Motor ActivityNCT02857127
Physical Activity Promotion in Primary Health Care Settings
A study testing Walking program in people with Motor Activity, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Jul 2016
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- To participate only in one day of intervention
- To have less than 75% of presence in the intervention
- To give up of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings
A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area
Read the 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.
- Conditions
- Motor Activity
- Being tested
- Walking program
- Keywords
- Low income population, Motor Activity, Primary Health Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking programBehavioural
To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Walking program |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire
Physical activity level evaluated through the International Physical Activity Questionnaire
Measured: six months
Objective evaluation of physical activity level evaluated through accelerometer device
Physical activity level evaluated through accelerometer device
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Grace Angélica de Oliveira Gomes, Universidade Federal de Sao Carlos
- Investigators
- Grace AO Gomes, Doctor, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857127
- Sponsor's protocol ID
- FAPESP14/03909-2
- Status last verified
- Aug 2016
- First submitted
- 30 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baba CT, Oliveira IM, Silva AEF, Vieira LM, Cerri NC, Florindo AA, de Oliveira Gomes GA. Evaluating the impact of a walking program in a disadvantaged area: using the RE-AIM framework by mixed methods. BMC Public Health. 2017 Sep 15;17(1):709. doi: 10.1186/s12889-017-4698-5.
PubMed 28915827
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Physical Activity for Vulnerable Adults and Elderly People: Evaluation of a Walking Program in Primary Care Settings
- ClinicalTrials.gov ID
- NCT02857127
- Acronym / sponsor ID
- FAPESP14/03909-2
- Conditions
- Motor Activity
- Keywords
- Low income population, Motor Activity, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A quasi experimental study evaluating the effectiveness of a walking program at primary health care settings in a low-income area
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Walking programA 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- To participate only in one day of intervention
- To have less than 75% of presence in the intervention
- To give up of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking programTo encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up. | Behavioural | Intervention Group |
Primary outcome
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
Objective evaluation of physical activity level evaluated through accelerometer device
Time frame: six months
Physical activity level evaluated through accelerometer device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Derived from this study: PubMed 28915827Baba CT, Oliveira IM, Silva AEF, Vieira LM, Cerri NC, Florindo AA, de Oliveira Gomes GA. Evaluating the impact of a walking program in a disadvantaged area: using the RE-AIM framework by mixed methods. BMC Public Health. 2017 Sep 15;17(1):709. doi: 10.1186/s12889-017-4698-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace AO Gomes, Doctor principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking program in people with Motor Activity, run by Universidade Federal de Sao Carlos at 1 site 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 5 inclusion and 3 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 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Subjective evaluation of physical activity level evaluated through the International Physical Activity Questionnaire (time frame: six 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 NCT02857127, 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 5 Aug 2016.