Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
NCT ID: NCT04712383
Last Updated: 2022-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
597 participants
INTERVENTIONAL
2021-01-13
2022-01-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis is that those employees in the intervention group will experience improved results compared to those in the control group. It is believed that they will have improved health behaviors, improved biometrics, and lower total healthcare costs (fewer complications, fewer hospitalizations, etc.).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Corporate Wellness Program
NCT04308382
Adherence to Health Coaching with Wearable Devices: Enhancing Patient Engagement and Outcomes
NCT06525337
Assessing the Impact of myHealth Rewards Enrollment Emails
NCT03965754
Assessing the Impact of myHealth Rewards New Hire Enrollment Emails
NCT04047342
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
NCT01346189
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fitbit Care intervention arm
The experimental arm will receive the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the experimental arm will also be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence.
Fitbit Care intervention arm
Entire suite of Fitbit Care.
Fitbit study control arm
Participants in the control arm will have access to standard healthcare benefits available to all employees, but will not have access to any of the Fitbit Care interventions
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fitbit Care intervention arm
Entire suite of Fitbit Care.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receive benefits from UMassMemorial Health Care
* Have a smartphone
Exclusion Criteria
* Unable to consent
* Non-English speaking
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fitbit LLC
INDUSTRY
Massachusetts eHealth Initiative
UNKNOWN
University of Massachusetts, Worcester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven Bird
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Bird, MD
Role: PRINCIPAL_INVESTIGATOR
UMass Memorial Healthcare
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UMassMemorial Health Care
Worcester, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Howard-Wilson S, Ching J, Gentile S, Ho M, Garcia A, Ayturk D, Lazar P, Hammerquist N, McManus D, Barton B, Bird S, Moore J, Soni A. Efficacy of a Multimodal Digital Behavior Change Intervention on Lifestyle Behavior, Cardiometabolic Biomarkers, and Medical Expenditure: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 30;13:e50378. doi: 10.2196/50378.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020 - MeHI - 01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H00021669
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.