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

May 9, 2013 updated by: Alex Antonio Florindo, University of Sao Paulo

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • School of Arts, Sciences and Humanities, University of Sao Paulo
    • SP
      • Sao Paulo, SP, Brazil, 03828000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Control group.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline leisure-time physical activity at 12 months
Time Frame: 12 months
12 months
Change from baseline leisure-time physical activity at 18 months
Time Frame: 18 months
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline leisure-time physical activity at 6 months
Time Frame: 6 months
6 months
Change from baseline transport-related physical activity at 12 months
Time Frame: 12 months
12 months
Change from baseline transport-related physical activity at 6 months
Time Frame: 6 months
6 months
Change from baseline transport-related physical activity at 18 months
Time Frame: 18 months
18 months
Change from baseline quality of life at 12 months
Time Frame: 12 months
12 months
Change from baseline quality of life at 18 months
Time Frame: 18 months
18 months
Change from baseline physical fitness at 12 months
Time Frame: 12 months
12 months
Change from baseline physical fitness at 18 months
Time Frame: 18 months
18 months
Change from baseline body composition at 12 months
Time Frame: 12 months
12 months
Change from baseline body composition at 18 months
Time Frame: 18 months
18 months
Change from baseline blood pressure at 12 months
Time Frame: 12 months
12 months
Change from baseline blood pressure at 18 months
Time Frame: 18 months
18 months
Change from baseline blood glucose at 12 months
Time Frame: 12 months
12 months
Change from baseline blood glucose at 18 months
Time Frame: 18 months
18 months
Change from baseline blood lipids at 12 months
Time Frame: 12 months
12 months
Change from baseline blood lipids at 18 months
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alex A Florindo, Ph.D., University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009/14119-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings