Physical ActivityNCT01857648
Physical Activity Promotion in the Brazilian Primary Health Care Using Community Health Workers Counseling
A study testing Physical activity counseling in people with Physical Activity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of this study is to test a methodology of counseling on physical activity among Community Health Workers working within primary health care in Brazil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical activity counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or more
- To be registered in the Brazilian public health system
Who cannot join
- Health problem or disease that would make the individual incapable of practice physical activity
- Cognitive problem or disease that would not allow the individual from answering the questionnaire alone
- To have plans to move house over the six-months subsequent period
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Arts, Sciences and Humanities, University of Sao Paulo
São Paulo, São Paulo
About this study
The aim of this study is to test a methodology of counseling on physical activity among Community Health Workers working within primary health care in Brazil.
Read the detailed description
This is an intervention study conducted with 176 people attended by two Primary Health Units in the city of São Paulo, Brazil. The intervention group received home visits of Community Health Workers trained on counseling on physical activity promotion. These workers received a course of 12 hours aimed to improve their knowledge and attitude about physical activity promotion. Evaluations will be done at the study baseline and 6 months after the beginning. The primary outcome is the population leisure-time and transport-related physical activity level.
- Conditions
- Physical Activity
- Being tested
- Physical activity counseling
- Keywords
- Physical Activity, Health Promotion, Primary Health Care, Intervention Studies, Public health Practice
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity counselingOther
Home visits including physical activity promotion by the trained Community Health Workers.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity counseling | Experimental | Home visits including physical activity promotion by the trained Community Health Workers. Receives: Other: Physical activity counseling |
| Control | No intervention | Control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline leisure-time and transport-related physical activity at 6 months
Measured in minutes per week
Measured: 6 months
Secondary outcomes (8)
Change from baseline self-rated health at 6 months
Measured: 6 months
Change from baseline stage of behavior change at 6 months
Measured: 6 months
Change from baseline barriers to physical activity practice at 6 months
Measured: 6 months
Change from baseline Community Health Workers's counseling on physical activity at 6 months
Measured: 6 months
Change from baseline Community Health Workers's knowledge about physical activity promotion at 1 month
Measured: 1 month
Change from baseline Community Health Workers's knowledge about physical activity promotion at 5 months
Measured: 5 months
Change from baseline Community Health Workers's attitude about physical activity promotion at 1 month
Measured: 1 month
Change from baseline Community Health Workers's attitude about physical activity promotion at 5 months
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Alex Antonio Florindo, University of Sao Paulo
- Investigators
- Alex A Florindo, Ph.D., Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857648
- Sponsor's protocol ID
- 2009/14119-5
- Other IDs
- 2009
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Florindo AA, Costa EF, Sa TH, dos Santos TI, Velardi M, Andrade DR. Physical activity promotion in primary health care in Brazil: a counseling model applied to community health workers. J Phys Act Health. 2014 Nov;11(8):1531-9. doi: 10.1123/jpah.2012-0260. Epub 2013 Dec 31.
PubMed 24385474
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Promotion in the Brazilian Primary Health Care Using Community Health Workers Counseling
- ClinicalTrials.gov ID
- NCT01857648
- Acronym / sponsor ID
- 2009/14119-5
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Health Promotion, Primary Health Care, Intervention Studies, Public health Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 May 2013 (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.
The aim of this study is to test a methodology of counseling on physical activity among Community Health Workers working within primary health care in Brazil.
Detailed description
This is an intervention study conducted with 176 people attended by two Primary Health Units in the city of São Paulo, Brazil. The intervention group received home visits of Community Health Workers trained on counseling on physical activity promotion. These workers received a course of 12 hours aimed to improve their knowledge and attitude about physical activity promotion. Evaluations will be done at the study baseline and 6 months after the beginning. The primary outcome is the population leisure-time and transport-related physical activity level.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity counseling | Experimental | Other: Physical activity counselingHome visits including physical activity promotion by the trained Community Health Workers. |
| Control | No intervention | –Control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or more
- To be registered in the Brazilian public health system
Key exclusion criteria (4 listed)
- Health problem or disease that would make the individual incapable of practice physical activity
- Cognitive problem or disease that would not allow the individual from answering the questionnaire alone
- To have plans to move house over the six-months subsequent period
- Being 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 activity counselingHome visits including physical activity promotion by the trained Community Health Workers. | Other | Physical activity counseling |
Primary outcome
Change from baseline leisure-time and transport-related physical activity at 6 months
Time frame: 6 months
Measured in minutes per week
8 secondary outcomes
Change from baseline self-rated health at 6 months
Time frame: 6 months
Change from baseline stage of behavior change at 6 months
Time frame: 6 months
Change from baseline barriers to physical activity practice at 6 months
Time frame: 6 months
Change from baseline Community Health Workers's counseling on physical activity at 6 months
Time frame: 6 months
Change from baseline Community Health Workers's knowledge about physical activity promotion at 1 month
Time frame: 1 month
Change from baseline Community Health Workers's knowledge about physical activity promotion at 5 months
Time frame: 5 months
Change from baseline Community Health Workers's attitude about physical activity promotion at 1 month
Time frame: 1 month
Change from baseline Community Health Workers's attitude about physical activity promotion at 5 months
Time frame: 5 months
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 20 May 2013.
- Derived from this study: PubMed 24385474Florindo AA, Costa EF, Sa TH, dos Santos TI, Velardi M, Andrade DR. Physical activity promotion in primary health care in Brazil: a counseling model applied to community health workers. J Phys Act Health. 2014 Nov;11(8):1531-9. doi: 10.1123/jpah.2012-0260. Epub 2013 Dec 31.
- Study website.Link provided by the sponsor.
- Research group website.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex A Florindo, Ph.D. principal investigator
University of Sao Paulo
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 counseling in people with Physical Activity, run by University of Sao Paulo at 1 site in Brazil.
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 2 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 20 May 2013. 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 Brazil. 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 from baseline leisure-time and transport-related physical activity at 6 months (time frame: 6 months). 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 NCT01857648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2013.