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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Diabetes Mellitus, Type 2
- 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 group | Role | What they receive |
|---|---|---|
| BeWell24 smartphone app | Experimental | Smartphone 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 app | Active comparator | Smartphone 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.
HbA1c
Circulating levels of Hemoglobin A1c
Measured: 9 months
Fasting glucose
Fasting levels of glucose
Measured: 9 months
Secondary outcomes (4)
Sleep duration (minutes/night) measured by wrist actigraphy
Sleep duration (measured by wrist actigraphy)
Measured: 9 months
Sedentary behavior (minutes/day) measured by wrist actigraphy
Measure of sedentary time (measured by wrist actigraphy)
Measured: 9 months
Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy
Measure of moderate-vigorous physical activity (measured by wrist actigraphy)
Measured: 9 months
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.
- First posted28 Jun 2017
- Study start17 Sep 2017
- Primary completion14 Dec 2019
- Study completion14 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix VA Health Care System
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BeWell24: Smartphone-based Diabetes Prevention in the VA
- ClinicalTrials.gov ID
- NCT03202277
- Acronym / sponsor ID
- 1R18DK109516
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- physical activity, sleep, sedentary behavior, dietary intake, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Phoenix VA Health Care System
- Study start
- 17 Sep 2017 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 14 Dec 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| BeWell24 smartphone app | Experimental | Behavioral: BeWell24 smartphone appSmartphone app, linked with commercial activity monitor, to support lifestyle changes in physical activity, sleep, sedentary behavior, and dietary intake. |
| Health education smartphone app | Active comparator | Behavioral: Health education appSmartphone app with basic health education content, designed to control for non-specific treatment effects and match for smartphone app novelty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeWell24 smartphone appThis 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. | Behavioural | BeWell24 smartphone app |
| Health education appThis app delivers basic health education and hygiene content related to sleep, sedentary behavior, physical activity, and dietary intake. | Behavioural | Health education smartphone app |
Primary outcome
HbA1c
Time frame: 9 months
Circulating levels of Hemoglobin A1c
Fasting glucose
Time frame: 9 months
Fasting levels of glucose
4 secondary outcomes
Sleep duration (minutes/night) measured by wrist actigraphy
Time frame: 9 months
Sedentary behavior (minutes/day) measured by wrist actigraphy
Time frame: 9 months
Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy
Time frame: 9 months
Dietary quality measured by the NCI dietary factor screener
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.