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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Alex Antonio Florindo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01852981
First received: October 19, 2010
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention
Physical Activity
Behavioral: Lifestyle counseling
Behavioral: Supervised exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care/Health Family Strategy in Brazil.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change from baseline leisure-time physical activity at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline leisure-time physical activity at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline leisure-time physical activity at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline transport-related physical activity at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline transport-related physical activity at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline transport-related physical activity at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline quality of life at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline quality of life at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline physical fitness at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline physical fitness at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline body composition at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline body composition at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline blood pressure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline blood pressure at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline blood glucose at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline blood glucose at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change from baseline blood lipids at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change from baseline blood lipids at 18 months [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle counseling
Physical activity promotion using methods based on health education.
Behavioral: Lifestyle counseling
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.
Experimental: Supervised exercise
Supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations.
Behavioral: Supervised exercise
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.
No Intervention: Control
Control group.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852981

Locations
Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil, 03828000
School of Arts, Sciences and Humanities, University of Sao Paulo
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Alex A Florindo, Ph.D. University of Sao Paulo
  More Information

Additional Information:
No publications provided

Responsible Party: Alex Antonio Florindo, Ph.D., University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01852981     History of Changes
Obsolete Identifiers: NCT01330836
Other Study ID Numbers: 2009/14119-4
Study First Received: October 19, 2010
Last Updated: May 9, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Physical activity promotion
Intervention
Public Health

ClinicalTrials.gov processed this record on July 22, 2014