Physical InactivityEIM+NCT06287255
Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals
A study testing EIM+ in people with Physical Inactivity and Obesity, run by Ohio State University at 1 site in United States.
Trial summary
The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Physical Inactivity, Obesity
- What is being tested?
- EIM+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 14 Apr 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65+
- No healthcare provider-imposed limitations on physical activity
- English-speaking
Who cannot join
- Symptoms suggestive of coronary artery disease (CAD) or congestive heart failure (CHF) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion)
- Myocardial infarction within the last 12 months
- Revascularization within the last 12 months
- Stroke/transient ischemic attack (TIA) within the past 12 months
- Unstable angina
- Congestive heart failure (New York Heart Association (NYHA) Class II, III or IV)
Show all 16Show fewer
- Ventricular arrhythmia
- Clinically significant cardiac valve disease
- Blood pressure >160/100 mmHg
- Uncontrolled seizure disorder
- Major surgery within the past three months
- Severe or frequent hypoglycemia
- Inability to independently manage blood glucose during activity
- Severe autonomic or peripheral neuropathy
- Active foot ulcers
- Unstable retinopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)
The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.
The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.
The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.
- Conditions
- Physical Inactivity, Obesity
- Being tested
- EIM+
- Medical subject headings
- Sedentary Behavior, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIM+Behavioural
The Exercise is Medicine (EIM) program involves a personalized exercise prescription and wellness coaching component. At the first 1:1 session, participants are provided with a Fitbit and onboarded with Fitabase, allowing for documentation of baseline health behaviors. Over the course of the program, the EIM fitness specialist reviews Fitbit data and progress towards goals, sending push notifications for encouragement and reminders. A personal training session is conducted, followed by sixteen group sessions including up to eight participants. The final session includes updating goals, incorporating Fitbits, and providing an updated exercise prescription. Upon program completion, participants will attend monthly webinars and health coaching sessions at 6- and 12-months post-program. The program aims to help individuals overcome barriers and maintain long-term exercise self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Exercise is Medicine Plus | Experimental | Participants receiving the Exercise is Medicine program along with a smartwatch. Receives: Behavioral: EIM+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of EIM+
The co-primary outcome is to determine the feasibility of utilizing smartwatches among Exercise is Medicine participants aged 65+ as assessed by the number of eligible referrals agreeing to participate in the intervention, program attendance, and completion rates.
Measured: 12 months
Acceptability of EIM+
The co-primary outcome is to determine the acceptability of utilizing smartwatches among Exercise is Medicine (EIM) participants aged 65+ as assessed by survey responses on perception of wearable devices integrated in to the EIM program and program attendance and completion rates.
Measured: 12 months
Secondary outcomes (25)
Change in physical activity
The secondary outcome of physical activity levels before, during and after program completion (preliminary efficacy) will be examined both continuously (moderate-vigorous physical activity minutes per week) and categorically (meeting the goal of 150 minutes of moderate-vigorous physical activity per week).
Measured: 12 months
Change in weight
The secondary outcome is weight before, during and after program completion
Measured: 12 months
Change in BMI
The secondary outcome is BMI before, during and after program completion
Measured: 12 months
Change in hip circumference
The secondary outcome is hip circumference before, during and after program completion
Measured: 12 months
Change in waist circumference
The secondary outcome is waist circumference before, during and after program completion
Measured: 12 months
Change in blood pressure
The secondary outcome is blood pressure before, during and after program completion
Measured: 12 months
Change in heart rate variability
The secondary outcome is heart rate variability before, during and after program completion
Measured: 12 months
Change in hemoglobin A1c
The secondary outcome is hemoglobin A1c before, during and after program completion
Measured: 12 months
Change in perceived stress
The secondary outcome is perceived stress before, during and after program completion as assessed by responses to the Perceived Stress Scale assessment.
Measured: 12 months
Change in depressive symptoms
The secondary outcome is depressive symptoms before, during and after program completion as assessed by responses to the Patient Health Questionnaire-9 (PHQ-9)
Measured: 12 months
Change in diet
The secondary outcome is diet before, during and after program completion as assessed by responses to the Mediterranean Eating Pattern for Americans diet adherence screener.
Measured: 12 months
Change in activity minutes per week
The secondary outcome is activity minutes per week before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in daily steps total
The secondary outcome is daily steps taken before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in measured steps per minute
The secondary outcome is measured steps per minute before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in sleep quality
The secondary outcome is sleep quality before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in sleep duration
The secondary outcome is sleep duration before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in estimated energy expenditure
The secondary outcome is estimated energy expenditure before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in heart rate
The secondary outcome is heart rate before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in distance moved
The secondary outcome is distance moved before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in minutes of vigorous activity
The secondary outcome is minutes of vigorous activity before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in minutes of moderate activity
The secondary outcome is minutes of moderate activity before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in minutes of light activity
The secondary outcome is minutes of light activity before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in minutes of sedentary time
The secondary outcome is minutes of sedentary time before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in number of manually entered and automatically detected physical activities (walking, running, etc.)
The secondary outcome is manually entered and automatically detected physical activities (walking, running, etc.) before, during and after program completion as assessed by smartwatch tracking.
Measured: 12 months
Change in quality of life measures
The secondary outcome is quality of life measures before, during and after program completion as assessed by responses to the RAND Short Form (RAND-SF 36) v1.0 survey.
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 posted1 Mar 2024
- Study start15 Mar 2024
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
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 Physical InactivityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-arm trial
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Joseph, MD, Ohio State University
- Investigators
- Joshua Joseph, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287255
- Sponsor's protocol ID
- 2023H0314
- Acronym
- EIM+
- Status last verified
- Nov 2026
- First submitted
- 5 Feb 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hauben J, Luthy J, Nafiu T, Brengartner A, Omar M, Nemati D, Zhao S, Brock G, Urse K, Paro J, Joseph JJ. Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals. Contemp Clin Trials. 2026 Jan;160:108152. doi: 10.1016/j.cct.2025.108152. Epub 2025 Nov 18.
PubMed 41265833
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)
- ClinicalTrials.gov ID
- NCT06287255
- Acronym / sponsor ID
- EIM+ / 2023H0314
- Conditions
- Physical Inactivity, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 1 Mar 2024 (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 effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life.
The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease.
The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-arm trial
| Arm | Type | Receives |
|---|---|---|
| Exercise is Medicine Plus | Experimental | Behavioral: EIM+Participants receiving the Exercise is Medicine program along with a smartwatch. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65+
- No healthcare provider-imposed limitations on physical activity
- English-speaking
Key exclusion criteria (16 listed)
- Symptoms suggestive of coronary artery disease (CAD) or congestive heart failure (CHF) (i.e. chest pain, dizziness, syncope, excessive dyspnea on exertion)
- Myocardial infarction within the last 12 months
- Revascularization within the last 12 months
- Stroke/transient ischemic attack (TIA) within the past 12 months
- Unstable angina
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 |
|---|---|---|
| EIM+The Exercise is Medicine (EIM) program involves a personalized exercise prescription and wellness coaching component. At the first 1:1 session, participants are provided with a Fitbit and onboarded with Fitabase, allowing for documentation of baseline health behaviors. Over the course of the program, the EIM fitness specialist reviews Fitbit data and progress towards goals, sending push notifications for encouragement and reminders. A personal training session is conducted, followed by sixteen group sessions including up to eight participants. The final session includes updating goals, incorporating Fitbits, and providing an updated exercise prescription. Upon program completion, participants will attend monthly webinars and health coaching sessions at 6- and 12-months post-program. The program aims to help individuals overcome barriers and maintain long-term exercise self-efficacy. | Behavioural | Exercise is Medicine Plus |
Primary outcome
Feasibility of EIM+
Time frame: 12 months
The co-primary outcome is to determine the feasibility of utilizing smartwatches among Exercise is Medicine participants aged 65+ as assessed by the number of eligible referrals agreeing to participate in the intervention, program attendance, and completion rates.
Acceptability of EIM+
Time frame: 12 months
The co-primary outcome is to determine the acceptability of utilizing smartwatches among Exercise is Medicine (EIM) participants aged 65+ as assessed by survey responses on perception of wearable devices integrated in to the EIM program and program attendance and completion rates.
25 secondary outcomes
Change in physical activity
Time frame: 12 months
Change in weight
Time frame: 12 months
Change in BMI
Time frame: 12 months
Change in hip circumference
Time frame: 12 months
Change in waist circumference
Time frame: 12 months
Change in blood pressure
Time frame: 12 months
Change in heart rate variability
Time frame: 12 months
Change in hemoglobin A1c
Time frame: 12 months
Change in perceived stress
Time frame: 12 months
Change in depressive symptoms
Time frame: 12 months
Change in diet
Time frame: 12 months
Change in activity minutes per week
Time frame: 12 months
Change in daily steps total
Time frame: 12 months
Change in measured steps per minute
Time frame: 12 months
Change in sleep quality
Time frame: 12 months
Change in sleep duration
Time frame: 12 months
Change in estimated energy expenditure
Time frame: 12 months
Change in heart rate
Time frame: 12 months
Change in distance moved
Time frame: 12 months
Change in minutes of vigorous activity
Time frame: 12 months
Change in minutes of moderate activity
Time frame: 12 months
Change in minutes of light activity
Time frame: 12 months
Change in minutes of sedentary time
Time frame: 12 months
Change in number of manually entered and automatically detected physical activities (walking, running, etc.)
Time frame: 12 months
Change in quality of life measures
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 5 Nov 2026.
- Derived from this study: PubMed 41265833Hauben J, Luthy J, Nafiu T, Brengartner A, Omar M, Nemati D, Zhao S, Brock G, Urse K, Paro J, Joseph JJ. Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals. Contemp Clin Trials. 2026 Jan;160:108152. doi: 10.1016/j.cct.2025.108152. Epub 2025 Nov 18.
- Individual participant dataSharing planned: No
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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.
Joshua Joseph, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIM+ in people with Physical Inactivity and Obesity, run by Ohio State University 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 16 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 5 Nov 2026. 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?
Feasibility of EIM+ (time frame: 12 months). The study lists 2 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 NCT06287255, 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 5 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.