BeWell24: Smartphone-based Diabetes Prevention in the VA

Type 2 diabetes (T2D) is a national epidemic and current lifestyle programs and medications are not effectively managing the crisis. This project aims to test a novel smartphone-delivered intervention that simultaneously targets multiple health behaviors (i.e., sleep, sedentary behavior, physical activity,dietary intake) within clinical settings at a large Veteran Health Administration regional hospital. If effective, this project has potential for large-scale implementation nationwide through the VA healthcare system and broad applicability for other populations at T2D risk as well as other disorders.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: BeWell24 smartphone app; Behavioral: Health education app

Detailed Description

Type 2 diabetes (T2D) affects 26 million Americans and "prediabetes" affects 86 million more. If this epidemic is not addressed immediately, 23% of Americans will have T2D by 2030. Current lifestyle programs to prevent diabetes are complex to deliver, costly, and have limited scalability. Medications do not clearly modify the disease process and have a number of side effects. New approaches are needed that can address this epidemic on a population scale. mHealth technologies (e.g., smartphones) are deeply integrated into our lives and can target the daily lifestyle behaviors that underpin the T2D epidemic. The Veterans Health Administration (VHA) is an ideal setting to test mHealth approaches because they are at the forefront of harnessing smartphone technologies to deliver care with the advent of the "VA App Store." As the nation's largest integrated healthcare system, VHA has a central dissemination infrastructure to deliver smartphone interventions to over 5.5 million Veterans. BeWell24, an adaptive and multicomponent smartphone "app" was developed based on the unique needs and desires of US Veterans and VHA clinical teams. BeWell24 targets behaviors across the 24 hours - sleep, sedentary behavior, and more active behaviors - and preliminary data suggest reductions in fasting glucose among prediabetics of 12.3% in just 8 weeks of use. A dietary component will be added to the app to further enhance the potency of the intervention. The objective now is to test whether the delivery and integration of this app into routine clinical care settings can improve glycemic control over 9 months. A randomized controlled trial of 120 prediabetic Veterans is proposed. The first aim is to test whether BeWell24 significantly improves glycemic control (reduce fasting glucose and HbA1c) over 9 months relative to usual care. Objectively-measured changes is targeted behaviors (sleep, sedentary behavior, physical activity, and dietary intake) and other key cardiometabolic biomarkers (weight/body fat, blood pressure, lipids, insulin, and hs-CRP) will also be explored. The second and third aims are to assess factors impacting scalability of BeWell24 from patient and provider perspectives to optimize opportunities for large-scale dissemination if efficacious. Program reach/retention, app usage, treatment acceptability, program costs, and clinical integration factors will be studied. Unique features of this proposal are the rigorous cluster-randomized design; testing in a highly integrated, nationwide, clinical setting; and use of a highly sophisticated smartphone platform uniquely designed for the population and targets multiple health behaviors impacting T2D risk. The long-term goal is to establish an effective diabetes prevention program among Veterans that can be used to complement and enhance existing clinical support. If effective, this approach could be rapidly scaled to Veterans nationwide and could have broad applicability for other populations at disparate T2D risk as well as other disorders.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Phoenix VA Healthcare System
    • Tempe, Arizona, United States, 85281
      • Arizona State 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:

• Veterans ages 18 and older
• Regularly use an appropriate Apple (iOS6 or higher) or Android (2.3 or higher) smartphone or tablet device
• Risk for "prediabetes" based upon clinician judgment - clinicians may rely on laboratory data review in the prior 12 months including: (a) HbA1c 5.7-6.4%; and (b) glucose, HDL-cholesterol, triglycerides, and weight

Exclusion Criteria:

• long distance or insufficient transportation to the Veterans hospital to make participation in quarterly visits difficult;
• severe personal, health, cognitive or psychological conditions that prevent participation or severely limit lifestyle changes
• limited physical mobility, untreated sleep disorder, or other underlying disorder that requires treatment or would make lifestyle change contraindicated
• current participation in other diet, weight loss, or lifestyle programs
• recent or imminent changes in medications that would substantially alter glucose metabolism (e.g., steroids, anti-depressive medications associated with weight gain)
• recent weight gain or loss of more than 10 kg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BeWell24 smartphone app; Smartphone app, linked with commercial activity monitor, to support lifestyle changes in physical activity, sleep, sedentary behavior, and dietary intake.	Behavioral: BeWell24 smartphone app; This app delivers an evidence-based suite of lifestyle interventions targeting behavior change in sleep, sedentary behavior, physical activity, and dietary intake. The app connects with a commercially available activity monitor to provide real-time feedback on behaviors over time.
Active Comparator: Health education smartphone app; Smartphone app with basic health education content, designed to control for non-specific treatment effects and match for smartphone app novelty.	Behavioral: Health education app; This app delivers basic health education and hygiene content related to sleep, sedentary behavior, physical activity, and dietary intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Circulating levels of Hemoglobin A1c	9 months
Fasting glucose	Fasting levels of glucose	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep duration (minutes/night) measured by wrist actigraphy	Sleep duration (measured by wrist actigraphy)	9 months
Sedentary behavior (minutes/day) measured by wrist actigraphy	Measure of sedentary time (measured by wrist actigraphy)	9 months
Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy	Measure of moderate-vigorous physical activity (measured by wrist actigraphy)	9 months
Dietary quality measured by the NCI dietary factor screener	Self-reported dietary quality	9 months

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: Phoenix VA Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2017
• Primary Completion (Actual): December 14, 2019
• Study Completion (Actual): December 14, 2019

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: physical activity, sleep, sedentary behavior, dietary intake, smartphone
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 1R18DK109516 (U.S. NIH Grant/Contract)

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