Physical Activity and Sedentary BehaviorNCT03439852
Modifying Physical Activity and Sedentary Time in Filipino Faith Leaders
A study testing Light-to-Moderate Physical Activity / Sedentary Time in people with Physical Activity and Sedentary Behavior and Healthy Aging, run by University of Hawaii at 1 site in United States.
Trial summary
The outcomes of this application will provide nursing researchers with information about ways to increase physical activity (PA) and decrease sedentary time (ST) in at-risk older Filipinos adults who are lay leaders in Filipino Catholic clubs in Hawaii. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity and Sedentary Behavior, Healthy Aging
- What is being tested?
- Light-to-Moderate Physical Activity / Sedentary Time
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2018to 31 May 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Member in one of 10 Filipino Catholic Clubs (within the Oahu Council of Filipino Catholic Clubs) on the island of Oahu in the state of Hawaii
Who cannot join
- Age: less than 55 years OR older than 75 years of age
- Planning to move (off the island of Oahu) in the next 9 months
- Body Mass Index: If BMI is < 18.5 or > 40 (we will be measuring their height and weight to determine BMI at enrollment)
- Currently exercising: Regularly (weekly) active at a moderate intensity* or higher >60 minutes a week (* = brisk walk)
- Currently in Treatment: Actively having cancer treatment or in physical therapy following surgery/stroke
- A recent (in last 6 months) diagnosis of: Cancer, Heart disease, had a heart attack, Lung disease, Chronic Kidney Disease, Stroke, or underwent surgery
Show all 18Show fewer
- Physician recommends that person have only supervised physical activity (i.e., in a health care / physical therapy setting)
- Needs a cane or walker (or other assistive device) to walk especially outdoors on uneven surfaces
- Need health care provider's approval/clearance before enrollment if potential participant has the following:
- Asthma or other respiratory disease made worse by exercise
- A heart valve problem or is taking medications for a heart condition
- Severe osteoarthritis
- Insulin dependent Type 1 or Type 2 diabetes (or often has a blood glucose > 235 mg/dl or 13mmol/L) (need MD clearance if do not know blood glucose)
- Diagnosis/Treatment for Cancer over last 12 months or had a Stroke in the past (> 6 months ago)
- Resting blood pressure ≥ 160/90 (with or without medications) (need MD clearance if do not know BP)
- Has chest pain when exercising or recently (last 4 weeks) developed any chest pain (i.e., when not doing physical activity)
- Has tendency to lose consciousness or collapse from dizziness
- Has a bone or joint problem that could be aggravated by physical activity
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Hawaii at Manoa, Office of Research Services
Honolulu, Hawaii, 96822
About this study
Official title: Increasing Physical Activity in Filipino Lay Leaders
The outcomes of this application will provide nursing researchers with information about ways to increase physical activity (PA) and decrease sedentary time (ST) in at-risk older Filipinos adults who are lay leaders in Filipino Catholic clubs in Hawaii. The proposed 12-week PA/ST program will include both a group-based component (3 group discussions during monthly club meetings) and a personalized telephone counseling component (12 weekly calls from nursing students to problem solve barriers to increasing light-to-moderate physical activity and decreasing / breaking up sedentary time). The project will stimulate multidisciplinary research at our School of Nursing and School of Medicine and has the potential to help older at-risk Filipinos reach national guidelines for healthy levels of physical activity and lower the amount of time they spend sitting/being sedentary.
Read the detailed description
Asian-Americans (A-As) are under-represented in chronic disease research, including lifestyle interventions. A-As are 42% of population in Hawaii and across the U.S. they are projected to more than double to 34.4 million by 2060, with a much higher proportion of older A-As compared to other races. Within A-As, Filipino-Americans have high rates of hypertension, diabetes, and chronic kidney disease, especially as they age. This is largely due to unhealthy diets, high BMIs, sedentary behaviors, and low physical activity (PA). Our previous work found Filipino seniors are under-active and spend > 8 hours a day in sedentary time (ST). About 90% of Filipinos in Hawaii are Catholic and previous PA interventions involving faith-based organizations have been shown to be culturally relevant for ethnic minorities and can effectively increase PA. Our innovative application focuses on changing both PA and ST in 250 Filipino lay leaders who represent their parish within the Oahu Council of Filipino Catholic Clubs (OCFCCs). OCFCCs maintain Filipinos' Catholic traditions and their cultural heritage. This project builds on our previous research with Filipino leaders from these clubs, and our expertise with effective PA and ST interventions. Team includes 3 nursing faculty, 1 medical school faculty, a project director, and from 9-12 graduate /undergraduate nursing students. The students will participate in a community-engaged 3-yr research project relevant both to their future research efforts and their use of self-management strategies with patients who at-risk for chronic diseases. The investigators will develop, implement, and test the efficacy of a culturally tailored PA/ST intervention for under-active/sedentary Filipino seniors (ages: 55-75 yrs) some of who may have multiple morbidities under medical control. The investigators will initially strengthen our partnership with OCFCC by engaging council members in semi-structured meetings where key cultural and familial issues that hinder/facilitate PA/ST will be discussed, the project's name/logo will be created, and plans to facilitate clubs' engagement across 3-year project will be solidified. Specific Aims: 1) test the efficacy of a Light-to-Moderate PA-LMPA/ST intervention with ten OCFCC clubs (25 lay leaders/club; n = 250 total) that will be randomly assigned to either a 12wk LMPA/ST intervention consisting of 3 group discussions during club meetings plus 12 counseling calls, or to Delayed Treatment condition initially given health education materials and 12 contact-matched calls on topics unrelated to PA/ST; then, the LMPA/ST intervention. 2) test maintenance of LMPA/ST 12 wks after LMPA/ST intervention ends. 3) analyze LMPA/ST self-report \& accelerometer data collected at baseline, 12, 24, and 36 wks, and test demographic, psychosocial, environmental, and group factors as mediators/moderators of change in LMPA/ST. 4) discuss project findings with statewide Diocesan Congress of Filipino Catholic Clubs and the feasibility of using lay leaders to change the LMPA/ST of their parishioners from churches across Hawaii via a train-the-trainer lay leader model. This project will stimulate community engaged/team science research at our School of Nursing and enhance students' research skills.
- Being tested
- Light-to-Moderate Physical Activity / Sedentary Time
- Keywords
- physical activity, Sedentary time
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light-to-Moderate Physical Activity / Sedentary TimeBehavioural
Also called LMPA/ST
12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day
| Study group | Role | What they receive |
|---|---|---|
| Light to Moderate Physical Activity/Sedentary behavior | Experimental | The telephone counseling plus group cohesion intervention is designed to increase Light-to-Moderate intensity physical activity (LMPA) and reduce Sedentary time (ST). The 12-wk intervention includes group discussions during 3 regular monthly club meetings when clubs' accumulated milestones for LMPA/ST min/wk will be identified and future cumulative club goals for PA/ST set. In addition, each member will receive 12 weekly personalized phone calls from health coaches who will use motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change. Receives: Behavioral: Light-to-Moderate Physical Activity / Sedentary Time |
| Delayed Treatment/Healthy Aging | No intervention | Delayed Treatment (DT) / Healthy Aging materials Condition is for 12 weeks and participants receive 12 phone calls using a previously developed contact-matched protocol that uses mailed healthy aging information and telephone calls to assess symptom ratings. After the initial 12 weeks they then receive the LMPA/ST intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes Per Week of Hi/Light Intensity Physical Activity
The Community Health Activities Model Program for Seniors (CHAMPS) survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with >2 and <3 Metabolic Equivalents (METs).
Measured: Measured at Baseline and after 12 weeks
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity
The CHAMPS survey was used to assess this outcome. Minutes per week of moderate-to-vigorous intensity physical activity were defined as the sum of all the minutes of physical activities with >3 METs. For both conditions this was from baseline to at 12 weeks
Measured: Measured at Baseline and after 12 weeks
Minutes Per Week Hi/Light Intensity Physical Activity
The CHAMPS survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with >2 and <3 METs. For LMPA/ST condition, their post-intervention was at 12 weeks and their maintenance was at 24 weeks. For DT/HA condition, their post-intervention was at 24 weeks and their maintenance was at 36 weeks.
Measured: 12 weeks after LMPA intervention ended
Secondary outcomes (4)
Hours Per Week of Sedentary Time
Sedentary behavior was measured via the Measure of Older Adults' Sedentary Time (MOST), a validated survey with good test-retest reliability and results from ST interventions have found it sensitive to change. The survey asked respondents to report the time they spent doing 7 different tasks/activities (over last week) while sitting or lying (other than sleeping/napping/ill in bed) including: (1) TV or video/DVD watching, (2) other screen use/internet use: computer/tablet/Smartphone, (3) reading, (4) socializing with friends or family (in-person or when talking on phone), (5) driving/riding in car or city bus, (6) doing hobbies, and (7) any other activities. The total time spent sitting for each task/activity and total across all tasks was calculated.
Measured: Baseline and after 12 weeks
Breaks in Sitting Time Per Hour at Home
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work and at home. This could include standing, stretching, or taking a short walk. Participants were asked to not count breaks to prepare meals at home
Measured: baseline and after 12 weeks
Breaks Per Hour in Sitting Time at Work
The Workplace Sitting Breaks Questionnaire (SITBRQ) asked respondents to consider the past 7 days, and report how many breaks from sitting were taken in an hour at work. This could include standing, stretching, or taking a short walk. Participants were asked to not count lunch breaks/coffee breaks at work
Measured: baseline and after 12 weeks
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week
Outcome was a binary variable reporting whether a participant met 150 min per week of MVPA at each of the two time points (1=met the recommendation, 0=did not meet).
Measured: baseline and after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start11 Mar 2018
- Primary completion22 Jan 2020
- Study completion31 May 2021
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.
- Other trials for Physical Activity and Sedentary BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial comparing physical activity/sedentary time intervention to delayed treatment condition
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clementina Ceria-Ulep, PhD, Principal investigator, University of HawaiiCheryl L Albright, PhD, Principal investigator, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439852
- Sponsor's protocol ID
- R15MD011474
- Status last verified
- May 2023
- First submitted
- 7 Feb 2018
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data will be available for Univ. of Hawaii graduate students/post-doctoral fellows who have been involved in the project for dissertations or publications, first, then to others. Individuals wishing to use our data will be required to fill out a Data Sharing Request Form, which asks for information on the type of data set being requested, anticipated data use, research questions, study design, variables, analysis plan, and human subjects approval. We will also plan for general release and sharing of deidentified data (following the acceptance for publication of the main findings from the study) as we believe this to be essential for expedited translation of research results into larger arenas to improve human health.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Physical Activity in Filipino Lay Leaders
- ClinicalTrials.gov ID
- NCT03439852
- Acronym / sponsor ID
- R15MD011474
- Keywords
- physical activity, Sedentary time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The outcomes of this application will provide nursing researchers with information about ways to increase physical activity (PA) and decrease sedentary time (ST) in at-risk older Filipinos adults who are lay leaders in Filipino Catholic clubs in Hawaii. The proposed 12-week PA/ST program will include both a group-based component (3 group discussions during monthly club meetings) and a personalized telephone counseling component (12 weekly calls from nursing students to problem solve barriers to increasing light-to-moderate physical activity and decreasing / breaking up sedentary time). The project will stimulate multidisciplinary research at our School of Nursing and School of Medicine and has the potential to help older at-risk Filipinos reach national guidelines for healthy levels of physical activity and lower the amount of time they spend sitting/being sedentary.
Detailed description
Asian-Americans (A-As) are under-represented in chronic disease research, including lifestyle interventions. A-As are 42% of population in Hawaii and across the U.S. they are projected to more than double to 34.4 million by 2060, with a much higher proportion of older A-As compared to other races. Within A-As, Filipino-Americans have high rates of hypertension, diabetes, and chronic kidney disease, especially as they age. This is largely due to unhealthy diets, high BMIs, sedentary behaviors, and low physical activity (PA). Our previous work found Filipino seniors are under-active and spend > 8 hours a day in sedentary time (ST). About 90% of Filipinos in Hawaii are Catholic and previous PA interventions involving faith-based organizations have been shown to be culturally relevant for ethnic minorities and can effectively increase PA. Our innovative application focuses on changing both PA and ST in 250 Filipino lay leaders who represent their parish within the Oahu Council of Filipino Catholic Clubs (OCFCCs). OCFCCs maintain Filipinos' Catholic traditions and their cultural heritage. This project builds on our previous research with Filipino leaders from these clubs, and our expertise with effective PA and ST interventions. Team includes 3 nursing faculty, 1 medical school faculty, a project director, and from 9-12 graduate /undergraduate nursing students. The students will participate in a community-engaged 3-yr research project relevant both to their future research efforts and their use of self-management strategies with patients who at-risk for chronic diseases. The investigators will develop, implement, and test the efficacy of a culturally tailored PA/ST intervention for under-active/sedentary Filipino seniors (ages: 55-75 yrs) some of who may have multiple morbidities under medical control. The investigators will initially strengthen our partnership with OCFCC by engaging council members in semi-structured meetings where key cultural and familial issues that hinder/facilitate PA/ST will be discussed, the project's name/logo will be created, and plans to facilitate clubs' engagement across 3-year project will be solidified. Specific Aims: 1) test the efficacy of a Light-to-Moderate PA-LMPA/ST intervention with ten OCFCC clubs (25 lay leaders/club; n = 250 total) that will be randomly assigned to either a 12wk LMPA/ST intervention consisting of 3 group discussions during club meetings plus 12 counseling calls, or to Delayed Treatment condition initially given health education materials and 12 contact-matched calls on topics unrelated to PA/ST; then, the LMPA/ST intervention. 2) test maintenance of LMPA/ST 12 wks after LMPA/ST intervention ends. 3) analyze LMPA/ST self-report \& accelerometer data collected at baseline, 12, 24, and 36 wks, and test demographic, psychosocial, environmental, and group factors as mediators/moderators of change in LMPA/ST. 4) discuss project findings with statewide Diocesan Congress of Filipino Catholic Clubs and the feasibility of using lay leaders to change the LMPA/ST of their parishioners from churches across Hawaii via a train-the-trainer lay leader model. This project will stimulate community engaged/team science research at our School of Nursing and enhance students' research skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial comparing physical activity/sedentary time intervention to delayed treatment condition
| Arm | Type | Receives |
|---|---|---|
| Light to Moderate Physical Activity/Sedentary behavior | Experimental | Behavioral: Light-to-Moderate Physical Activity / Sedentary TimeThe telephone counseling plus group cohesion intervention is designed to increase Light-to-Moderate intensity physical activity (LMPA) and reduce Sedentary time (ST). The 12-wk intervention includes group discussions during 3 regular monthly club meetings when clubs' accumulated milestones for LMPA/ST min/wk will be identified and future cumulative club goals for PA/ST set. In addition, each member will receive 12 weekly personalized phone calls from health coaches who will use motivational interviewing to set individualized LMPA/ST goals setting, reduce barriers, and facilitate social support for LMPA/ST change. |
| Delayed Treatment/Healthy Aging | No intervention | –Delayed Treatment (DT) / Healthy Aging materials Condition is for 12 weeks and participants receive 12 phone calls using a previously developed contact-matched protocol that uses mailed healthy aging information and telephone calls to assess symptom ratings. After the initial 12 weeks they then receive the LMPA/ST intervention |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member in one of 10 Filipino Catholic Clubs (within the Oahu Council of Filipino Catholic Clubs) on the island of Oahu in the state of Hawaii
Key exclusion criteria (18 listed)
- Age: less than 55 years OR older than 75 years of age
- Planning to move (off the island of Oahu) in the next 9 months
- Body Mass Index: If BMI is < 18.5 or > 40 (we will be measuring their height and weight to determine BMI at enrollment)
- Currently exercising: Regularly (weekly) active at a moderate intensity* or higher >60 minutes a week (* = brisk walk)
- Currently in Treatment: Actively having cancer treatment or in physical therapy following surgery/stroke
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 |
|---|---|---|
| Light-to-Moderate Physical Activity / Sedentary TimeAlso: LMPA/ST12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day | Behavioural | Light to Moderate Physical Activity/Sedentary behavior |
Primary outcome
Minutes Per Week of Hi/Light Intensity Physical Activity
Time frame: Measured at Baseline and after 12 weeks
The Community Health Activities Model Program for Seniors (CHAMPS) survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with >2 and <3 Metabolic Equivalents (METs).
Minutes Per Week of Moderate-to-vigorous Intensity Physical Activity
Time frame: Measured at Baseline and after 12 weeks
The CHAMPS survey was used to assess this outcome. Minutes per week of moderate-to-vigorous intensity physical activity were defined as the sum of all the minutes of physical activities with >3 METs. For both conditions this was from baseline to at 12 weeks
Minutes Per Week Hi/Light Intensity Physical Activity
Time frame: 12 weeks after LMPA intervention ended
The CHAMPS survey was used to assess this outcome. Participants reported the number of times/week they do a specific physical activity, and then choose one of 6 time frames that represent the amount of time they did that activity, from less than one hr/week to 9 or more hours/week. Minutes per week of high-light intensity were defined as the sum of all the minutes of physical activities with >2 and <3 METs. For LMPA/ST condition, their post-intervention was at 12 weeks and their maintenance was at 24 weeks. For DT/HA condition, their post-intervention was at 24 weeks and their maintenance was at 36 weeks.
4 secondary outcomes
Hours Per Week of Sedentary Time
Time frame: Baseline and after 12 weeks
Breaks in Sitting Time Per Hour at Home
Time frame: baseline and after 12 weeks
Breaks Per Hour in Sitting Time at Work
Time frame: baseline and after 12 weeks
Percent That Met 150 Minutes of Moderate-to-vigorous Physical Activity (MVPA) Per Week
Time frame: baseline and after 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Deidentified data will be available for Univ. of Hawaii graduate students/post-doctoral fellows who have been involved in the project for dissertations or publications, first, then to others. Individuals wishing to use our data will be required to fill out a Data Sharing Request Form, which asks for information on the type of data set being requested, anticipated data use, research questions, study design, variables, analysis plan, and human subjects approval. We will also plan for general release and sharing of deidentified data (following the acceptance for publication of the main findings from the study) as we believe this to be essential for expedited translation of research results into larger arenas to improve human health.
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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.
Clementina Ceria-Ulep, PhD principal investigator
University of Hawaii
Cheryl L Albright, PhD principal investigator
University of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light-to-Moderate Physical Activity / Sedentary Time in people with Physical Activity and Sedentary Behavior and Healthy Aging, run by University of Hawaii 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 1 inclusion and 18 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 18 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2023). 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?
Minutes Per Week of Hi/Light Intensity Physical Activity (time frame: Measured at Baseline and after 12 weeks). 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 18 Jun 2023.