<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257268</url>
  </required_header>
  <id_info>
    <org_study_id>VAMOS REC 01</org_study_id>
    <nct_id>NCT02257268</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Program for Physical Activity and Healthy Eating Promotion in Hypertensives</brief_title>
  <official_title>Effectiveness of VAMOS - a Change Behavior Program for Physical Activity and Healthy Eating Promotion - in Hypertensives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Santa Catarina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Santa Catarina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical&#xD;
      activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco-&#xD;
      Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive&#xD;
      medication and classified as non-physically active, will be selected and randomly distributed&#xD;
      into two groups: a change behavior group (CBG) and control group (CG). The CBG will&#xD;
      participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for&#xD;
      12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly&#xD;
      meeting, will be presented and discussed guidelines and strategies for practical physical&#xD;
      activities in different fields and for adoption of a healthy diet in order that the level of&#xD;
      physical activity and eating quality improve. The program will be evaluated by effectiveness,&#xD;
      implementation and maintenance (initial and individual level) dimensions of RE-AIM framework.&#xD;
      The effectiveness will be assessed from anthropometric measurements, body composition, eating&#xD;
      habits, physical activity level, stages of self-change, self-efficacy, social support,&#xD;
      quality of life and assessment of cardiovascular function at rest (clinic and home blood&#xD;
      pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart&#xD;
      rate variability) before and after 12 weeks of intervention. The implementation will be&#xD;
      assessed by identifying the extent to which the program will be conducted as planned. The&#xD;
      maintenance, initial and at individual level, will be estimated from revaluations of all&#xD;
      outcomes, as measured before and after the intervention, three months after the end of the&#xD;
      program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed&#xD;
      models wil be applied for for within and between groups comparison, if the premises of this&#xD;
      test are met. The level of significance that will be adopted is P&lt;0.05. All analyzes will be&#xD;
      done at SPSS statistical package, version 17.0.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this study is to evaluate the effectiveness of VAMOS program, a physical&#xD;
      activity and healthy eating promotion program, in hypertensive from Recife-PE- Brazil. As&#xD;
      secondaries goals, the study attempts to:&#xD;
&#xD;
        1. evaluate the effectiveness of VAMOS program with regard to physical activity, the&#xD;
           sedentary behavior and eating habits in hypertensives;&#xD;
&#xD;
        2. analyze whether self-efficacy, stages of self-change and social support mediate the&#xD;
           possible effects of VAMOS program on physical activity, sedentary behavior and eating&#xD;
           habits in hypertensives;&#xD;
&#xD;
        3. evaluate the effectiveness of VAMOS program with regard to clinic and home blood&#xD;
           pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and&#xD;
           heart rate variability in hypertensives;&#xD;
&#xD;
        4. evaluate the effectiveness of VAMOS program on anthropometric and body composition&#xD;
           variables in hypertensives;&#xD;
&#xD;
        5. analyze whether the possible result changes brought from VAMOS program in behavioral and&#xD;
           biological variables promote changes in quality of life of hypertensives;&#xD;
&#xD;
        6. assess the implementation of VAMOS program in nonpharmacological treatment of&#xD;
           hypertension in Recife, northeastern of Brazil;&#xD;
&#xD;
        7. identify whether the possible effects achieved from VAMOS remain three months after the&#xD;
           end of the program in hypertensives.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in clinic blood pressure</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be checked using an automatic oscillometric instrument (Omron HEM 742-E0 - USA). The patients will be instructed to eat a light meal before the measurements, to avoid physical exercise and alcohol ingestion for at least 24 hours prior to the visit, and to avoid smoking and caffeine for at least 12 hours. Measurements will be taken in two non-consecutive days, after 10 minutes of rest in the supine position and three measurements will be done in each day, with one minute interval between measurements. All measurements will be taken on the left arm, in a quiet environment, with monitored temperature.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in physical activity</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>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 &quot;accelerometer not worn&quot; 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in eating habits</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Eating habits will be investigated from the number of meals daily, quality chewing food, dietary intake concomitantly liquids at mealtimes, habit of eating salads, raw or cooked vegetables, daily water consumption habits and intake of visible fat from meat and chicken. Also, the food frequency questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in anthropometric parameters</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Body mass will be measured with participants wearing light clothes and no shoes, using an automatic scale (Welmy - Brazil) to the nearest 0.1 kg. Height will be measured using a stadiometer connected to scale to the nearest 0.5 cm. Body mass index will be calculated as the ratio between body mass in kilograms and the square of height in meters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in body composition</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Total body fat and body fat trunk will be estimated by densitometry scans for dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy DXA, model NRL 41990, GE Lunar, Madison, WI). For the assessment, participants will be instructed to remain clothed but to remove any metallic prosthesis or objects. The procedure will last five to ten minutes for each individual and will be carried out by the same technician who will calibrate the device according to the manufacturer's recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in arterial stiffness</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Pulse wave analyses, to obtain augmentation index, central systolic blood pressure, diastolic blood pressure and carotid-femoral pulse wave velocity will be measured using Sphygmocor (Atcor Medical, Sydney, Australia). The measurement of these parameters will be done according to guidelines specified by the Clinical Application of Arterial stiffness, Task Force III.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in heart rate variability</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>For heart rate variability assessment, R-R interval will be obtained using a heart rate monitor (POLAR, RS 800CX; Polar Electro Oy Inc, Kempele, Finland). Participants should remain in the supine position for 10 minutes, after approximately 10 minutes at rest. All analyses will be performed with Kubios software (Biosignal Analysis and Medical Imaging Group - Finland) by a single evaluator, following the recommendations of the Task Force of the European Society of Cardiology and the North American.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in blood flow and flow-mediated dilation</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>For assessment of blood flow and flow-mediated dilation, the method of venous occlusion pletysmography will be used (Hokanson - EC6 - EUA) with measurement being done in the left arm. A cuff will be placed around the left arm and another cuff will be placed around the wrist. A strain gauge pletysmography will be positioned in the largest forearm circumference. For blood flow measurement, the wrist cuff will be inflated and then the arm cuff for 10 seconds, followed by 10 seconds of deflation, totaling 20 seconds in each cycle. Inflation of the cuff will be made during the cardiac diastole, which will be perceived by an electrocardiogram. The measurement will be performed 12 times in a row, completing four minutes. The flow-mediated vasodilation will be assessed by vascular response to vasodilator stimuli using the technique of reactive hyperemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in home blood pressure monitoring</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>Each participant will receive an automatic device (OMRON - HEM - 742INT) and will be instructed to perform over four days, four measures of blood pressure at home, two in the morning and two at night. They will be instructed to taking five minutes of rest and one minute of interval between measurements. In addition, subjects will be instructed to perform the steps before taking the medicaments and before breakfast or dinner, following the recommendations of III Guidelines for Home Blood Pressure Monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in stages of self-changes</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>The stages of self-changes for physical activity and for healthy eating habits will be assessed by questionnaires that classified subjects in one of five stages: pre-contemplation, contemplation, preparation, action and maintenance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in self-efficacy</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>The self-efficacy will be evaluated by scale &quot;Self-Efficacy to Regulate Eating Habits e Self-Efficacy to Regulate Exercise&quot; proposed by Bandura (2006) and validated for Brazilian adults by Boff (2012).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in social support</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>The social support for physical activities will be evaluated by a scale proposed by Reis et al. (2011).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>baseline, 12 weeks, 24 weeks</time_frame>
    <description>The quality of life will be assessed by two general questions from Whoqol BREF.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Change behavior group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Change behavior group = Group of change behavior including physical activity and healthy habits promotion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group = Group that will not receive the VAMOS program as intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>VAMOS program - Active life improving health</intervention_name>
    <description>All participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for 12 weeks. VAMOS is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by a weekly meeting, in group, lasting about 90 min. 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. The participants of this group will receive an educational material and, in the middle of the program, they will earn a pedometer to aid in motivation and in the self-monitoring physical activity.</description>
    <arm_group_label>Change behavior group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of hypertension;&#xD;
&#xD;
          -  Must be under anti-hypertensive medications for three months or more;&#xD;
&#xD;
          -  May not present diabetes or other cardiovascular diseases;&#xD;
&#xD;
          -  May not be engaged in regular physical activity;&#xD;
&#xD;
          -  May not have physical disabilities that compromise the physical activity practices.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not agree to participated with study;&#xD;
&#xD;
          -  Not agree to sign the written informed consent;&#xD;
&#xD;
          -  Change in doses or type of anti-hypertensive medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raphael M Ritti-Dias, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>University of Pernambuco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tania Rosane B Benedetti, Doctor</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of Santa Catarina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aline M Gerage, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Santa Catarina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aline Mendes Gerage</name>
      <address>
        <city>Florianopolis</city>
        <state>Santa Catarina</state>
        <zip>88037-610</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>August 18, 2015</last_update_submitted>
  <last_update_submitted_qc>August 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Santa Catarina</investigator_affiliation>
    <investigator_full_name>Aline Mendes Gerage</investigator_full_name>
    <investigator_title>PhD student</investigator_title>
  </responsible_party>
  <keyword>health behavior; risk factors;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257268
org study id: VAMOS REC 01
nct id: NCT02257268
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical
      activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco-
      Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive
      medication and classified as non-physically active, will be selected and randomly distributed
      into two groups: a change behavior group (CBG) and control group (CG). The CBG will
      participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for
      12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly
      meeting, will be presented and discussed guidelines and strategies for practical physical
      activities in different fields and for adoption of a healthy diet in order that the level of
      physical activity and eating quality improve. The program will be evaluated by effectiveness,
      implementation and maintenance (initial and individual level) dimensions of RE-AIM framework.
      The effectiveness will be assessed from anthropometric measurements, body composition, eating
      habits, physical activity level, stages of self-change, self-efficacy, social support,
      quality of life and assessment of cardiovascular function at rest (clinic and home blood
      pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart
      rate variability) before and after 12 weeks of intervention. The implementation will be
      assessed by identifying the extent to which the program will be conducted as planned. The
      maintenance, initial and at individual level, will be estimated from revaluations of all
      outcomes, as measured before and after the intervention, three months after the end of the
      program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed
      models wil be applied for 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.
The overall goal of this study is to evaluate the effectiveness of VAMOS program, a physical
      activity and healthy eating promotion program, in hypertensive from Recife-PE- Brazil. As
      secondaries goals, the study attempts to:

        1. evaluate the effectiveness of VAMOS program with regard to physical activity, the
           sedentary behavior and eating habits in hypertensives;

        2. analyze whether self-efficacy, stages of self-change and social support mediate the
           possible effects of VAMOS program on physical activity, sedentary behavior and eating
           habits in hypertensives;

        3. evaluate the effectiveness of VAMOS program with regard to clinic and home blood
           pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and
           heart rate variability in hypertensives;

        4. evaluate the effectiveness of VAMOS program on anthropometric and body composition
           variables in hypertensives;

        5. analyze whether the possible result changes brought from VAMOS program in behavioral and
           biological variables promote changes in quality of life of hypertensives;

        6. assess the implementation of VAMOS program in nonpharmacological treatment of
           hypertension in Recife, northeastern of Brazil;

        7. identify whether the possible effects achieved from VAMOS remain three months after the
           end of the program in hypertensives.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: change in clinic blood pressure
time frame: baseline, 12 weeks, 24 weeks
description: Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be checked using an automatic oscillometric instrument (Omron HEM 742-E0 - USA). The patients will be instructed to eat a light meal before the measurements, to avoid physical exercise and alcohol ingestion for at least 24 hours prior to the visit, and to avoid smoking and caffeine for at least 12 hours. Measurements will be taken in two non-consecutive days, after 10 minutes of rest in the supine position and three measurements will be done in each day, with one minute interval between measurements. All measurements will be taken on the left arm, in a quiet environment, with monitored temperature.
measure: change in physical activity
time frame: baseline, 12 weeks, 24 weeks
description: 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.
measure: change in eating habits
time frame: baseline, 12 weeks, 24 weeks
description: Eating habits will be investigated from the number of meals daily, quality chewing food, dietary intake concomitantly liquids at mealtimes, habit of eating salads, raw or cooked vegetables, daily water consumption habits and intake of visible fat from meat and chicken. Also, the food frequency questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.
measure: change in anthropometric parameters
time frame: baseline, 12 weeks, 24 weeks
description: Body mass will be measured with participants wearing light clothes and no shoes, using an automatic scale (Welmy - Brazil) to the nearest 0.1 kg. Height will be measured using a stadiometer connected to scale to the nearest 0.5 cm. Body mass index will be calculated as the ratio between body mass in kilograms and the square of height in meters.
measure: change in body composition
time frame: baseline, 12 weeks, 24 weeks
description: Total body fat and body fat trunk will be estimated by densitometry scans for dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy DXA, model NRL 41990, GE Lunar, Madison, WI). For the assessment, participants will be instructed to remain clothed but to remove any metallic prosthesis or objects. The procedure will last five to ten minutes for each individual and will be carried out by the same technician who will calibrate the device according to the manufacturer's recommendations.
measure: change in arterial stiffness
time frame: baseline, 12 weeks, 24 weeks
description: Pulse wave analyses, to obtain augmentation index, central systolic blood pressure, diastolic blood pressure and carotid-femoral pulse wave velocity will be measured using Sphygmocor (Atcor Medical, Sydney, Australia). The measurement of these parameters will be done according to guidelines specified by the Clinical Application of Arterial stiffness, Task Force III.
measure: change in heart rate variability
time frame: baseline, 12 weeks, 24 weeks
description: For heart rate variability assessment, R-R interval will be obtained using a heart rate monitor (POLAR, RS 800CX; Polar Electro Oy Inc, Kempele, Finland). Participants should remain in the supine position for 10 minutes, after approximately 10 minutes at rest. All analyses will be performed with Kubios software (Biosignal Analysis and Medical Imaging Group - Finland) by a single evaluator, following the recommendations of the Task Force of the European Society of Cardiology and the North American.
measure: change in blood flow and flow-mediated dilation
time frame: baseline, 12 weeks, 24 weeks
description: For assessment of blood flow and flow-mediated dilation, the method of venous occlusion pletysmography will be used (Hokanson - EC6 - EUA) with measurement being done in the left arm. A cuff will be placed around the left arm and another cuff will be placed around the wrist. A strain gauge pletysmography will be positioned in the largest forearm circumference. For blood flow measurement, the wrist cuff will be inflated and then the arm cuff for 10 seconds, followed by 10 seconds of deflation, totaling 20 seconds in each cycle. Inflation of the cuff will be made during the cardiac diastole, which will be perceived by an electrocardiogram. The measurement will be performed 12 times in a row, completing four minutes. The flow-mediated vasodilation will be assessed by vascular response to vasodilator stimuli using the technique of reactive hyperemia.
measure: change in home blood pressure monitoring
time frame: baseline, 12 weeks, 24 weeks
description: Each participant will receive an automatic device (OMRON - HEM - 742INT) and will be instructed to perform over four days, four measures of blood pressure at home, two in the morning and two at night. They will be instructed to taking five minutes of rest and one minute of interval between measurements. In addition, subjects will be instructed to perform the steps before taking the medicaments and before breakfast or dinner, following the recommendations of III Guidelines for Home Blood Pressure Monitoring.
measure: change in stages of self-changes
time frame: baseline, 12 weeks, 24 weeks
description: The stages of self-changes for physical activity and for healthy eating habits will be assessed by questionnaires that classified subjects in one of five stages: pre-contemplation, contemplation, preparation, action and maintenance.
measure: change in self-efficacy
time frame: baseline, 12 weeks, 24 weeks
description: The self-efficacy will be evaluated by scale "Self-Efficacy to Regulate Eating Habits e Self-Efficacy to Regulate Exercise" proposed by Bandura (2006) and validated for Brazilian adults by Boff (2012).
measure: change in social support
time frame: baseline, 12 weeks, 24 weeks
description: The social support for physical activities will be evaluated by a scale proposed by Reis et al. (2011).
measure: change in quality of life
time frame: baseline, 12 weeks, 24 weeks
description: The quality of life will be assessed by two general questions from Whoqol BREF.
arm group label: Change behavior group
arm group type: Experimental
description: Change behavior group = Group of change behavior including physical activity and healthy habits promotion.
arm group label: Control group
arm group type: No Intervention
description: Control group = Group that will not receive the VAMOS program as intervention.
intervention type: Behavioral
intervention name: VAMOS program - Active life improving health
description: All participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for 12 weeks. VAMOS is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by a weekly meeting, in group, lasting about 90 min. 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. The participants of this group will receive an educational material and, in the middle of the program, they will earn a pedometer to aid in motivation and in the self-monitoring physical activity.
arm group label: Change behavior group
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Raphael M Ritti-Dias, Doctor
role: Study Director
affiliation: University of Pernambuco
last name: Tania Rosane B Benedetti, Doctor
role: Study Director
affiliation: Federal University of Santa Catarina
last name: Aline M Gerage, PhD student
role: Principal Investigator
affiliation: Federal University of Santa Catarina
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Santa Catarina
investigator full name: Aline Mendes Gerage
investigator title: PhD student
mesh term: Hypertension