BeWell24: Smartphone-based Diabetes Prevention in the VA

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

BeWell24: Smartphone-based Diabetes Prevention in the VA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202277
• Other study ID #: 1R18DK109516
• Status: Completed
• Phase: N/A
• Start date: September 17, 2017
• Est. completion date: December 14, 2019

Study information

• Verified date: May 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 14, 2019
• Est. primary completion date: December 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Phoenix VA Healthcare System	Phoenix	Arizona
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Phoenix VA Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Circulating levels of Hemoglobin A1c	9 months
Primary	Fasting glucose	Fasting levels of glucose	9 months
Secondary	Sleep duration (minutes/night) measured by wrist actigraphy	Sleep duration (measured by wrist actigraphy)	9 months
Secondary	Sedentary behavior (minutes/day) measured by wrist actigraphy	Measure of sedentary time (measured by wrist actigraphy)	9 months
Secondary	Moderate-vigorous physical activity (minutes/day) measured by wrist actigraphy	Measure of moderate-vigorous physical activity (measured by wrist actigraphy)	9 months
Secondary	Dietary quality measured by the NCI dietary factor screener	Self-reported dietary quality	9 months