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

University of Massachusetts, Worcester

Status: Completed

Conditions: Health Behavior

Treatments: Combination Product: Fitbit Care intervention arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04712383

H00021669

2020 - MeHI - 01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.).

Enrollment: 597 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Employed by UMassMemorial Health Care
• Receive benefits from UMassMemorial Health Care
• Have a smartphone

Exclusion criteria

• Pregnant
• Unable to consent
• Non-English speaking

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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597 participants in 2 patient groups

Fitbit Care intervention arm

Experimental group

Description:

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.

Treatment:

Combination Product: Fitbit Care intervention arm

Fitbit study control arm

No Intervention group

Description:

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