Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions
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|ClinicalTrials.gov Identifier: NCT03253341|
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2017
Last Update Posted : November 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aging Health Behavior||Behavioral: Smart Aging Program Behavioral: Educational Materials||Not Applicable|
The Smart Aging Program is designed to be scalable, implementable, and sustainable in the real world. This program joins patients and their clinicians with community-based fitness centers. The Smart Aging Program looks to use already existing resources to deliver an innovative program to increase physical activity in older adults.
The program begins at the patient-physician level. The program is conducted in community-based fitness centers, the participant's home (home exercise, monitoring) and also sends physical activity data back to the clinician using mobile technology.
The Smart Aging Program consists of a personalized and structured exercise program combined with lifestyle education and mobile-health monitoring. The exercise program includes a 12-week initiation phase, followed by a 40-week maintenance phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prescribing Smart Aging: Integrating Health Systems With Community-Based Lifestyle Interventions|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Smart Aging Program
Participants will be enrolled into the Smart Aging Program.
Behavioral: Smart Aging Program
Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.
Active Comparator: Control Group
Participants will be enrolled into group that receives educational materials that reflect the current standard of care.
Behavioral: Educational Materials
Current standard of care. Includes education materials covering benefits of a healthy lifestyle.
- Change in Cardiorespiratory Fitness [ Time Frame: Change from Baseline to 12 Weeks ]Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
- Change in Cardiorespiratory Fitness [ Time Frame: Change from Baseline to 52 Weeks ]Measured by peak oxygen consumption (VO2 peak) during treadmill testing.
- Changes in Insulin Resistance [ Time Frame: 52 Weeks ]Measured using Homeostasis Model Assessment 2.
- Change in Fat Mass [ Time Frame: 52 Weeks ]Measured using a dual energy x-ray absorptiometry (DEXA) scan.
- Change in Lean Mass [ Time Frame: 52 Weeks ]Measured using a dual energy x-ray absorptiometry (DEXA) scan.
- Change in Cholesterol [ Time Frame: 52 Weeks ]Changes in total cholesterol, LDL, and HDL will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253341
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jeffrey Burns, MD||University of Kansas Medical Center|