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NCT04712383 · ClinicalTrials.gov registry record · NA
Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
A NA study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- NA
- Development phase
- 597
- Enrollment target
NCT04712383: Completed NA study, sponsored by University of Massachusetts, Worcester.
NCT04712383 is a NA study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 597 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04712383, a NA study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- NA
- Development phase
- 597 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees of UMass Memorial Health Care in which 350 participants (control group) receive standard wellness and medical benefits and services for UMass Memorial Health Care employees and in which 350 participants (intervention group) receive these same standard benefits and services as well as the full Fitbit Care product suite (Fitbit wrist-worn device, Fitbit connected weight scale, and Fitbit Premium + Health Coaching service). Participants in the intervention group will be offered support in improving health behaviors that are important to them, including activity, nutrition, sleep, stress management, and medication adherence. They will also be offered support in tying these behaviors to their health goals, including blood pressure management, blood sugar management, cholesterol management, weight loss, smoking cessation, etc. 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.).
Primary Outcome
Change in total medical expenditures from calendar year 2020 to 2021 Participant insurance claim information will be analyzed to determine the change in total medical expenditures from 2020 to 2021 and the results will be compared between the intervention and control groups.
Interventions
- COMBINATION_PRODUCT Fitbit Care intervention arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 597 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2022-01-18 |
| Phase | NA |
What the finished NCT04712383 record still lists
NCT04712383 is an interventional study that assigns participants to a tested intervention. The registered 597 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Fitbit Care intervention arm is the first listed.
NCT04712383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04712383 about?
NCT04712383 is a clinical study titled "Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs". The purpose of this study is to measure the impact of consumer-grade wearable health devices and behavior change support services, including health coaching, on health behaviors, biometrics, and healthcare costs. The study will be a randomized controlled trial with 700 participants who are employees...
What is the current status of trial NCT04712383?
This trial is currently completed. It is a NA study. The enrollment target is 597 participants. The study started on 2021-01-13. Estimated completion is 2022-01-18.
What interventions are being tested in trial NCT04712383?
The interventions under investigation include: Fitbit Care intervention arm (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04712383?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04712383's enrollment target sits among peer trials
597 174th of 2000 higher than 1,827 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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