StrokeStEPNCT02701998
The Stroke and Exercise Program
A study testing mHealth-Enhance Physical Activity Intervention and Physical Activity Intervention in people with Stroke and Exercise, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study involves a randomized controlled trial to test the feasibility, acceptability, and efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior (SB) in non-physically impaired patients with… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke, Exercise, Sedentary Lifestyle
- What is being tested?
- mHealth-Enhance Physical Activity Intervention and Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Nov 2019
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to hospital with a diagnosis of TIA or ischemic stroke
- Pre-Discharge Modified Rankin Scale (mRS) or 0 or 1 indicating "no symptoms at all" or "no significant disability despite symptoms: able to carry out all usual duties and activities"
- No major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic disease (as determined by attending physician)
- Are able to successfully complete a submaximal graded exercise test at baseline
- Have access to a home or mobile computer (desktop, laptop, tablet, or smart phone)
Who cannot join
- Are participating in any other research study or structured exercise intervention that might interfere with the proposed study
- Report any condition that in the opinion of investigators would reduce the likelihood of adherence to the study protocol, such as terminal illness, planning to relocate, a history of substance abuse or other significant psychiatric problems, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Miriam Hospital Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
Dale S Bond, Ph.D, 401-793-8950, dbond@lifespan.org
Dale S Bond, Ph.D
About this study
Official title: Development and Pilot Testing of a Scalable mHealth Intervention to Promote Physical Activity in TIA and Stroke Survivors
This study involves a randomized controlled trial to test the feasibility, acceptability, and efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack (TIA).
Read the detailed description
Stroke recently declined from the third to the fifth leading cause of death in the United States. However, Stroke remains the leading cause of long-term disability and is among the most expensive chronic diseases, costing the US approximately 34 billion dollars per year. The decrease in stroke-related mortality has led to an increase in stroke survivors, and it is estimated that the overall prevalence will increase by 25% by 2030 to a record 11 million stroke survivors. Importantly, two-thirds of the nearly one million Americans experiencing ischemic stroke or transient ischemic attack (TIA) will regain functional independence. In these patients, engagement in habitual purposeful physical activity (PA) is a powerful means of secondary stroke prevention.
Habitual PA can improve several other important health indicators in stroke survivors, including cardiorespiratory fitness, functional independence, gait stability, overall vascular health, and cognition, while also reducing the risk for falls, cardiometabolic disease, and adverse recurrent events. Consequently, the American Heart Association/American Stroke Association (AHA/ASA) recommends patients who have survived a stroke and regained functional independence both increase PA and reduce sedentary behaviors (SB). However, these recommendations are not always prescribed, and when they are prescribed, patient compliance is often poor. Recent research involving the use of objective PA monitors shows that stroke survivors are significantly less active than controls and maintain a high level of SB one-year after discharge, regardless of functional capacity. This is especially problematic given that patients who engage in low PA and high SB levels after stroke experience cardiovascular deconditioning, worsening PA intolerance, and additional disability, ultimately increasing risk for recurrent events.
Several barriers may account for low PA and high SB levels in stroke survivors. Many avoid engaging in PA due to fear of falling or triggering a recurrent event. However, the risk of inactivity in this regard is far greater than any risks associated with adopting habitual PA. Other barriers may include post-stroke fatigue, depression, lack of interest, or motivation, negative beliefs towards PA, and lack of support for PA behavior change. Despite the obvious need for behavioral interventions to assist stroke survivors in overcoming barriers to adoption and maintenance of habitual PA, there have been relatively few. Most interventions to date have only included intensive and costly supervised exercise components and have not included instruction in standard PA behavior change strategies (e.g., self-monitoring, goal-setting, reinforcement).
The recent advent of commercially available mobile health (mHealth) technologies that automatically monitor and provide feedback on time spent in PA and SB (i.e., fitness/activity trackers) provide a potentially powerful means to enhance the efficacy and reach of interventions targeting stroke survivors. While a recent randomized controlled trial showed that providing a similar fitness/activity tracker in combination with a single in-person goal setting/counseling session and related printed behavior change materials was more effective than a pedometer and printed materials for increasing both daily moderate-to-vigorous PA (MVPA) and steps in older overweight women, the feasibility, acceptability, and efficacy to this approach in post-stroke and TIA patients is unknown.
The proposed project involves a randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of a mHealth-enhanced PA intervention to increase daily bout-related (≥10-minute bouts) and total (≥1-minute bouts) moderate-intensity PA (MPA) and decrease daily SB in 70 non-physically impaired patients with ischemic stroke or TIA. After visiting the Weight Control Diabetes Research Center (WCDRC) and completing a baseline assessment that includes wearing a multi-sensor armband for 7 days to monitor daily MPA and SB, participants will be randomized to 12 weeks of either: mHealth-enhanced PA intervention (Tech-PAI; n=35) or a standard PA intervention (PAI; n=35), which will serve as an active control group. Participants assigned to Tech-PAI will receive 2 face-to-face goal-setting/counseling sessions (one at baseline to set individualized goals using data observed on the baseline armband monitor) for the first 6 weeks of the intervention and the other at the mid-intervention point (i.e. to evaluate progress and refine individualized goals), a fitness/activity tracker and access to the accompanying website to monitor and observe their progress towards set goals, weekly online skills training videos (during weeks 1-6) to help change PA and SB behaviors, and weekly e-mail feedback from research staff on their progress towards goals (during weeks 1-12). Participants assigned to PAI will also receive two face-to-face PA goal-setting counseling sessions, a pedometer, and printed materials to assist with recording and increasing MPA and steps. Participants in both groups will wear the multi-sensor armband monitor again for 7 days both at mid-intervention (end of week 6) and post-intervention (end of week 12). The Tech-PAI and PAI groups will be compared on changes in daily time spent in MPA and SB from baseline at mid- and post-intervention. At these same time points, the groups will be compared on changes in performance-based measures of cardiorespiratory/physical and cognitive function; questionnaire-based assessments of stroke-specific impact and quality of life and PA-related attitudes and beliefs; and blood pressure and inflammation (i.e. C-reactive protein levels collected via blood samples). Finally, the acceptability of the Tech-PAI will be examined as indicated by fitness tracker and related website usage patterns, completion of online skills training sessions, and participant satisfaction ratings.
- Conditions
- Stroke, Exercise, Sedentary Lifestyle, Ischemic Attack, Transient
- Being tested
- mHealth-Enhance Physical Activity Intervention, Physical Activity Intervention
- Keywords
- Ischemic Stroke, Transient Ischemic Attack, Physical Activity, Sedentary Behavior, Lifestyle, Behavior
- Medical subject headings
- Stroke, Motor Activity, Sedentary Behavior, Ischemic Attack, Transient, Ischemic Stroke, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth-Enhance Physical Activity InterventionBehavioural
Also called Tech-PAI
Physical Activity InterventionOther
Also called PAI
| Study group | Role | What they receive |
|---|---|---|
| mHealth-Enhance Physical Activity Intervention | Experimental | Tech-PAI participants will be given 3 goals: 1) to increase their average baseline daily walking exercise by 30 minutes at week 12; 2) to increase their average baseline daily steps by 4,000 at week 12; and 3) to get up and walk for at least 2 minutes after every 60 minutes of sitting. Participants will receive instruction on how to gradually and safely increase their bout-related walking exercise and steps over the 12 week period. In addition to goal setting, Tech-PAI participants will receive a commercially available activity tracker and accompanying that provides real-time monitoring of steps, activity minutes, and issues a text-based prompt after 60 minutes of sitting to get up and move. Also, participants will receive a weekly e-mail feedback message from research staff on goal progress and will be asked to view weekly Internet-based video lessons that will provide behavioral strategies to increase MPA and steps and decrease SB during the first 6 weeks of the intervention period. Receives: Behavioral: mHealth-Enhance Physical Activity Intervention |
| Physical Activity Intervention | Active comparator | PAI participants will be given the same goals as Tech-PAI intervention participants and receive a pedometer and related print materials to assist them in recording and increasing daily steps and bout-related MPA (but no activity tracker, access to video-based skills training lessons, or weekly feedback). Receives: Other: Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires
Feasibility and acceptability will be measured at the end of the 12-week intervention via questionnaires
Measured: End of 12-week intervention
Change in daily bout-related and total moderate physical activity
Physical activity will be objectively assessed via a multi-sensor monitor.
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in daily percentage of waking hours spent in sedentary behavior
Sedentary behavior will be objectively assessed via a multi-sensor monitor.
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary outcomes (6)
Change in performance-based measure of cardiorespiratory functioning
Measured by submaximal graded exercise test
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in performance-based measure of physical functioning
Measured by a physical functioning task
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in performance-based measure of cognitive function
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in stroke-related impact
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in health-related quality of life
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in C-reactive protein
Measured: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701998
- Sponsor's protocol ID
- 2118-15
- Acronym
- StEP
- Status last verified
- Aug 2018
- First submitted
- 23 Feb 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Scalable mHealth Intervention to Promote Physical Activity in TIA and Stroke Survivors
- ClinicalTrials.gov ID
- NCT02701998
- Acronym / sponsor ID
- StEP / 2118-15
- Conditions
- Stroke, Exercise, Sedentary Lifestyle, Ischemic Attack, Transient
- Keywords
- Ischemic Stroke, Transient Ischemic Attack, Physical Activity, Sedentary Behavior, Lifestyle, Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- 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.
This study involves a randomized controlled trial to test the feasibility, acceptability, and efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack (TIA).
Detailed description
Stroke recently declined from the third to the fifth leading cause of death in the United States. However, Stroke remains the leading cause of long-term disability and is among the most expensive chronic diseases, costing the US approximately 34 billion dollars per year. The decrease in stroke-related mortality has led to an increase in stroke survivors, and it is estimated that the overall prevalence will increase by 25% by 2030 to a record 11 million stroke survivors. Importantly, two-thirds of the nearly one million Americans experiencing ischemic stroke or transient ischemic attack (TIA) will regain functional independence. In these patients, engagement in habitual purposeful physical activity (PA) is a powerful means of secondary stroke prevention.
Habitual PA can improve several other important health indicators in stroke survivors, including cardiorespiratory fitness, functional independence, gait stability, overall vascular health, and cognition, while also reducing the risk for falls, cardiometabolic disease, and adverse recurrent events. Consequently, the American Heart Association/American Stroke Association (AHA/ASA) recommends patients who have survived a stroke and regained functional independence both increase PA and reduce sedentary behaviors (SB). However, these recommendations are not always prescribed, and when they are prescribed, patient compliance is often poor. Recent research involving the use of objective PA monitors shows that stroke survivors are significantly less active than controls and maintain a high level of SB one-year after discharge, regardless of functional capacity. This is especially problematic given that patients who engage in low PA and high SB levels after stroke experience cardiovascular deconditioning, worsening PA intolerance, and additional disability, ultimately increasing risk for recurrent events.
Several barriers may account for low PA and high SB levels in stroke survivors. Many avoid engaging in PA due to fear of falling or triggering a recurrent event. However, the risk of inactivity in this regard is far greater than any risks associated with adopting habitual PA. Other barriers may include post-stroke fatigue, depression, lack of interest, or motivation, negative beliefs towards PA, and lack of support for PA behavior change. Despite the obvious need for behavioral interventions to assist stroke survivors in overcoming barriers to adoption and maintenance of habitual PA, there have been relatively few. Most interventions to date have only included intensive and costly supervised exercise components and have not included instruction in standard PA behavior change strategies (e.g., self-monitoring, goal-setting, reinforcement).
The recent advent of commercially available mobile health (mHealth) technologies that automatically monitor and provide feedback on time spent in PA and SB (i.e., fitness/activity trackers) provide a potentially powerful means to enhance the efficacy and reach of interventions targeting stroke survivors. While a recent randomized controlled trial showed that providing a similar fitness/activity tracker in combination with a single in-person goal setting/counseling session and related printed behavior change materials was more effective than a pedometer and printed materials for increasing both daily moderate-to-vigorous PA (MVPA) and steps in older overweight women, the feasibility, acceptability, and efficacy to this approach in post-stroke and TIA patients is unknown.
The proposed project involves a randomized controlled trial to test the feasibility, acceptability, and preliminary efficacy of a mHealth-enhanced PA intervention to increase daily bout-related (≥10-minute bouts) and total (≥1-minute bouts) moderate-intensity PA (MPA) and decrease daily SB in 70 non-physically impaired patients with ischemic stroke or TIA. After visiting the Weight Control Diabetes Research Center (WCDRC) and completing a baseline assessment that includes wearing a multi-sensor armband for 7 days to monitor daily MPA and SB, participants will be randomized to 12 weeks of either: mHealth-enhanced PA intervention (Tech-PAI; n=35) or a standard PA intervention (PAI; n=35), which will serve as an active control group. Participants assigned to Tech-PAI will receive 2 face-to-face goal-setting/counseling sessions (one at baseline to set individualized goals using data observed on the baseline armband monitor) for the first 6 weeks of the intervention and the other at the mid-intervention point (i.e. to evaluate progress and refine individualized goals), a fitness/activity tracker and access to the accompanying website to monitor and observe their progress towards set goals, weekly online skills training videos (during weeks 1-6) to help change PA and SB behaviors, and weekly e-mail feedback from research staff on their progress towards goals (during weeks 1-12). Participants assigned to PAI will also receive two face-to-face PA goal-setting counseling sessions, a pedometer, and printed materials to assist with recording and increasing MPA and steps. Participants in both groups will wear the multi-sensor armband monitor again for 7 days both at mid-intervention (end of week 6) and post-intervention (end of week 12). The Tech-PAI and PAI groups will be compared on changes in daily time spent in MPA and SB from baseline at mid- and post-intervention. At these same time points, the groups will be compared on changes in performance-based measures of cardiorespiratory/physical and cognitive function; questionnaire-based assessments of stroke-specific impact and quality of life and PA-related attitudes and beliefs; and blood pressure and inflammation (i.e. C-reactive protein levels collected via blood samples). Finally, the acceptability of the Tech-PAI will be examined as indicated by fitness tracker and related website usage patterns, completion of online skills training sessions, and participant satisfaction ratings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth-Enhance Physical Activity Intervention | Experimental | Behavioral: mHealth-Enhance Physical Activity InterventionTech-PAI participants will be given 3 goals: 1) to increase their average baseline daily walking exercise by 30 minutes at week 12; 2) to increase their average baseline daily steps by 4,000 at week 12; and 3) to get up and walk for at least 2 minutes after every 60 minutes of sitting. Participants will receive instruction on how to gradually and safely increase their bout-related walking exercise and steps over the 12 week period. In addition to goal setting, Tech-PAI participants will receive a commercially available activity tracker and accompanying that provides real-time monitoring of steps, activity minutes, and issues a text-based prompt after 60 minutes of sitting to get up and move. Also, participants will receive a weekly e-mail feedback message from research staff on goal progress and will be asked to view weekly Internet-based video lessons that will provide behavioral strategies to increase MPA and steps and decrease SB during the first 6 weeks of the intervention period. |
| Physical Activity Intervention | Active comparator | Other: Physical Activity InterventionPAI participants will be given the same goals as Tech-PAI intervention participants and receive a pedometer and related print materials to assist them in recording and increasing daily steps and bout-related MPA (but no activity tracker, access to video-based skills training lessons, or weekly feedback). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admitted to hospital with a diagnosis of TIA or ischemic stroke
- Pre-Discharge Modified Rankin Scale (mRS) or 0 or 1 indicating "no symptoms at all" or "no significant disability despite symptoms: able to carry out all usual duties and activities"
- No major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic disease (as determined by attending physician)
- Are able to successfully complete a submaximal graded exercise test at baseline
- Have access to a home or mobile computer (desktop, laptop, tablet, or smart phone)
Key exclusion criteria (2 listed)
- Are participating in any other research study or structured exercise intervention that might interfere with the proposed study
- Report any condition that in the opinion of investigators would reduce the likelihood of adherence to the study protocol, such as terminal illness, planning to relocate, a history of substance abuse or other significant psychiatric problems, etc.
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 |
|---|---|---|
| mHealth-Enhance Physical Activity InterventionAlso: Tech-PAI | Behavioural | mHealth-Enhance Physical Activity Intervention |
| Physical Activity InterventionAlso: PAI | Other | Physical Activity Intervention |
Primary outcome
Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires
Time frame: End of 12-week intervention
Feasibility and acceptability will be measured at the end of the 12-week intervention via questionnaires
Change in daily bout-related and total moderate physical activity
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Physical activity will be objectively assessed via a multi-sensor monitor.
Change in daily percentage of waking hours spent in sedentary behavior
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Sedentary behavior will be objectively assessed via a multi-sensor monitor.
6 secondary outcomes
Change in performance-based measure of cardiorespiratory functioning
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in performance-based measure of physical functioning
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in performance-based measure of cognitive function
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in stroke-related impact
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in health-related quality of life
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Change in C-reactive protein
Time frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth-Enhance Physical Activity Intervention and Physical Activity Intervention in people with Stroke and Exercise, run by The Miriam Hospital 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dale S Bond, Ph.D (401-793-8950, dbond@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires (time frame: End of 12-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2019.