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

University of Sao Paulo

Status: Completed

Conditions: Physical Activity

Treatments: Behavioral: Lifestyle counseling; Behavioral: Supervised exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01852981

2009/14119-4

Details and patient eligibility

About

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).

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 3 patient groups

Lifestyle counseling

Experimental group

Description:

Physical activity promotion using methods based on health education.

Treatment:

Behavioral: Lifestyle counseling

Supervised exercise

Experimental group

Description:

Supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations.

Treatment:

Behavioral: Supervised exercise

Control

No Intervention group

Description:

Control group.