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Physical ActivityPACTIVEMNCT01852981

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

A study testing Lifestyle counseling and Supervised exercise in people with Physical Activity, run by University of Sao Paulo at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Activity
What is being tested?
Lifestyle counseling and Supervised exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
157 participants
Where
2 sitesBrazil
Study dates
Feb 2011to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old or more;
  • To be registered in the Brazilian public health system.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • University of Sao Paulo

    São Paulo, São Paulo, 03828000

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

    São Paulo, São Paulo

Other trials in Brazil

About this study

Official title: 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).

Read the 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.

Being tested
Lifestyle counseling, Supervised exercise
Keywords
Physical activity promotion, Intervention, Public Health
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle counselingBehavioural

    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 exerciseBehavioural

    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.

Study groups in NCT01852981
Study groupRoleWhat they receive
Lifestyle counselingExperimentalPhysical activity promotion using methods based on health education.
Receives: Behavioral: Lifestyle counseling
Supervised exerciseExperimentalSupervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations.
Receives: Behavioral: Supervised exercise
ControlNo interventionControl group.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 months

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

    Measured: 18 months

Secondary outcomes (16)

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

    Measured: 6 months

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

    Measured: 12 months

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

    Measured: 6 months

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

    Measured: 18 months

  5. Change from baseline quality of life at 12 months

    Measured: 12 months

  6. Change from baseline quality of life at 18 months

    Measured: 18 months

  7. Change from baseline physical fitness at 12 months

    Measured: 12 months

  8. Change from baseline physical fitness at 18 months

    Measured: 18 months

  9. Change from baseline body composition at 12 months

    Measured: 12 months

  10. Change from baseline body composition at 18 months

    Measured: 18 months

  11. Change from baseline blood pressure at 12 months

    Measured: 12 months

  12. Change from baseline blood pressure at 18 months

    Measured: 18 months

  13. Change from baseline blood glucose at 12 months

    Measured: 12 months

  14. Change from baseline blood glucose at 18 months

    Measured: 18 months

  15. Change from baseline blood lipids at 12 months

    Measured: 12 months

  16. Change from baseline blood lipids at 18 months

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2013 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
157 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01852981
Sponsor's protocol ID
2009/14119-4
Other IDs
2009
Acronym
PACTIVEM
Status last verified
May 2013
First submitted
19 Oct 2010
Last updated
14 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24624930

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle counseling and Supervised exercise in people with Physical Activity, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline leisure-time physical activity at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01852981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.

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