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Completed

NCT Number: NCT01852981

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

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).

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Key information

Conditions

Physical Activity Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Arts, Sciences and Humanities, University of Sao Paulo, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Counseling

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change from baseline leisure-time physical activity at 12 months

    Time frame: 12 months

  2. Change from baseline leisure-time physical activity at 18 months

    Time frame: 18 months

Secondary outcomes

  1. Change from baseline leisure-time physical activity at 6 months

    Time frame: 6 months

  2. Change from baseline transport-related physical activity at 12 months

    Time frame: 12 months

  3. Change from baseline transport-related physical activity at 6 months

    Time frame: 6 months

  4. Change from baseline transport-related physical activity at 18 months

    Time frame: 18 months

  5. Change from baseline quality of life at 12 months

    Time frame: 12 months

  6. Change from baseline quality of life at 18 months

    Time frame: 18 months

  7. Change from baseline physical fitness at 12 months

    Time frame: 12 months

  8. Change from baseline physical fitness at 18 months

    Time frame: 18 months

  9. Change from baseline body composition at 12 months

    Time frame: 12 months

  10. Change from baseline body composition at 18 months

    Time frame: 18 months

  11. Change from baseline blood pressure at 12 months

    Time frame: 12 months

  12. Change from baseline blood pressure at 18 months

    Time frame: 18 months

  13. Change from baseline blood glucose at 12 months

    Time frame: 12 months

  14. Change from baseline blood glucose at 18 months

    Time frame: 18 months

  15. Change from baseline blood lipids at 12 months

    Time frame: 12 months

  16. Change from baseline blood lipids at 18 months

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Acronym: PACTIVEM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 14, 2013
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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