at the medical clinic.	Baseline, 6, and 12 months