Physical ActivityNCT02554435
TAME Health: Testing Activity Monitors' Effect on Health
A study testing EAM, 5 A's counseling and Pedometer in people with Physical Activity, run by The University of Texas Medical Branch, Galveston at 2 sites in United States.
Trial summary
Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- EAM, 5 A's counseling and Pedometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- physically inactive (less than 60 minutes per week)
- BMI between 25-35
- in good health measured by Par-Q+
- access to a smart phone
Who cannot join
- 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
Show all 9Show fewer
- report alcohol or drug problem
- institutionalized for psychiatric illness within the last year
- do not consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Primary Care Pavilion
Galveston, Texas, 77551
Victory Lakes Town Center
League City, Texas, 77573
About this study
Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.
Read the 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).
- Conditions
- Physical Activity
- Being tested
- EAM, 5 A's counseling, Pedometer
- Keywords
- physical activity, activity monitor, older adults, 5 A's counseling
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAMDevice
Also called UP24, Jawbone, Electronic Activity Monitor
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.
5 A's counselingBehavioural
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.
PedometerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer | Active comparator | 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. Receives: Behavioral: 5 A's counseling; Device: Pedometer |
| Electronic Activity Monitor (EAM) | Experimental | 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. Receives: Device: EAM; Behavioral: 5 A's counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Minutes Measured by a SenseWear Armband
Minutes of moderate-vigorous physical activity over a 7 day period
Measured: Physical activity minutes at the end of the 12 week intervention
Composite Measure for Cardiovascular Risk Measured by the Framingham Non-laboratory Risk Calculator
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.
Measured: Cardiovascular risk at the end of the 12 week intervention
6-minute Walk Test
distance walked in 6 minutes
Measured: Fitness at the end of the 12 week intervention
Steps Per Day
Measured by a SenseWear Armband. Average steps per day over a 7 day period
Measured: Steps per day at the end of the 12 week intervention
Secondary outcomes (10)
Weight
Measured: Weight at the end of the 12 week intervention
Body Mass Index (BMI)
Measured: BMI at the end of the 12 week intervention
Waist-to-Hip Ratio
Waist-to-Hip ratio was calculated by divided the waist circumference (in inches) by the hip circumference (in inches).
Measured: Waist-to-hip ratio at the end of the 12 week intervention
Blood Pressure
Measured: Blood pressure at the end of the 12 week intervention
Exercise Motivation
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.
Measured: Exercise motivation at the end of the 12 week intervention
Quality of Life Measured by the SF-36 Questionnaire
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.
Measured: Quality of life at the end of the 12 week intervention
Physical Function Measured by the Short Physical Performance Battery
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."
Measured: Physical function at the end of the 12 week intervention
Psychological Feelings
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.
Measured: Psychological feelings at the end of the 12 week intervention
Resting Pulse
Measured: Resting pulse at the end of the 12 week intervention
Change From Baseline in Self-regulation
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.
Measured: Change in self-regulation from baseline and 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Zakkoyya Lewis, BS, Principal investigator, The University of Texas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554435
- Sponsor's protocol ID
- 15-0014
- Status last verified
- May 2018
- First submitted
- 24 Aug 2015
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
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.
PubMed 27129602Lewis 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.
PubMed 32961834Lewis 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.
PubMed 28807041
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TAME Health: Testing Activity Monitors' Effect on Health
- ClinicalTrials.gov ID
- NCT02554435
- Acronym / sponsor ID
- 15-0014
- Conditions
- Physical Activity
- Keywords
- physical activity, activity monitor, older adults, 5 A's counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Sep 2015 (estimated)
- Results
- Posted 10 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease accounts for 1 in 3 deaths among US adults and is strongly related to physical activity. Most older adults do not participate in healthy levels of physical activity. Physical activity promotion and counseling from a primary health care provider is important for disease prevention. In addition to counseling, an activity monitor can increase physical activity through self-regulation. Two types of monitors are available: pedometers and electronic activity monitors (EAMs). Research shows that both monitors are motivational devices that can increase physical activity. Pedometers count steps of the wearer. EAMs can monitor steps, monitor burned calories, quality of sleep, and sedentary time. EAMs may also offer more behavioral change techniques and opportunities for self-monitoring. The goal of this study is to compare the effectiveness of EAMs compared to a pedometer on increasing physical activity and decreasing cardiovascular risk within older adult, primary care patients. The study will include sedentary, overweight primary care patients, 55-74 years of age with access to a smart phone or tablet. All participants will receive brief physical activity counseling. Participants will then be randomized to receive a self-monitoring device (Digi-walker CW-700/701 or UP24 by Jawbone) to wear for 3 months. Investigators will evaluate the following outcomes: physical activity, cardiovascular risk (Framingham risk calculator, fitness), psychological feeling toward exercise, physical function, health status, exercise motivation and self-regulation. The investigators hypothesize that EAMs will be more effective than pedometers in improving these outcomes. The results of this pilot test will aid in the translation of effective physical activity intervention components to primary care clinics for cardiovascular disease prevention.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer | Active comparator | Behavioral: 5 A's counseling, Device: PedometerAll 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. |
| Electronic Activity Monitor (EAM) | Experimental | Device: EAM, Behavioral: 5 A's counselingAll 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. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- physically inactive (less than 60 minutes per week)
- BMI between 25-35
- in good health measured by Par-Q+
- access to a smart phone
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| EAMAlso: UP24, Jawbone, Electronic Activity MonitorThe 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. | Device | Electronic Activity Monitor (EAM) |
| 5 A's counselingBrief 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. | Behavioural | Electronic Activity Monitor (EAM), Pedometer |
| PedometerThe 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. | Device | Pedometer |
Primary outcome
Physical Activity Minutes Measured by a SenseWear Armband
Time frame: Physical activity minutes at the end of the 12 week intervention
Minutes of moderate-vigorous physical activity over a 7 day period
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
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.
6-minute Walk Test
Time frame: Fitness at the end of the 12 week intervention
distance walked in 6 minutes
Steps Per Day
Time frame: Steps per day at the end of the 12 week intervention
Measured by a SenseWear Armband. Average steps per day over a 7 day period
10 secondary outcomes
Weight
Time frame: Weight at the end of the 12 week intervention
Body Mass Index (BMI)
Time frame: BMI at the end of the 12 week intervention
Waist-to-Hip Ratio
Time frame: Waist-to-hip ratio at the end of the 12 week intervention
Blood Pressure
Time frame: Blood pressure at the end of the 12 week intervention
Exercise Motivation
Time frame: Exercise motivation at the end of the 12 week intervention
Quality of Life Measured by the SF-36 Questionnaire
Time frame: Quality of life at the end of the 12 week intervention
Physical Function Measured by the Short Physical Performance Battery
Time frame: Physical function at the end of the 12 week intervention
Psychological Feelings
Time frame: Psychological feelings at the end of the 12 week intervention
Resting Pulse
Time frame: Resting pulse at the end of the 12 week intervention
Change From Baseline in Self-regulation
Time frame: Change in self-regulation from baseline and 12-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27129602Lewis 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.
- Derived from this study: PubMed 32961834Lewis 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.
- Derived from this study: PubMed 28807041Lewis 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.
- TAME health protocol citationLink provided by the sponsor.
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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.
Zakkoyya Lewis, BS principal investigator
The University of Texas Medical Branch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAM, 5 A's counseling and Pedometer in people with Physical Activity, run by The University of Texas Medical Branch, Galveston at 2 sites 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 4 inclusion and 9 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 10 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Activity Minutes Measured by a SenseWear Armband (time frame: Physical activity minutes at the end of the 12 week intervention). The study lists 4 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 NCT02554435, which also lists 3 linked publications.
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 20 Jul 2020.