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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Lifestyle counseling
* Behavioral: Supervised exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>Physical activity promotion using methods based on health education. | Behavioral: Lifestyle counseling<br>* 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.<br>|
| Experimental: Supervised exercise<br>Supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations. | Behavioral: Supervised exercise<br>* 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.<br>|
| No Intervention: Control<br>Control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity promotion, Intervention, Public Health