Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care in Brazil.
PACTIVEM
1 other identifier
interventional
157
1 country
2
Brief Summary
To verify changes in physical activity levels, metabolic markers, and physical fitness as results of two physical activity interventions within the Brazilian public health system (primary health care).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedMay 14, 2013
May 1, 2013
1 year
October 19, 2010
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline leisure-time physical activity at 12 months
12 months
Change from baseline leisure-time physical activity at 18 months
18 months
Secondary Outcomes (16)
Change from baseline leisure-time physical activity at 6 months
6 months
Change from baseline transport-related physical activity at 12 months
12 months
Change from baseline transport-related physical activity at 6 months
6 months
Change from baseline transport-related physical activity at 18 months
18 months
Change from baseline quality of life at 12 months
12 months
- +11 more secondary outcomes
Study Arms (3)
Lifestyle counseling
EXPERIMENTALPhysical activity promotion using methods based on health education.
Supervised exercise
EXPERIMENTALSupervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations.
Control
NO INTERVENTIONControl group.
Interventions
Strategies consisted of group discussion, some physical activities, phone support, and printed materials. The content and strategies were elaborated by a team formed by a doctor, nutritionists, a psychologist, and physical education professionals and the main aim was to promote the engagement in physical activity, working not only on behavioral change but also on the environment attributes available for physical activity practice. The main strategy was the group discussion, which sessions lasted 120 minutes each and its frequency changed as follow: in the first month they were weekly; in the second occurred twice per month; and in the third month onwards sessions were monthly. All sessions occurred in the Primary Health Unit or inside a community association building.
Supervised exercise program in groups. Individuals in this program participated in three weekly structured and supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations. Load, intensity, and exercise adjustments were made during the program. All sessions lasted 60 minutes each and occurred in a gymnasium nearby the Primary Health Unit.
Eligibility Criteria
You may qualify if:
- years old or more;
- To be registered in the Brazilian public health system.
You may not qualify if:
- Practice of leisure-time physical activity in the previous month;
- Practice of transport-related physical activity (walking or cycling) for at least 150 minutes in the previous week;
- Diagnostic of type II diabetes or severe arterial hypertension;
- Use of beta-blockers for treating hypertension or cardiovascular disease;
- Health problem or disease that would make the individual incapable of leaving home and making the journey to practice physical activity;
- Diseases such as cancer, cirrhosis, chronic kidney disease, chronic obstructive pulmonary disease osteoporosis and severe depression at advanced stages;
- Cognitive problem or disease that would not allow the individual from answering the questionnaire alone;
- Being morbidly obese, with a body mass index (BMI) ≥40 kg/m2;
- To have plans to move house over the two-year subsequent period;
- Being pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Sao Paulo
São Paulo, São Paulo, 03828000, Brazil
School of Arts, Sciences and Humanities, University of Sao Paulo
São Paulo, São Paulo, Brazil
Related Publications (1)
Salvador EP, Ribeiro EH, Garcia LM, Andrade DR, Guimaraes VM, Aoki MS, Florindo AA. Interventions for physical activity promotion applied to the primary healthcare settings for people living in regions of low socioeconomic level: study protocol for a non-randomized controlled trial. Arch Public Health. 2014 Mar 13;72(1):8. doi: 10.1186/2049-3258-72-8.
PMID: 24624930DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alex A Florindo, Ph.D.
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
October 19, 2010
First Posted
May 14, 2013
Study Start
February 1, 2011
Primary Completion
February 1, 2012
Study Completion
October 1, 2012
Last Updated
May 14, 2013
Record last verified: 2013-05