Chronic DiseaseNCT01776632
Promoting Physical Activity in Churchgoing Latinas
A study testing Physical activity and Cancer screening in people with Chronic Disease, run by San Diego State University at 1 site in United States.
Trial summary
The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Physical activity and Cancer screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2011to 21 Dec 2015
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65 years of age
- Latino
- Must be a member of a participating church for at least six months
- Live within 10-15 minutes driving distance from the church
- Able to travel to the church during the week
- Able to attend activities at the church during the week
Show all 9Show fewer
- Attend church activities (worship or otherwise) at least 4 times a month
- Plan on living in same residence for the next 24 months
- Engage in less than 150 minutes of moderate-to-vigorous physical activity per week
Who cannot join
- Attendance at other churches participating in the study
- Must not have any conditions limiting ability to be physically active
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University Research Foundation
San Diego, California, 92123
About this study
Official title: Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.
The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.
Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.
Read the detailed description
This two-group randomized controlled trial combines innovative and traditional methods for promoting moderate-to-vigorous physical activity (MVPA) and cancer screening (breast, cervical, colorectal, and skin) among Latinas, and is tested simultaneously in a two-group design. Both interventions lasted two years. The study's primary outcome was min/week of accelerometer-assessed MVPA at baseline (M1) and 12 months (M2) and 24 months (M3) following the start of the intervention.We selected cancer screening as a comparison condition given the relevance of this topic to our target community (i.e., low cervical and colorectal cancer screening rates and follow-up). It was hypothesized that over time, participants in the physical activity condition would engage in significantly higher levels of MVPA, compared to participants in the cancer screening condition. We also expected greater changes in individual-, interpersonal-, and environmental-level correlates of physical activity among participants in the physical activity condition compared to those in the cancer screening condition. Conversely, we expected that participants in the cancer screening condition would engage in higher screening rates compared to those in the physical activity intervention.We anticipated greater changes in individual, interpersonal, and environmental correlates of cancer screening in this condition compared to the physical activity condition.
- Conditions
- Chronic Disease
- Being tested
- Physical activity, Cancer screening
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Also called Faith in Action, Fe en Acción
Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.
Cancer screeningBehavioural
Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Latinas exposed to multi-level Faith in Action intervention promoting physical activity. Receives: Behavioral: Physical activity |
| Cancer screening | Active comparator | Latinas exposed to Faith in Action intervention on cancer screening and prevention. Receives: Behavioral: Cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
Measured: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Self-report Leisure-time MVPA
Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity
Measured: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Secondary outcomes (2)
Body Mass Index (BMI)
Change from baseline in body mass index (BMI)
Measured: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Waist Circumference
Change from baseline in waist circumference
Measured: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start11 May 2011
- Primary completion21 Dec 2015
- Study completion21 Dec 2015
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 (13)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by San Diego State 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elva Arredondo, San Diego State University
- Investigators
- Elva M Arredondo, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776632
- Sponsor's protocol ID
- R01CA138894
- Other IDs
- R01CA138894-05S1, R01CA138894-05S2
- Status last verified
- Sep 2021
- First submitted
- 29 Oct 2012
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Arredondo EM, Haughton J, Ayala GX, Slymen DJ, Sallis JF, Burke K, Holub C, Chanson D, Perez LG, Valdivia R, Ryan S, Elder J. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas. Contemp Clin Trials. 2015 Nov;45(Pt B):404-415. doi: 10.1016/j.cct.2015.09.008. Epub 2015 Sep 8.
PubMed 26358535Haughton J, Ayala GX, Burke KH, Elder JP, Montanez J, Arredondo EM. Community Health Workers Promoting Physical Activity: Targeting Multiple Levels of the Social Ecological Model. J Ambul Care Manage. 2015 Oct-Dec;38(4):309-20. doi: 10.1097/JAC.0000000000000108.
PubMed 26280587Beard M, Chuang E, Haughton J, Arredondo EM. Determinants of Implementation Effectiveness in a Physical Activity Program for Church-Going Latinas. Fam Community Health. 2016 Oct-Dec;39(4):225-33. doi: 10.1097/FCH.0000000000000122.
PubMed 27536927Perez LG, Slymen DJ, Sallis JF, Ayala GX, Elder JP, Arredondo EM. Interactions between individual and perceived environmental factors on Latinas' physical activity. J Public Health (Oxf). 2017 Jun 1;39(2):e10-e18. doi: 10.1093/pubmed/fdw061.
PubMed 27412175Perez LG, Chavez A, Marquez DX, Soto SC, Haughton J, Arredondo EM. Associations of Acculturation With Self-Report and Objective Physical Activity and Sedentary Behaviors Among Latinas. Health Educ Behav. 2017 Jun;44(3):431-438. doi: 10.1177/1090198116669802. Epub 2016 Sep 27.
PubMed 27679665Perez LG, Carlson J, Slymen DJ, Patrick K, Kerr J, Godbole S, Elder JP, Ayala GX, Arredondo EM. Does the social environment moderate associations of the built environment with Latinas' objectively-measured neighborhood outdoor physical activity? Prev Med Rep. 2016 Oct 19;4:551-557. doi: 10.1016/j.pmedr.2016.10.006. eCollection 2016 Dec.
PubMed 27818913Tristao Parra M, Porfirio GJM, Arredondo EM, Atallah AN. Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Am J Health Promot. 2018 Mar;32(3):677-690. doi: 10.1177/0890117116688107. Epub 2017 Jan 13.
PubMed 29214856Elder JP, Haughton J, Perez LG, Martinez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Accion/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033.
PubMed 28380627Soto SH, Arredondo EM, Haughton J, Shakya H. Leisure-Time Physical Activity and Characteristics of Social Network Support for Exercise Among Latinas. Am J Health Promot. 2018 Feb;32(2):432-439. doi: 10.1177/0890117117699927. Epub 2017 Mar 31.
PubMed 28359166Perez LG, Elder JP, Haughton J, Martinez ME, Arredondo EM. Socio-demographic Moderators of Associations Between Psychological Factors and Latinas' Breast Cancer Screening Behaviors. J Immigr Minor Health. 2018 Aug;20(4):823-830. doi: 10.1007/s10903-017-0633-1.
PubMed 28752364Perez LG, Kerr J, Sallis JF, Slymen D, McKenzie TL, Elder JP, Arredondo EM. Perceived Neighborhood Environmental Factors That Maximize the Effectiveness of a Multilevel Intervention Promoting Physical Activity Among Latinas. Am J Health Promot. 2018 Feb;32(2):334-343. doi: 10.1177/0890117117742999. Epub 2017 Nov 22.
PubMed 29166779Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Accion: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.303785. Epub 2017 May 18.
PubMed 28520484Arredondo EM, Haughton J, Ayala GX, Slymen D, Sallis JF, Perez LG, Serrano N, Ryan S, Valdivia R, Lopez NV, Elder JP. Two-year outcomes of Faith in Action/Fe en Accion: a randomized controlled trial of physical activity promotion in Latinas. Int J Behav Nutr Phys Act. 2022 Jul 30;19(1):97. doi: 10.1186/s12966-022-01329-6.
PubMed 35907867
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity in Churchgoing Latinas: Fe en Acción (Faith in Action)
- ClinicalTrials.gov ID
- NCT01776632
- Acronym / sponsor ID
- R01CA138894
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 May 2011 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 21 Dec 2015 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The low prevalence of moderate-to-vigorous physical activity (MVPA) among adult Latinas likely contributes to the high rates of cancer and other chronic diseases in this population. The goals of the current study, based largely upon the core principles of the Social Ecological Model, are to design, implement, and evaluate an innovative multi-level intervention promoting physical activity among churchgoing Latinas.
The evidenced-based intervention targets three "tiers" of environmental influences (i.e., church, immediate neighborhood surrounding the church, and community) on activity, as well as MVPA-related personal factors (i.e.., interpersonal, cultural, and perceived environmental variables). The physical activity intervention will be compared with an attention-control condition providing health education on cancer screening and prevention.
Sixteen churches will be randomly assigned to either the physical activity intervention or the attention-control condition. The primary aim of the study is to determine whether a multi-level intervention will increase MVPA among Latina churchgoers in the intervention condition relative to the attention-control condition.
Detailed description
This two-group randomized controlled trial combines innovative and traditional methods for promoting moderate-to-vigorous physical activity (MVPA) and cancer screening (breast, cervical, colorectal, and skin) among Latinas, and is tested simultaneously in a two-group design. Both interventions lasted two years. The study's primary outcome was min/week of accelerometer-assessed MVPA at baseline (M1) and 12 months (M2) and 24 months (M3) following the start of the intervention.We selected cancer screening as a comparison condition given the relevance of this topic to our target community (i.e., low cervical and colorectal cancer screening rates and follow-up). It was hypothesized that over time, participants in the physical activity condition would engage in significantly higher levels of MVPA, compared to participants in the cancer screening condition. We also expected greater changes in individual-, interpersonal-, and environmental-level correlates of physical activity among participants in the physical activity condition compared to those in the cancer screening condition. Conversely, we expected that participants in the cancer screening condition would engage in higher screening rates compared to those in the physical activity intervention.We anticipated greater changes in individual, interpersonal, and environmental correlates of cancer screening in this condition compared to the physical activity condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityLatinas exposed to multi-level Faith in Action intervention promoting physical activity. |
| Cancer screening | Active comparator | Behavioral: Cancer screeningLatinas exposed to Faith in Action intervention on cancer screening and prevention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Between the ages of 18-65 years of age
- Latino
- Must be a member of a participating church for at least six months
- Live within 10-15 minutes driving distance from the church
- Able to travel to the church during the week
Key exclusion criteria (3 listed)
- Attendance at other churches participating in the study
- Must not have any conditions limiting ability to be physically active
- Pregnant
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 |
|---|---|---|
| Physical activityAlso: Faith in Action, Fe en AcciónPromotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors. | Behavioural | Physical activity |
| Cancer screeningPromotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals. | Behavioural | Cancer screening |
Primary outcome
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA)
Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in moderate-to-vigorous physical activity as assessed by accelerometer
Self-report Leisure-time MVPA
Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Change from baseline in self-reported leisure-time moderate-to-vigorous physical activity
2 secondary outcomes
Body Mass Index (BMI)
Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Waist Circumference
Time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26358535Arredondo EM, Haughton J, Ayala GX, Slymen DJ, Sallis JF, Burke K, Holub C, Chanson D, Perez LG, Valdivia R, Ryan S, Elder J. Fe en Accion/Faith in Action: Design and implementation of a church-based randomized trial to promote physical activity and cancer screening among churchgoing Latinas. Contemp Clin Trials. 2015 Nov;45(Pt B):404-415. doi: 10.1016/j.cct.2015.09.008. Epub 2015 Sep 8.
- Background: PubMed 26280587Haughton J, Ayala GX, Burke KH, Elder JP, Montanez J, Arredondo EM. Community Health Workers Promoting Physical Activity: Targeting Multiple Levels of the Social Ecological Model. J Ambul Care Manage. 2015 Oct-Dec;38(4):309-20. doi: 10.1097/JAC.0000000000000108.
- Background: PubMed 27536927Beard M, Chuang E, Haughton J, Arredondo EM. Determinants of Implementation Effectiveness in a Physical Activity Program for Church-Going Latinas. Fam Community Health. 2016 Oct-Dec;39(4):225-33. doi: 10.1097/FCH.0000000000000122.
- Background: PubMed 27412175Perez LG, Slymen DJ, Sallis JF, Ayala GX, Elder JP, Arredondo EM. Interactions between individual and perceived environmental factors on Latinas' physical activity. J Public Health (Oxf). 2017 Jun 1;39(2):e10-e18. doi: 10.1093/pubmed/fdw061.
- Background: PubMed 27679665Perez LG, Chavez A, Marquez DX, Soto SC, Haughton J, Arredondo EM. Associations of Acculturation With Self-Report and Objective Physical Activity and Sedentary Behaviors Among Latinas. Health Educ Behav. 2017 Jun;44(3):431-438. doi: 10.1177/1090198116669802. Epub 2016 Sep 27.
- Background: PubMed 27818913Perez LG, Carlson J, Slymen DJ, Patrick K, Kerr J, Godbole S, Elder JP, Ayala GX, Arredondo EM. Does the social environment moderate associations of the built environment with Latinas' objectively-measured neighborhood outdoor physical activity? Prev Med Rep. 2016 Oct 19;4:551-557. doi: 10.1016/j.pmedr.2016.10.006. eCollection 2016 Dec.
- Background: PubMed 29214856Tristao Parra M, Porfirio GJM, Arredondo EM, Atallah AN. Physical Activity Interventions in Faith-Based Organizations: A Systematic Review. Am J Health Promot. 2018 Mar;32(3):677-690. doi: 10.1177/0890117116688107. Epub 2017 Jan 13.
- Background: PubMed 28380627Elder JP, Haughton J, Perez LG, Martinez ME, De la Torre CL, Slymen DJ, Arredondo EM. Promoting cancer screening among churchgoing Latinas: Fe en Accion/faith in action. Health Educ Res. 2017 Apr 1;32(2):163-173. doi: 10.1093/her/cyx033.
- Background: PubMed 28359166Soto SH, Arredondo EM, Haughton J, Shakya H. Leisure-Time Physical Activity and Characteristics of Social Network Support for Exercise Among Latinas. Am J Health Promot. 2018 Feb;32(2):432-439. doi: 10.1177/0890117117699927. Epub 2017 Mar 31.
- Background: PubMed 28752364Perez LG, Elder JP, Haughton J, Martinez ME, Arredondo EM. Socio-demographic Moderators of Associations Between Psychological Factors and Latinas' Breast Cancer Screening Behaviors. J Immigr Minor Health. 2018 Aug;20(4):823-830. doi: 10.1007/s10903-017-0633-1.
- Background: PubMed 29166779Perez LG, Kerr J, Sallis JF, Slymen D, McKenzie TL, Elder JP, Arredondo EM. Perceived Neighborhood Environmental Factors That Maximize the Effectiveness of a Multilevel Intervention Promoting Physical Activity Among Latinas. Am J Health Promot. 2018 Feb;32(2):334-343. doi: 10.1177/0890117117742999. Epub 2017 Nov 22.
- Results publication: PubMed 28520484Arredondo EM, Elder JP, Haughton J, Slymen DJ, Sallis JF, Perez LG, Serrano N, Parra MT, Valdivia R, Ayala GX. Fe en Accion: Promoting Physical Activity Among Churchgoing Latinas. Am J Public Health. 2017 Jul;107(7):1109-1115. doi: 10.2105/AJPH.2017.303785. Epub 2017 May 18.
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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.
Elva M Arredondo, PhD principal investigator
San Diego State 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 Physical activity and Cancer screening in people with Chronic Disease, run by San Diego State 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 9 inclusion and 3 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 29 Sep 2021. 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 16 Apr 2019). 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?
Accelerometer-based Moderate-to-vigorous Physical Activity (MVPA) (time frame: assessed at Baseline, 12 and 24 months following implementation of intervention activities, month 12 reported). The study lists 2 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 NCT01776632, which also lists 13 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 29 Sep 2021.