Sedentary LifestyleNCT02823301

VAMOS Program at Different Environments of Florianópolis

A study testing VAMOS Program in people with Sedentary Lifestyle, run by Universidade Federal de Santa Catarina at 1 site 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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sedentary Lifestyle
What is being tested?: VAMOS Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteBrazil
Study dates: Jul 2016to Sep 2019
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Must be registered in the public health system;
Must have been attended on health center at least one time during the last six months;
Must be classified as " insufficiently active".

Who cannot join

Not agree to participated to the study;
Not agree to sign the written informed consent.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de Santa Catarina
Florianópolis, Santa Catarina, 88040-900

Other trials in Brazil

About this study

Official title: Implementation of VAMOS Program at Health Centers of Florianópolis: Analysis of Different Environments Settings

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program.

Read the detailed description

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity), using the instrument Physical Activity Resource Assessment (PARA). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group, resulting in a total sample of approximately 200 volunteer users. The volunteers will be invited to attend a lecture on healthy lifestyle in date, place and time set, in which a screening will be held in order to trace the profile of the population reached. On this occasion, a questionnaire containing information of sociodemographic data, health status, quality of life, physical activity, eating habits will be answered. They also will be asked to report their individual height and body mass. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed models will be applied for within and between groups comparison, if the premises of this test are met. The level of significance that will be adopted is P<0.05. All analyzes will be done at SPSS statistical package, version 17.0.

Conditions: Sedentary Lifestyle
Being tested: VAMOS Program
Medical subject headings: Sedentary Behavior

What participants receive

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

VAMOS ProgramBehavioural
Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories.

Study groups in NCT02823301
Study group	Role	What they receive
VAMOS group	Experimental	Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories. Receives: Behavioral: VAMOS Program
Control group	No intervention	Group that will not receive the VAMOS program as intervention.

What is being measured

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

change in physical activity
Habitual physical activity will be assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and Actilife 6.10 software will be used to analysis. Each participant will be instructed to use the accelerometer for seven consecutive days, removing it only for sleeping, bathing or performing water activities. The device will be attached to an elastic belt and fixed in the right side of the hip. Data will be collected in a 30 Hz sample frequency and will be analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer will be interpreted as "accelerometer not worn" and excluded from the analysis. Physical activity data only will be included if the participant accumulate a minimum of 10 hours/day of recording for at least four days, including one weekend day
Measured: baseline, 5 months, 11 months, 17 months
change in eating habits
Eating habits will be investigated from the score generated by the food frequency questionnaire, using questions from previous studies (Brasil, 2014; Lopes, 2010). The questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.
Measured: baseline, 5 months, 11 months, 17 months

Secondary outcomes (12)

change in body mass
The body mass (kg) will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011)
Measured: baseline, 5 months, 11 months, 17 months
change in body mass index
The body mass index will be calculated with the measurements of body mass and stature that will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011)
Measured: baseline, 5 months, 11 months, 17 months
change in waist and hip circumference
The waist and hip circumferences (cm) will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011)
Measured: baseline, 5 months, 11 months, 17 months
change in self-efficacy for physical activity
The self-efficacy for physical activity will be evaluated by a scale proposed by Ammerman et al.(1991).
Measured: baseline, 5 months, 11 months, 17 months
change in self-efficacy for eating habits
The self-efficacy for eating habits will be evaluated by a scale proposed by Ammerman et al.(1991).
Measured: baseline, 5 months, 11 months, 17 months
change in social-support for physical activity
The social support for physical activity will be evaluated by a scale proposed by Reis et al. (2011).
Measured: baseline, 5 months, 11 months, 17 months
change in social-support for eating habits
The social support for eating habits will be evaluated by a scale proposed by Sallis (1987).
Measured: baseline, 5 months, 11 months, 17 months
change in quality of life
The quality of life will be assessed by two general questions from Whoqol BREF.
Measured: baseline, 5 months, 11 months, 17 months
change in fasting glucose
The fasting glucose will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Measured: baseline, 5 months, 11 months, 17 months
change in total cholesterol
The total cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Measured: baseline, 5 months, 11 months, 17 months
change in HDL-cholesterol
The HDL-cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. The concentration of LDL-cholesterol is calculated using the Friedewald formula. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Measured: baseline, 5 months, 11 months, 17 months
change in triglycerides
The lipid profile triglycerides will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls.
Measured: baseline, 5 months, 11 months, 17 months

Timeline

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

Jul 2016Sep 2019

First posted6 Jul 2016 (estimated)
Study startJul 2016
Primary completionSep 2019
Study completionSep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sedentary LifestyleStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02823301
Sponsor's protocol ID: VAMOS 2016
Status last verified: Mar 2020
First submitted: 28 Jun 2016
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sedentary Lifestyle trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation of VAMOS Program at Health Centers of Florianópolis: Analysis of Different Environments Settings
ClinicalTrials.gov ID: NCT02823301
Acronym / sponsor ID: VAMOS 2016
Conditions: Sedentary Lifestyle
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Universidade Federal de Santa CatarinaUniversity, hospital or other
Study start: Jul 2016 (actual)
Primary completion: Sep 2019 (actual)
Study completion: Sep 2019 (actual)
First posted: 6 Jul 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.

Detailed description

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity), using the instrument Physical Activity Resource Assessment (PARA). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group, resulting in a total sample of approximately 200 volunteer users. The volunteers will be invited to attend a lecture on healthy lifestyle in date, place and time set, in which a screening will be held in order to trace the profile of the population reached. On this occasion, a questionnaire containing information of sociodemographic data, health status, quality of life, physical activity, eating habits will be answered. They also will be asked to report their individual height and body mass. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed models will be applied for within and between groups comparison, if the premises of this test are met. The level of significance that will be adopted is P<0.05. All analyzes will be done at SPSS statistical package, version 17.0.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VAMOS group	Experimental	Behavioral: VAMOS ProgramActive life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories.
Control group	No intervention	–Group that will not receive the VAMOS program as intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Must be registered in the public health system;
Must have been attended on health center at least one time during the last six months;
Must be classified as " insufficiently active".

Key exclusion criteria (2 listed)

Not agree to participated to the study;
Not agree to sign the written informed consent.

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
VAMOS ProgramActive life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories.	Behavioural	VAMOS group

Primary outcome

change in physical activity
Time frame: baseline, 5 months, 11 months, 17 months
Habitual physical activity will be assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and Actilife 6.10 software will be used to analysis. Each participant will be instructed to use the accelerometer for seven consecutive days, removing it only for sleeping, bathing or performing water activities. The device will be attached to an elastic belt and fixed in the right side of the hip. Data will be collected in a 30 Hz sample frequency and will be analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer will be interpreted as "accelerometer not worn" and excluded from the analysis. Physical activity data only will be included if the participant accumulate a minimum of 10 hours/day of recording for at least four days, including one weekend day
change in eating habits
Time frame: baseline, 5 months, 11 months, 17 months
Eating habits will be investigated from the score generated by the food frequency questionnaire, using questions from previous studies (Brasil, 2014; Lopes, 2010). The questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.

12 secondary outcomes

change in body mass
Time frame: baseline, 5 months, 11 months, 17 months
change in body mass index
Time frame: baseline, 5 months, 11 months, 17 months
change in waist and hip circumference
Time frame: baseline, 5 months, 11 months, 17 months
change in self-efficacy for physical activity
Time frame: baseline, 5 months, 11 months, 17 months
change in self-efficacy for eating habits
Time frame: baseline, 5 months, 11 months, 17 months
change in social-support for physical activity
Time frame: baseline, 5 months, 11 months, 17 months
change in social-support for eating habits
Time frame: baseline, 5 months, 11 months, 17 months
change in quality of life
Time frame: baseline, 5 months, 11 months, 17 months
change in fasting glucose
Time frame: baseline, 5 months, 11 months, 17 months
change in total cholesterol
Time frame: baseline, 5 months, 11 months, 17 months
change in HDL-cholesterol
Time frame: baseline, 5 months, 11 months, 17 months
change in triglycerides
Time frame: baseline, 5 months, 11 months, 17 months

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 31 Mar 2020.
Individual participant dataSharing planned: Undecided

Related trials for Sedentary Lifestyle

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Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
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Future School of Comprehensive Well-Being
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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.

Tania R Benedetti, doctor study director

Federal University of Santa Catarina

Cassiano R Rech, doctor study director

Federal University of Santa Catarina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing VAMOS Program in people with Sedentary Lifestyle, run by Universidade Federal de Santa Catarina 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 3 inclusion and 2 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 31 Mar 2020. 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?

change in physical activity (time frame: baseline, 5 months, 11 months, 17 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 NCT02823301.

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 31 Mar 2020.