Clinical trial NCT01852981: Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care in Brazil.
Official title: Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care/Health Family Strategy in Brazil.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: Physical activity promotion
Intervention
Public Health
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-05-14
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline leisure-time physical activity at 12 months
timeFrame: 12 months
measure: Change from baseline leisure-time physical activity at 18 months
timeFrame: 18 months
Secondary outcomes:
measure: Change from baseline leisure-time physical activity at 6 months
timeFrame: 6 months
measure: Change from baseline transport-related physical activity at 12 months
timeFrame: 12 months
measure: Change from baseline transport-related physical activity at 6 months
timeFrame: 6 months
measure: Change from baseline transport-related physical activity at 18 months
timeFrame: 18 months
measure: Change from baseline quality of life at 12 months
timeFrame: 12 months
measure: Change from baseline quality of life at 18 months
timeFrame: 18 months
measure: Change from baseline physical fitness at 12 months
timeFrame: 12 months
measure: Change from baseline physical fitness at 18 months
timeFrame: 18 months
measure: Change from baseline body composition at 12 months
timeFrame: 12 months
measure: Change from baseline body composition at 18 months
timeFrame: 18 months
measure: Change from baseline blood pressure at 12 months
timeFrame: 12 months
measure: Change from baseline blood pressure at 18 months
timeFrame: 18 months
measure: Change from baseline blood glucose at 12 months
timeFrame: 12 months
measure: Change from baseline blood glucose at 18 months
timeFrame: 18 months
measure: Change from baseline blood lipids at 12 months
timeFrame: 12 months
measure: Change from baseline blood lipids at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: School of Arts, Sciences and Humanities, University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Alex A Florindo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.