BeWell24: Smartphone-based Diabetes Prevention in the VA

May 8, 2020 updated by: Arizona State University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 9 months
Circulating levels of Hemoglobin A1c
9 months
Fasting glucose
Time Frame: 9 months
Fasting levels of glucose
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep duration (minutes/night) measured by wrist actigraphy
Time Frame: 9 months
Sleep duration (measured by wrist actigraphy)
9 months
Sedentary behavior (minutes/day) measured by wrist actigraphy
Time Frame: 9 months
Measure of sedentary time (measured by wrist actigraphy)
9 months
Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy
Time Frame: 9 months
Measure of moderate-vigorous physical activity (measured by wrist actigraphy)
9 months
Dietary quality measured by the NCI dietary factor screener
Time Frame: 9 months
Self-reported dietary quality
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arizona State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Phoenix VA Health Care System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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