Physical ActivityEIMNCT03416634
Exercise is Medicine at Emory Seavey Internal Medicine Clinic
A study testing App, Wearable Device and Automated Motivational Message in people with Physical Activity, run by Emory University at 1 site in United States.
Trial summary
Implementation of physical activity promotion in routine health care delivery is low because of multiple barriers including insufficient health system support, care team coordination, and scarcity of community resources for referring patients and technology tools for sustaining lifestyle changes. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- App, Wearable Device and Automated Motivational Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to 1 Feb 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one documented cardiovascular disease risk factor
- Not meeting physical activity (PA) guidelines (aerobic and/or muscle-strengthening standards)
- contemplating PA engagement
- Non-wheelchair bound (other assist devices will be acceptable) or major physical limitations for PA
- Cleared for independent PA by their health care provider
- Willingness to participate and provide written informed consent
- Report access to a mobile phone with data plan and/or computer with internet access
- Agrees to not own/use a different PA wearable device during the study period.
Who cannot join
- Documented unstable angina or myocardial infarction in the past 3 months without having finalized an initial cardiac rehabilitation program;
- Documented end-stage renal disease or life-threatening disease;
- Diagnosed major mental health disorder;
- Alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
United States1 site
Paul W. Seavey Internal Medicine Clinic
Atlanta, Georgia, 30322
About this study
Official title: Exercise is Medicine (EIM): A Quality Improvement and Pragmatic Trial at Emory Seavey Internal Medicine Clinic
Implementation of physical activity promotion in routine health care delivery is low because of multiple barriers including insufficient health system support, care team coordination, and scarcity of community resources for referring patients and technology tools for sustaining lifestyle changes. This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol, including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow. Physically inactive adult patients with at least one documented cardiovascular disease risk factor will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device or a smartphone app to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention.
Read the detailed description
Improving and maintaining health-enhancing levels of physical activity (PA) leads to reductions in the metabolic, hemodynamic, body composition, epi-genetic and functional status risk factors that heavily contribute to the development of many non-communicable chronic diseases. As such, PA has a significant role, in many cases comparable or superior to drug interventions, in the prevention and treatment of more than 40 diseases such as obesity, heart disease, diabetes, hypertension, cancer, depression, anxiety, arthritis, and osteoporosis.
While conceptually simple, implementing clinical-community linkages for PA promotion is hindered by barriers at multiple levels such as inadequate training and self-efficacy among health care providers (HCPs), insufficient health system support and care team coordination, and scarcity of certified community resources for referring patients. The challenge for HCPs and health systems is how to operationalize, standardize, and implement PA promotion in a cost-effective and innovative fashion.
This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow of the Seavey Internal Medicine Clinic at Emory University. Physically inactive adult patients with at least one documented cardiovascular disease risk factor (overweight/obesity, dyslipidemia, hypertension, diabetes) but cleared for self-directed exercise by their treating clinician will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device (Garmin vivofit 3) or a smartphone app (Microsoft Band) to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention. The researchers will assess changes in objectively-measured physical activity (primary outcome) and explore impact on secondary outcomes including cardiovascular disease (CVD) risk factors (assessed routinely as part of clinical management), as well as self-reported mental health, quality of life and exercise self-efficacy using validated questionnaires.
- Conditions
- Physical Activity
- Being tested
- App, Wearable Device, Automated Motivational Message, Personalized Motivational Message
- Keywords
- Health promotion, Behavioral research, Preventive medicine, Obesity, Cardiovascular disease
- Medical subject headings
- Motor Activity, Obesity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppBehavioural
The Microsoft Band app can be installed for free on compatible smartphones. The app can be used to track steps while the phone is with the participant (such as in a pocket). Participants can synchronize their device with the study app to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.
Wearable DeviceBehavioural
A Garmin vivofit 3 fitness device will be provided for free to participants randomized to this study arm. This wearable device tracks daily activity and gives reminders to move after an hour of inactivity. The battery lasts for one year and the device is water resistant. Participants can synchronize their device with the study App to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.
Automated Motivational MessageBehavioural
An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.
Personalized Motivational MessageBehavioural
A behavioral intervention will be delivered once weekly via an in-app motivational message adapted to each patient's personalized PA goal progression based on the previous week data from the smartphone activity app (Microsoft band) or the Garmin wearable device over a 12-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| App Alone | Active comparator | Participants randomized to use the Microsoft Band app to track daily activity Receives: Behavioral: App |
| App Plus Automated Motivational Message | Experimental | Participants randomized to use the Microsoft Band app to track daily activity, and to receive automated, motivational text messages Receives: Behavioral: App; Behavioral: Automated Motivational Message |
| App Plus Personalized Motivational Message | Experimental | Participants randomized to use the Microsoft Band app to track daily activity, and to receive personalized, motivational text messages Receives: Behavioral: App; Behavioral: Personalized Motivational Message |
| Wearable Device Alone | Active comparator | Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity Receives: Behavioral: Wearable Device |
| Wearable Device Plus Automated Motivational Message | Experimental | Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive automated, motivational text messages Receives: Behavioral: Wearable Device; Behavioral: Automated Motivational Message |
| Wearable Device Plus Personalized Motivational Message | Experimental | Participants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive personalized, motivational text messages Receives: Behavioral: Wearable Device; Behavioral: Personalized Motivational Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity
Physical activity will be measured through the Microsoft Band app or with the Garmin vivofit 3. The physical activity of the participants will be monitored during the 12 week intervention period (when some study arms will receive motivational messages) and through 12 additional weeks of follow up.
Measured: Baseline through Week 24
Secondary outcomes (13)
Change in weight
Weight in kilograms will be measured at baseline and throughout the study period.
Measured: Baseline through Week 24
Change in triglycerides
The cardiovascular disease risk factor of dyslipidemia will be assessed by measuring triglycerides at baseline and throughout the study period. Triglycerides above 150 mg/dL are considered high.
Measured: Baseline through Week 24
Change in total cholesterol
The cardiovascular disease risk factor of dyslipidemia will be assessed by measuring total cholesterol at baseline and throughout the study period. Total cholesterol above 200 mg/dL is considered high.
Measured: Baseline through Week 24
Change in hypertension status
The cardiovascular disease risk factor of hypertension will be assessed by measuring blood pressure at baseline and throughout the study period. Blood pressure will be measured as systolic and diastolic millimeters of mercury (mmHg). A blood pressure reading of 140/90 mmHg for a sustained period is considered hypertension.
Measured: Baseline through Week 24
Change in blood glucose
Blood glucose levels will be measured at baseline and throughout the study. Normal fasting blood glucose levels are between 70 and 100 mg/dL.
Measured: Baseline through Week 24
Change in hemoglobin A1c (HbA1c)
HbA1c levels will be measured at baseline and throughout the study. The normal range for HbA1c levels is between 4% and 5.6% of total hemoglobin. Diabetes is diagnosed if HbA1c is greater than 6.5%.
Measured: Baseline through Week 24
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Symptoms of depression will be measured with the Center for Epidemiologic Studies Depression Scale (CES-D), National Institute of Mental Health (NIMH). The CES-D asks respondents to indicate how they have felt or behaved in the past week to 20 symptoms of depression, such as "My sleep was restless" and "I was happy". Participants will select from Rarely (<1 day), Some of the time (1-2 days), Occasionally (3-4 days) and Most of the time (5-7 days). Responses are scored from 0 to 3, with reverse scoring for positive items so that 0 corresponds with low symptoms. Total possible scores range from 0 to 60, with higher scores indicating increased symptoms of depression.
Measured: Baseline, Week 12, Week 24
Change in Eating Habits Confidence Survey Score
Self-efficacy to make dietary changes will be measured with the Eating Habits Confidence Survey. This survey asks participants to rate how confident they are that they could motivate themselves to make certain dietary changes for 6 months. The 20-item survey includes statements such as "Eat smaller portions at dinner" and respondents indicate how sure they can do each item on a 5 point scale where 1 = "I know I cannot" and 5 = "I know I can". Total scores range from 20 to 100, where higher scores indicate increased confidence in making dietary changes.
Measured: Baseline, Week 12, Week 24
Change in Exercise Confidence Survey Score
Self-efficacy to make changes in exercise habits will be measured with the Exercise Confidence Survey. This survey asks participants to rate how confident they are that they could motivate themselves to make certain changes to physical activity habits for 6 months. The 12-item survey includes statements such as "Get up early, even on weekends, to exercise" and respondents indicate how sure they can do each item on a 5 point scale where 1 = "I know I cannot" and 5 = "I know I can". Total scores range from 12 to 60, where higher scores indicate increased confidence in making changes to exercise habits.
Measured: Baseline, Week 12, Week 24
Change in Social Support and Exercise Survey Score
The Social Support and Exercise Survey assesses how much support the respondent receives from family members and friends. Participants will rate how often each of the 13 incidents specified occurred in the last three months, rating family and friends separately. Each item is rated on a scale of 1 to 5 where 1 = none and 5 = very often. The responses will be summed to obtain an overall score of the support received from family and friends. Total scores can range from 26 to 130. Scores for particular items are scored in reverse so that higher scores indicate more support.
Measured: Baseline, Week 12, Week 24
Change in Short-Form Patient Satisfaction Questionnaire (PSQ-18) Score
The Short-Form Patient Satisfaction Questionnaire (PSQ-18) asks respondents how much they agree with statements related to the medical care they receive. The 18-item questionnaire includes statements such as "Doctors are good about explaining the reason for medical tests" and "Doctors sometimes ignore what I tell them". Each item is rated from 1 (strongly agree) to 5 (disagree). All items are scored so that high scores reflect satisfaction with medical care. Total scores can range from 18 to 90.
Measured: Baseline, Week 12, Week 24
Change in 12-Item Short-Form Health Survey (SF-12) Score
The 12-Item Short-Form Health Survey (SF-12) asks respondents to rate their health and abilities to do their usual tasks. The SF-12 uses a variety of questions and response options and includes a physical health component summary and a mental health component summary. Scores are reversed, when appropriate, so that a higher value indicates better health. The scale is transformed to have a mean of 50 and a standard deviation of 10; scores above 50 indicate better health than the general US population, while scores below 50 indicate poorer than average health.
Measured: Baseline, Week 12, Week 24
Change in 36-Item Short-Form Health Survey (SF-36) Score
The 36-Item Short-Form Health Survey (SF-36) asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed and averaged to obtain a mean score for the entire survey.
Measured: Baseline, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start20 Aug 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 90 participants will use a wearable device and 90 will use a smartphone app to track activity. These groups will be further randomized to receive an automated motivational intervention, or a personalized motivational intervention or no additional intervention; each study arm will have 30 participants.
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Horesh Bergquist, Emory University
- Investigators
- Sharon Bergquist, MD, Principal investigator, Emory UniversityRoberto Felipe Lobelo, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416634
- Sponsor's protocol ID
- IRB00101370
- Acronym
- EIM
- Status last verified
- Feb 2020
- First submitted
- 24 Jan 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise is Medicine (EIM): A Quality Improvement and Pragmatic Trial at Emory Seavey Internal Medicine Clinic
- ClinicalTrials.gov ID
- NCT03416634
- Acronym / sponsor ID
- EIM / IRB00101370
- Conditions
- Physical Activity
- Keywords
- Health promotion, Behavioral research, Preventive medicine, Obesity, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
Implementation of physical activity promotion in routine health care delivery is low because of multiple barriers including insufficient health system support, care team coordination, and scarcity of community resources for referring patients and technology tools for sustaining lifestyle changes. This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol, including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow. Physically inactive adult patients with at least one documented cardiovascular disease risk factor will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device or a smartphone app to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention.
Detailed description
Improving and maintaining health-enhancing levels of physical activity (PA) leads to reductions in the metabolic, hemodynamic, body composition, epi-genetic and functional status risk factors that heavily contribute to the development of many non-communicable chronic diseases. As such, PA has a significant role, in many cases comparable or superior to drug interventions, in the prevention and treatment of more than 40 diseases such as obesity, heart disease, diabetes, hypertension, cancer, depression, anxiety, arthritis, and osteoporosis.
While conceptually simple, implementing clinical-community linkages for PA promotion is hindered by barriers at multiple levels such as inadequate training and self-efficacy among health care providers (HCPs), insufficient health system support and care team coordination, and scarcity of certified community resources for referring patients. The challenge for HCPs and health systems is how to operationalize, standardize, and implement PA promotion in a cost-effective and innovative fashion.
This study is a pilot project to test the feasibility of implementing a physical activity promotion protocol including routine evaluation of patient's physical activity levels and provision of educational material in the clinical workflow of the Seavey Internal Medicine Clinic at Emory University. Physically inactive adult patients with at least one documented cardiovascular disease risk factor (overweight/obesity, dyslipidemia, hypertension, diabetes) but cleared for self-directed exercise by their treating clinician will be invited to participate in physical activity intervention. Patients will be randomized to receive a wearable device (Garmin vivofit 3) or a smartphone app (Microsoft Band) to objectively monitor their physical activity. Participants will be further randomized to receive automated motivational text messages, or a personalized motivational message, or no messages. Participants will be followed through the 12 week intervention period and an additional 12 weeks with no intervention. The researchers will assess changes in objectively-measured physical activity (primary outcome) and explore impact on secondary outcomes including cardiovascular disease (CVD) risk factors (assessed routinely as part of clinical management), as well as self-reported mental health, quality of life and exercise self-efficacy using validated questionnaires.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 90 participants will use a wearable device and 90 will use a smartphone app to track activity. These groups will be further randomized to receive an automated motivational intervention, or a personalized motivational intervention or no additional intervention; each study arm will have 30 participants.
| Arm | Type | Receives |
|---|---|---|
| App Alone | Active comparator | Behavioral: AppParticipants randomized to use the Microsoft Band app to track daily activity |
| App Plus Automated Motivational Message | Experimental | Behavioral: App, Behavioral: Automated Motivational MessageParticipants randomized to use the Microsoft Band app to track daily activity, and to receive automated, motivational text messages |
| App Plus Personalized Motivational Message | Experimental | Behavioral: App, Behavioral: Personalized Motivational MessageParticipants randomized to use the Microsoft Band app to track daily activity, and to receive personalized, motivational text messages |
| Wearable Device Alone | Active comparator | Behavioral: Wearable DeviceParticipants randomized to use the Garmin vivofit 3 wearable device to track daily activity |
| Wearable Device Plus Automated Motivational Message | Experimental | Behavioral: Wearable Device, Behavioral: Automated Motivational MessageParticipants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive automated, motivational text messages |
| Wearable Device Plus Personalized Motivational Message | Experimental | Behavioral: Wearable Device, Behavioral: Personalized Motivational MessageParticipants randomized to use the Garmin vivofit 3 wearable device to track daily activity, and to receive personalized, motivational text messages |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least one documented cardiovascular disease risk factor
- Not meeting physical activity (PA) guidelines (aerobic and/or muscle-strengthening standards)
- contemplating PA engagement
- Non-wheelchair bound (other assist devices will be acceptable) or major physical limitations for PA
- Cleared for independent PA by their health care provider
Key exclusion criteria (4 listed)
- Documented unstable angina or myocardial infarction in the past 3 months without having finalized an initial cardiac rehabilitation program;
- Documented end-stage renal disease or life-threatening disease;
- Diagnosed major mental health disorder;
- Alcohol or drug abuse.
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 |
|---|---|---|
| AppThe Microsoft Band app can be installed for free on compatible smartphones. The app can be used to track steps while the phone is with the participant (such as in a pocket). Participants can synchronize their device with the study app to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks. | Behavioural | App Alone, App Plus Automated Motivational Message, App Plus Personalized Motivational Message |
| Wearable DeviceA Garmin vivofit 3 fitness device will be provided for free to participants randomized to this study arm. This wearable device tracks daily activity and gives reminders to move after an hour of inactivity. The battery lasts for one year and the device is water resistant. Participants can synchronize their device with the study App to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks. | Behavioural | Wearable Device Alone, Wearable Device Plus Automated Motivational Message, Wearable Device Plus Personalized Motivational Message |
| Automated Motivational MessageAn automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period. | Behavioural | App Plus Automated Motivational Message, Wearable Device Plus Automated Motivational Message |
| Personalized Motivational MessageA behavioral intervention will be delivered once weekly via an in-app motivational message adapted to each patient's personalized PA goal progression based on the previous week data from the smartphone activity app (Microsoft band) or the Garmin wearable device over a 12-week intervention period. | Behavioural | App Plus Personalized Motivational Message, Wearable Device Plus Personalized Motivational Message |
Primary outcome
Change in Physical Activity
Time frame: Baseline through Week 24
Physical activity will be measured through the Microsoft Band app or with the Garmin vivofit 3. The physical activity of the participants will be monitored during the 12 week intervention period (when some study arms will receive motivational messages) and through 12 additional weeks of follow up.
13 secondary outcomes
Change in weight
Time frame: Baseline through Week 24
Change in triglycerides
Time frame: Baseline through Week 24
Change in total cholesterol
Time frame: Baseline through Week 24
Change in hypertension status
Time frame: Baseline through Week 24
Change in blood glucose
Time frame: Baseline through Week 24
Change in hemoglobin A1c (HbA1c)
Time frame: Baseline through Week 24
Change in Center for Epidemiologic Studies Depression Scale (CES-D) Score
Time frame: Baseline, Week 12, Week 24
Change in Eating Habits Confidence Survey Score
Time frame: Baseline, Week 12, Week 24
Change in Exercise Confidence Survey Score
Time frame: Baseline, Week 12, Week 24
Change in Social Support and Exercise Survey Score
Time frame: Baseline, Week 12, Week 24
Change in Short-Form Patient Satisfaction Questionnaire (PSQ-18) Score
Time frame: Baseline, Week 12, Week 24
Change in 12-Item Short-Form Health Survey (SF-12) Score
Time frame: Baseline, Week 12, Week 24
Change in 36-Item Short-Form Health Survey (SF-36) Score
Time frame: Baseline, Week 12, Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sharon Bergquist, MD principal investigator
Emory University
Roberto Felipe Lobelo, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App, Wearable Device and Automated Motivational Message in people with Physical Activity, run by Emory University 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 8 inclusion and 4 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 19 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Physical Activity (time frame: Baseline through Week 24). 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 19 Feb 2020.