- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554435
TAME Health: Testing Activity Monitors' Effect on Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cardiovascular disease (CVD) is prevalent and the leading cause for mortality in the United States. The American Heart Association's (AHA) 2020 Impact Goal is to improve the cardiovascular health of all Americans by 20 percent while reducing deaths from CVD and stroke by 20 percent. Maintaining healthy levels of physical activity (PA) is critical in maintaining cardiovascular health, but older adults are inactive. Inactivity may be influenced by low levels of motivation. Standard behavioral counseling techniques typically implemented within the primary care setting target increased motivation, but lack the key component of self-control. The addition of electronic activity monitors (EAMs) that provide interactive self-monitoring, feedback, and social support may further increase motivation for exercise by providing more effective behavior change techniques than standard protocols. Investigators will conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (N = 40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer. Investigators propose two Specific Aims:
AIM 1: Evaluate the feasibility and acceptability of implementing a technology-enhanced brief intervention to increase physical activity in a primary care setting. Measures of feasibility will include days the EAM was worn, usage of the app, technological problems, attrition, and adverse events. Acceptability will be measured by self-report and focus groups.
AIM 2: Compare the counseling plus EAM intervention to a counseling plus pedometer intervention. Primary outcomes will be changes in PA and cardiovascular risk. We will also investigate secondary outcomes (differences in adherence, weight and body composition, health status, motivation, physical function, psychological feelings, self-regulation).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77551
- Primary Care Pavilion
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League City, Texas, United States, 77573
- Victory Lakes Town Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- physically inactive (less than 60 minutes per week)
- BMI between 25-35
- in good health measured by Par-Q+
- access to a smart phone
Exclusion Criteria:
- physical activity is inadvisable by their doctor
- involved in another physical activity intervention within the past 6 months
- used an activity monitor in the past 6 months
- unwilling to travel for scheduled visits
- currently taking medications that affect body composition
- current smoker
- report alcohol or drug problem
- institutionalized for psychiatric illness within the last year
- do not consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Pedometer
All participants will be given 5 A's counseling and a digital pedometer (Digi-walker CW-700/701, YAMAX, San Antonio, TX).
Participants will be asked to log their daily steps measured by the pedometer in an activity diary.
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Brief counseling to encourage behavioral change.
The counseling is intended to be administered by a health care provider.
The component of the counseling are assess, advise, agree, assist, and arrange.
The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned.
Participants can review the feedback for the past 7 days.
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Experimental: Electronic Activity Monitor (EAM)
All participants will be given an EAM (UP24 by Jawbone, San Francisco, CA) and the corresponding UP24 application (app) on their smart device.
In addition to monitoring activity, the app allows for social comparison and social interaction.
Participants will "friend" other participants to utilize these features.
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Brief counseling to encourage behavioral change.
The counseling is intended to be administered by a health care provider.
The component of the counseling are assess, advise, agree, assist, and arrange.
The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app).
Participants can review all of their feedback while in the intervention.
If the participants chose, they are also able to monitor their sleep and dietary intake.
The app also provides health tips and daily challenges.
The participants will also have the opportunity to interact with other participants through the social features of the app.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Minutes Measured by a SenseWear Armband
Time Frame: Physical activity minutes at the end of the 12 week intervention
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Minutes of moderate-vigorous physical activity over a 7 day period
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Physical activity minutes at the end of the 12 week intervention
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Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
Time Frame: Cardiovascular risk at the end of the 12 week intervention
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Factors within the risk calculator include of age in years, systolic blood pressure, gender, and body mass index.
These factors are used to create a composite score to estimate the individual's risk for a cardiac event within the next 10 years.
The risk score is not bound by maximums and minimums, however a lower number is more favorable.
Among women, a composite risk score of 10 equates to a 6% risk of a cardiovascular event, a risk score of 15 equates to a 13% risk, a risk score of 20 equates to a 28.5% risk, and a risk score of 21 or higher equates to >30% risk of a cardiovascular event within the next 10 years.
Among men, a composite risk score of 10 equates to a 9% risk, a risk score of 15 equates to a 21.5% risk, and a risk score of 18 or higher equates to >30% risk of a cardiovascular event within the next 10 years.
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Cardiovascular risk at the end of the 12 week intervention
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6-minute Walk Test
Time Frame: Fitness at the end of the 12 week intervention
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distance walked in 6 minutes
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Fitness at the end of the 12 week intervention
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Steps Per Day
Time Frame: Steps per day at the end of the 12 week intervention
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Measured by a SenseWear Armband.
Average steps per day over a 7 day period
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Steps per day at the end of the 12 week intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Weight at the end of the 12 week intervention
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Weight at the end of the 12 week intervention
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Body Mass Index (BMI)
Time Frame: BMI at the end of the 12 week intervention
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BMI at the end of the 12 week intervention
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Waist-to-Hip Ratio
Time Frame: Waist-to-hip ratio at the end of the 12 week intervention
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Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).
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Waist-to-hip ratio at the end of the 12 week intervention
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Blood Pressure
Time Frame: Blood pressure at the end of the 12 week intervention
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Blood pressure at the end of the 12 week intervention
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Exercise Motivation
Time Frame: Exercise motivation at the end of the 12 week intervention
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Measured by Behavioral Regulation in Exercise Questionnaire-2.
Sub-scales include intrinsic, identified, introjected, extrinsic, and amotivation.
Each subscale ranges from 0 - 4, with 0 being lowest and 4 being highest level of motivation for the given subscale.
The different subscales measure varying forms of autonomous motivation; therefore high scores (maximum of 4) of "intrinsic" and "identified" are better.
Alternatively, low scores of "introjected", "extrinsic", and "amotivation" are better.
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Exercise motivation at the end of the 12 week intervention
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Quality of Life Measured by the SF-36 Questionnaire
Time Frame: Quality of life at the end of the 12 week intervention
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Sub-scales include physical functioning, social functioning, physical role limitations, emotional role limitations, mental health, energy/vitality, and pain.
All sub-scales have a range of 0 to 100.
High scores and scores closer to 100 represent a better outcome for each sub-scale.
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Quality of life at the end of the 12 week intervention
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Physical Function Measured by the Short Physical Performance Battery
Time Frame: Physical function at the end of the 12 week intervention
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Physical function is operationalized by 3 functional tests, including repeated chair stands (5 consecutive stands), balance (semi-tandem stand, side-by-side stand, tandem stand) and 8 feet walk.
The time it took for participants to complete each test was timed in seconds.
The faster the repeated chair stand and 8 feet walk tests were performed, the better the function of the individual.
Therefore, lower scores represent a better outcome.
These tests were not bound by maximums.
The higher score for tandem balance, maximum of 10, represents a better outcome.
The balance test is comprised of three positions but time is only recorded for one.
Participants start with the semi-tandem, then if they are able to hold the position for 10 seconds they continue to tandem balance test.
If they are not able to hold the semi-tandem position for 10 seconds, they then complete the side by side test.
In this study, all participants proceeded to the tandem test, so outcome is labeled "tandem balance."
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Physical function at the end of the 12 week intervention
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Psychological Feelings
Time Frame: Psychological feelings at the end of the 12 week intervention
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Measured by the Psychological Need Satisfaction in Exercise Scale.
Sub-scales include perceived competence, perceived autonomy, and perceived relatedness.
Each sub-scale had a range from 1 to 5. Higher scores, in each sub-scale, represent a more favorable outcome.
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Psychological feelings at the end of the 12 week intervention
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Resting Pulse
Time Frame: Resting pulse at the end of the 12 week intervention
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Resting pulse at the end of the 12 week intervention
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Change From Baseline in Self-regulation
Time Frame: Change in self-regulation from baseline and 12-weeks
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Measured by the Rovinak et al scale.
Sub-scales include exercise goals and exercise plans.
The possible scores on both subscales range between 10 and 50, with higher scores representing more favorable outcomes in exercise goals and planning.
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Change in self-regulation from baseline and 12-weeks
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Zakkoyya Lewis, BS, The University of Texas Medical Branch
Publications and helpful links
General Publications
- Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Lyons EJ. Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients. JMIR Res Protoc. 2016 Apr 29;5(2):e59. doi: 10.2196/resprot.5454.
- Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. Effect of Electronic Activity Monitors and Pedometers on Health: Results from the TAME Health Pilot Randomized Pragmatic Trial. Int J Environ Res Public Health. 2020 Sep 18;17(18):6800. doi: 10.3390/ijerph17186800.
- Lewis ZH, Ottenbacher KJ, Fisher SR, Jennings K, Brown AF, Swartz MC, Martinez E, Lyons EJ. The feasibility and RE-AIM evaluation of the TAME health pilot study. Int J Behav Nutr Phys Act. 2017 Aug 14;14(1):106. doi: 10.1186/s12966-017-0560-5.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 15-0014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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