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Diabetes Mellitus, Type 2NCT03202277

BeWell24: Smartphone-based Diabetes Prevention in the VA

A study testing BeWell24 smartphone app and Health education app in people with Diabetes Mellitus, Type 2, run by Arizona State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
BeWell24 smartphone app and Health education app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesUnited States
Study dates
17 Sep 2017to 14 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Phoenix VA Healthcare System

    Phoenix, Arizona, 85012

  • Arizona State University

    Tempe, Arizona, 85281

Other trials in United States

About this study

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.

Read the 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.

Being tested
BeWell24 smartphone app, Health education app
Keywords
physical activity, sleep, sedentary behavior, dietary intake, smartphone
Medical subject headings
Diabetes Mellitus, Type 2, Motor Activity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BeWell24 smartphone appBehavioural

    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.

  • Health education appBehavioural

    This app delivers basic health education and hygiene content related to sleep, sedentary behavior, physical activity, and dietary intake.

Study groups in NCT03202277
Study groupRoleWhat they receive
BeWell24 smartphone appExperimentalSmartphone app, linked with commercial activity monitor, to support lifestyle changes in physical activity, sleep, sedentary behavior, and dietary intake.
Receives: Behavioral: BeWell24 smartphone app
Health education smartphone appActive comparatorSmartphone app with basic health education content, designed to control for non-specific treatment effects and match for smartphone app novelty.
Receives: Behavioral: Health education app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Circulating levels of Hemoglobin A1c

    Measured: 9 months

  2. Fasting glucose

    Fasting levels of glucose

    Measured: 9 months

Secondary outcomes (4)
  1. Sleep duration (minutes/night) measured by wrist actigraphy

    Sleep duration (measured by wrist actigraphy)

    Measured: 9 months

  2. Sedentary behavior (minutes/day) measured by wrist actigraphy

    Measure of sedentary time (measured by wrist actigraphy)

    Measured: 9 months

  3. Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy

    Measure of moderate-vigorous physical activity (measured by wrist actigraphy)

    Measured: 9 months

  4. Dietary quality measured by the NCI dietary factor screener

    Self-reported dietary quality

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study start17 Sep 2017
  3. Primary completion14 Dec 2019
  4. Study completion14 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202277
Sponsor's protocol ID
1R18DK109516
Status last verified
May 2020
First submitted
23 Jun 2017
Last updated
11 May 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BeWell24 smartphone app and Health education app in people with Diabetes Mellitus, Type 2, run by Arizona State University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.

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