Feasibility and Acceptability of Incorporating Smartwatches Into an Exercise is Medicine Program in Older Individuals

Obesity Clinical Trial

— EIM+  

Official title:

Feasibility and Acceptability of Incorporating Fitbit Smartwatches Into a Health System Referral Based Exercise is Medicine Program in Older Individuals (EIM+)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06287255
• Other study ID #: 2023H0314
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: Ohio State University
• Contact: Toluwa C Nafiu, B.S.
• Phone: 614-293-2404
• Email: toluwaniose.nafiu[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Age 65+

• No healthcare provider-imposed limitations on physical activity

• English-speaking

Exclusion Criteria:

• 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)

• 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.

Related Conditions & MeSH terms

• Obesity
• Physical Inactivity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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.	12 months
Secondary	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).	12 months
Secondary	Change in weight	The secondary outcome is weight before, during and after program completion	12 months
Secondary	Change in BMI	The secondary outcome is BMI before, during and after program completion	12 months
Secondary	Change in hip circumference	The secondary outcome is hip circumference before, during and after program completion	12 months
Secondary	Change in waist circumference	The secondary outcome is waist circumference before, during and after program completion	12 months
Secondary	Change in blood pressure	The secondary outcome is blood pressure before, during and after program completion	12 months
Secondary	Change in heart rate variability	The secondary outcome is heart rate variability before, during and after program completion	12 months
Secondary	Change in hemoglobin A1c	The secondary outcome is hemoglobin A1c before, during and after program completion	12 months
Secondary	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.	12 months
Secondary	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)	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Change in daily steps total	The secondary outcome is daily steps taken before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	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.	12 months
Secondary	Change in sleep quality	The secondary outcome is sleep quality before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	Change in sleep duration	The secondary outcome is sleep duration before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	Change in estimated energy expenditure	The secondary outcome is estimated energy expenditure before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	Change in heart rate	The secondary outcome is heart rate before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	Change in distance moved	The secondary outcome is distance moved before, during and after program completion as assessed by smartwatch tracking.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months