Health BehaviorNCT04712383
Impact of Wearable Health Devices and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
A study testing Fitbit Care intervention arm in people with Health Behavior, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Fitbit Care intervention arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 597 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 18 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed by UMassMemorial Health Care
- Receive benefits from UMassMemorial Health Care
- Have a smartphone
Who cannot join
- Pregnant
- Unable to consent
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
UMassMemorial Health Care
Worcester, Massachusetts, 01655-0002
About this study
Official title: Impact of Wearable Health Devices and Health 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 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
- Being tested
- Fitbit Care intervention arm
- Keywords
- health behavior, fitness
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit Care intervention armCombination product
Entire suite of Fitbit Care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (8)
Proportion of participants achieving target biometric outcomes
Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who reach standard clinical target values, and the percentage of participants will be compared between the intervention and control groups.
Measured: 12 months
Proportion of participants achieving categorical improvement in biometric outcomes
Participants will have biometric screenings (including body weight, waist circumference, blood pressure, hemoglobin A1c, and LDL and HDL cholesterol) at the beginning and end of the study that will be used to determine, for each biometric, the percentage of participants in each study arm who improve at least one clinical category (for example, from stage 2 hypertension to stage 1 hypertension, and the percentage of participants will be compared between the intervention and control groups.
Measured: 12 months
Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
Participant responses to the health behavior survey (behaviors as well as levels of motivation and confidence in making improvements) will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.
Measured: 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
For participants in the intervention group, changes in steps taking collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
Measured: weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
For participants in the intervention group, changes in active zone minutes collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
Measured: weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
For participants in the intervention group, changes in hours of sleep collected by Fitbit devices and in the Fitbit app will be analyzed over the course of the study.
Measured: weekly and totaled over 12 months
Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
For participants in the intervention group, changes in metrics collected by Fitbit devices and in the Fitbit app will be analyzed for correlations with changes in total medical expenditures and biometric outcomes.
Measured: 12 months
Correlations between engagement with health coach and total medical expenditure and biometric outcomes
For participants in the intervention group, engagement with the health coach in the Fitbit app will be measured based on the number of text messages and interactions with the health coaching action plan and analyzed for correlations with changes in total medical expenditures and biometric outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start13 Jan 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 597 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Fitbit LLC, Massachusetts eHealth Initiative
- Responsible party
- Principal investigator, Steven Bird, University of Massachusetts, Worcester
- Investigators
- Steven Bird, MD, Principal investigator, UMass Memorial Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712383
- Sponsor's protocol ID
- H00021669
- Other IDs
- 2020 - MeHI - 01
- Status last verified
- Feb 2022
- First submitted
- 11 Jan 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not planned to share with other researchers.
Publications
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.
PubMed 39475852
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Wearable Health Devices and Health and Wellness Behavior Change Support on Health Outcomes and Healthcare Costs
- ClinicalTrials.gov ID
- NCT04712383
- Acronym / sponsor ID
- H00021669
- Conditions
- Health Behavior
- Keywords
- health behavior, fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 597 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Fitbit LLC, Massachusetts eHealth Initiative
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitbit Care intervention arm | Experimental | Combination Product: Fitbit Care intervention armThe 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 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Employed by UMassMemorial Health Care
- Receive benefits from UMassMemorial Health Care
- Have a smartphone
Key exclusion criteria (3 listed)
- Pregnant
- Unable to consent
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit Care intervention armEntire suite of Fitbit Care. | Combination product | Fitbit Care intervention arm |
Primary outcome
Change in total medical expenditures for calendar year 2020 to 2021
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in Biometric Outcomes
Time frame: 12 months
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.
Changes in self-reported health behaviors and levels of motivation and confidence in making improvements
Time frame: 3 months, 6 months, 9 months, and 12 months
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.
8 secondary outcomes
Proportion of participants achieving target biometric outcomes
Time frame: 12 months
Proportion of participants achieving categorical improvement in biometric outcomes
Time frame: 12 months
Correlations between responses to health behavior survey and total medical expenditure and biometric outcomes
Time frame: 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Time frame: weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Time frame: weekly and totaled over 12 months
Changes in metrics collected by Fitbit devices and Fitbit app
Time frame: weekly and totaled over 12 months
Correlations between metrics collected by Fitbit devices and Fitbit app and total medical expenditure and biometric outcomes
Time frame: 12 months
Correlations between engagement with health coach and total medical expenditure and biometric outcomes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Derived from this study: PubMed 39475852Howard-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.
- Individual participant dataSharing planned: No. IPD is not planned to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Bird, MD principal investigator
UMass Memorial Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit Care intervention arm in people with Health Behavior, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total medical expenditures for calendar year 2020 to 2021 (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712383, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.