Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care in Brazil.

Physical Activity Clinical Trial

— PACTIVEM  

Official title:

Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care/Health Family Strategy in Brazil.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852981
• Other study ID #: 2009/14119-4
• Status: Completed
• Phase: N/A
• First received: October 19, 2010
• Last updated: May 9, 2013
• Start date: February 2011
• Est. completion date: October 2012

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

Description:

The effects of two strategies - lifestyle counseling focused on physical activity, and supervised exercise - adapted to the Brazilian primary health care system and resources will be compared between them and with a control group. Subjects are healthy, physically inactive adults from a low socioeconomic area of Sao Paulo city. Evaluations will be done at the study baseline, 6 months, 12 months, and 18 months (6 months follow-up) after the beginning. The primary outcome is leisure-time physical activity.

Other known NCT identifiers

• NCT01330836

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or more;

• To be registered in the Brazilian public health system.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Lifestyle counseling
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
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.

Locations

Country	Name	City	State
Brazil	School of Arts, Sciences and Humanities, University of Sao Paulo	Sao Paulo
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline leisure-time physical activity at 12 months		12 months	No
Primary	Change from baseline leisure-time physical activity at 18 months		18 months	No
Secondary	Change from baseline leisure-time physical activity at 6 months		6 months	No
Secondary	Change from baseline transport-related physical activity at 12 months		12 months	No
Secondary	Change from baseline transport-related physical activity at 6 months		6 months	No
Secondary	Change from baseline transport-related physical activity at 18 months		18 months	No
Secondary	Change from baseline quality of life at 12 months		12 months	No
Secondary	Change from baseline quality of life at 18 months		18 months	No
Secondary	Change from baseline physical fitness at 12 months		12 months	No
Secondary	Change from baseline physical fitness at 18 months		18 months	No
Secondary	Change from baseline body composition at 12 months		12 months	No
Secondary	Change from baseline body composition at 18 months		18 months	No
Secondary	Change from baseline blood pressure at 12 months		12 months	No
Secondary	Change from baseline blood pressure at 18 months		18 months	No
Secondary	Change from baseline blood glucose at 12 months		12 months	No
Secondary	Change from baseline blood glucose at 18 months		18 months	No
Secondary	Change from baseline blood lipids at 12 months		12 months	No
Secondary	Change from baseline blood lipids at 18 months		18 months	No

External Links

•   Research group website.
•   Study website.