- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01857648
Physical Activity Promotion in the Brazilian Primary Health Care Using Community Health Workers Counseling
May 17, 2013 updated by: Alex Antonio Florindo, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil
- School of Arts, Sciences and Humanities, University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years old or more
- To be registered in the Brazilian public health system
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control group.
|
|
|
Experimental: Physical activity counseling
Home visits including physical activity promotion by the trained Community Health Workers.
|
Home visits including physical activity promotion by the trained Community Health Workers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline leisure-time and transport-related physical activity at 6 months
Time Frame: 6 months
|
Measured in minutes per week
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from baseline self-rated health at 6 months
Time Frame: 6 months
|
6 months
|
|
Change from baseline stage of behavior change at 6 months
Time Frame: 6 months
|
6 months
|
|
Change from baseline barriers to physical activity practice at 6 months
Time Frame: 6 months
|
6 months
|
|
Change from baseline Community Health Workers's counseling on physical activity at 6 months
Time Frame: 6 months
|
6 months
|
|
Change from baseline Community Health Workers's knowledge about physical activity promotion at 1 month
Time Frame: 1 month
|
1 month
|
|
Change from baseline Community Health Workers's knowledge about physical activity promotion at 5 months
Time Frame: 5 months
|
5 months
|
|
Change from baseline Community Health Workers's attitude about physical activity promotion at 1 month
Time Frame: 1 month
|
1 month
|
|
Change from baseline Community Health Workers's attitude about physical activity promotion at 5 months
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alex A Florindo, Ph.D., University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
May 15, 2013
First Submitted That Met QC Criteria
May 17, 2013
First Posted (Estimate)
May 20, 2013
Study Record Updates
Last Update Posted (Estimate)
May 20, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2009/14119-5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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