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

Not Applicable

Completed

• Conditions: Physical Activity
• Interventions: Behavioral: Lifestyle counseling; Behavioral: Supervised exercise

• Registration Number: NCT01852981
• Lead Sponsor: University of Sao Paulo

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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-10-19
• Study Start: 2011-02
• Primary Completion: 2012-02
• Study Completion: 2012-10
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Study First Posted: 2013-05-14
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

• 18 years old or more;
• To be registered in the Brazilian public health system.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle counseling	Physical activity promotion using methods based on health education.
Supervised exercise	Supervised exercise	Supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change from baseline quality of life at 18 months	18 months
Change from baseline physical fitness at 12 months	12 months
Change from baseline physical fitness at 18 months	18 months
Change from baseline body composition at 12 months	12 months
Change from baseline body composition at 18 months	18 months
Change from baseline blood pressure at 12 months	12 months
Change from baseline blood pressure at 18 months	18 months
Change from baseline blood glucose at 12 months	12 months
Change from baseline blood glucose at 18 months	18 months
Change from baseline blood lipids at 12 months	12 months
Change from baseline blood lipids at 18 months	18 months

Trial Locations

Locations (2)

School of Arts, Sciences and Humanities, University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil

University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil