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Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs

NCT04712383 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2022-02-21

No results posted yet for this 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.).

Conditions

  • Health Behavior

Interventions

COMBINATION_PRODUCT

Fitbit Care intervention arm

Entire suite of Fitbit Care.

Sponsors & Collaborators

  • Fitbit LLC

    collaborator INDUSTRY

  • Massachusetts eHealth Initiative

    collaborator UNKNOWN

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Steven Bird, MD · UMass Memorial Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2022-01-18
Completion
2022-01-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712383 on ClinicalTrials.gov