- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02857127
Physical Activity Promotion in Primary Health Care Settings
Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings
Study Overview
Detailed Description
There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering programs of physical activity becomes a convenient option to increase the physical activity level of the population and promote aging process more active and healthy over the life. There is need for greater depth in relation to the operation of programs to promote physical activity and the effects of these programs on different biopsychosocial aspects, especially those offered in primary care settings. This research aims to evaluate a walking program geared to adults and seniors on the following aspects:
- Characteristics and operation of the intervention,
- effects of behavior change to physical activity, and
- biopsychosocial effects of physical activity.
It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and control group (n = 71). The intervention will last for six months, with a subsequent follow-up period of six months after the intervention. The program will offer supervised exercise twice a week, lasting an hour. The classes will consist of recreational activities, walking and educational strategies of behavior change for physical activity. Variables will be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over 40 years, low levels of education, income and varied biopsychosocial characteristics are expected. After the intervention, it is expected that the program present characteristics of low adhesion and retention, especially because of the barrier "lack of time". Still, the promotion of supervised walking increase levels of physical activity beyond the time provided by the program and it will improve the biopsychosocial conditions of the participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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São Carlos, São Paulo, Brazil, 13565-517
- Secretaria Municipal de Saúde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- To be insufficiently active
- To accept the intervention invitation
- Living around the selected primary health care
- To sign the Term os Consent
- To have 18 years or more
Exclusion Criteria:
- To participate only in one day of intervention
- To have less than 75% of presence in the intervention
- To give up of the intervention
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
A group of people who participated in the walking program during a six month period.
This group also received an educational material and attended meetings for behavioral change strategies.
|
To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.
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No Intervention: Control Group
A group of people who did not receive the educational material and did not participated in any of the activities offered by the research team, such as walking classes and meetings for behavioral change.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire
Time Frame: six months
|
Physical activity level evaluated through the International Physical Activity Questionnaire
|
six months
|
Objective evaluation of physical activity level evaluated through accelerometer device
Time Frame: six months
|
Physical activity level evaluated through accelerometer device
|
six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Grace AO Gomes, Doctor, Universidade Federal de Sao Carlos
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FAPESP14/03909-2
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.
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