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Study of Interventions for Physical Activity Promotion in Primary Health Settings in Brazil

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01330836
First received: April 1, 2011
Last updated: August 5, 2011
Last verified: March 2011
History of Changes
  Purpose

This study intends to verify the effects of two lifestyle and physical activity interventions on adult and elderly population.


Condition Intervention Phase
Physical Activity
Dyslipidemia
 Behavioral: Physical exercise
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Study of Interventions for Physical Activity Promotion in Primary Health Settings in Brazil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Engagement in physical activity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Check the engagement in physical activity and physical exercise and the maintenance of these activities after the intervention (follow up). The measures are: minutes per week of engagement is physical activity assessed by questionnaire and number of steps assessed by step counter (pedometer).


Secondary Outcome Measures:
  • Changes in lipid profile [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Check the improvement in lipid profile after 18 months of engagement in physical activity.


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical exercise Behavioral: Physical exercise
Engagement in physical exercise for 12 months and maintenance for more 6 months

Detailed Description:

The study will comprise two different interventions performed at primary health care settings in the City of São Paulo, Brazil: 1) Educational lifestyle focal groups; and 2) Supervised physical exercise.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sedentary behaviour

Exclusion Criteria:

  • Diabetes
  • Cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330836

Locations
Brazil
Escola de Artes, Ciencias e Humanidades, USP
São Paulo, SP, Brazil, 03828-000
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Alex A Florindo, Professor University of Sao Paulo
  More Information

No publications provided

Responsible Party: Alex Antonio Florindo, Professor
ClinicalTrials.gov Identifier: NCT01330836     History of Changes
Other Study ID Numbers: U1111-1120-3629
Study First Received: April 1, 2011
Last Updated: August 5, 2011
Health Authority: Brazil: University of São Paulo

Keywords provided by University of Sao Paulo:
Physical activity intervention
Exercise
Adult population
 Elderly
Physical exercise
Sedentary behaviour

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013