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

NCT04712383 | Completed

• 2 other identifiers: H000216692020 - MeHI - 01
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

health behavior; fitness

Outcome Measures

Primary Outcomes (8)

• Change in total medical expenditures for calendar year 2020 to 2021

  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.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screening including body weight at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screenings including waist circumference at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screenings including blood pressure at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screenings including LDL cholesteral at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screenings including HDL cholesteral at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in Biometric Outcomes

  Participants will have biometric screenings including hemoglobin A1c at the beginning and end of the study that will be used to determine the change in that biometric over the course of the study, and the results will be compared between the intervention and control groups.

  12 months

• Changes in self-reported health behaviors and levels of motivation and confidence in making improvements

  Participants will complete a health behavior survey (addresses overall health, nutrition, activity, sleep, mindfulness, alcohol, and smoking behaviors as well as levels of motivation and confidence in making improvements) at the beginning of the study and every three months until the end of the study. This will be used to determine changes in behaviors, motivation, and confidence over the course of the study, and the results will be compared between the intervention and control groups. This is not done via a scale, but answers range from Strongly agree, to Somewhat agree, to Neither agree nor disagree, to Somewhat disagree, to Strongly disagree.

  3 months, 6 months, 9 months, and 12 months

Secondary Outcomes (8)

• Proportion of participants achieving target biometric outcomes

  12 months

• Proportion of participants achieving categorical improvement in biometric outcomes

  12 months

• Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes

  12 months

• Changes in metrics collected by Fitbit devices and Fitbit app

  weekly and totaled over 12 months

• Changes in metrics collected by Fitbit devices and Fitbit app

  weekly and totaled over 12 months

Study Arms (2)

Fitbit Care intervention arm

EXPERIMENTAL

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.

Combination Product: Fitbit Care intervention arm

Fitbit study control arm

NO INTERVENTION

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

Interventions

Fitbit Care intervention arm COMBINATION_PRODUCT

Entire suite of Fitbit Care.

Fitbit Care intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant
• Unable to consent
• Non-English speaking

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Fitbit LLC: collaborator
• Massachusetts eHealth Initiative: collaborator

Study Sites (1)

UMassMemorial Health Care

Worcester, Massachusetts, 01655-0002, United States

Location

Related Publications (1)

• 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.

  PMID: 39475852 DERIVED

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Steven Bird, MD

  UMass Memorial Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: January 13, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)