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

NCT ID: NCT01852981

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-10-31

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.

Conditions

Physical Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Physical activity promotion using methods based on health education.

Group Type: EXPERIMENTAL

Lifestyle counseling

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Supervised exercise

Intervention Type: 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.

Control

Control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Alex Antonio Florindo

Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alex A Florindo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

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

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 24624930 (View on PubMed)

Related Links

http://www.each.usp.br/gepaf

Research group website.

Other Identifiers

2009/14119-4

Identifier Type: -

Identifier Source: org_study_id

NCT01330836

Identifier Type: -

Identifier Source: nct_alias