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HypertensionNCT02257268

Effectiveness of a Program for Physical Activity and Healthy Eating Promotion in Hypertensives

A study testing VAMOS program - Active life improving health in people with Hypertension, 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

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Hypertension
What is being tested?
VAMOS program - Active life improving health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteBrazil
Study dates
Oct 2014to Jul 2015
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of hypertension;
  • Must be under anti-hypertensive medications for three months or more;
  • May not present diabetes or other cardiovascular diseases;
  • May not be engaged in regular physical activity;
  • May not have physical disabilities that compromise the physical activity practices.

Who cannot join

  • Not agree to participated with study;
  • Not agree to sign the written informed consent;
  • Change in doses or type of anti-hypertensive medications.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Aline Mendes Gerage

    Florianópolis, Santa Catarina, 88037-610

Other trials in Brazil

About this study

Official title: Effectiveness of VAMOS - a Change Behavior Program for Physical Activity and Healthy Eating Promotion - in Hypertensives

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.

Read the detailed description

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.
Conditions
Hypertension
Being tested
VAMOS program - Active life improving health
Keywords
health behavior; risk factors;
Medical subject headings
Hypertension, Health Behavior

What participants receive

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

  • VAMOS program - Active life improving healthBehavioural

    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.

Study groups in NCT02257268
Study groupRoleWhat they receive
Change behavior groupExperimentalChange behavior group = Group of change behavior including physical activity and healthy habits promotion.
Receives: Behavioral: VAMOS program - Active life improving health
Control groupNo interventionControl group = 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.

  1. change in clinic blood pressure

    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.

    Measured: baseline, 12 weeks, 24 weeks

  2. 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, 12 weeks, 24 weeks

  3. change in eating habits

    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.

    Measured: baseline, 12 weeks, 24 weeks

Secondary outcomes (10)
  1. change in anthropometric parameters

    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.

    Measured: baseline, 12 weeks, 24 weeks

  2. change in body composition

    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.

    Measured: baseline, 12 weeks, 24 weeks

  3. change in arterial stiffness

    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.

    Measured: baseline, 12 weeks, 24 weeks

  4. change in heart rate variability

    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.

    Measured: baseline, 12 weeks, 24 weeks

  5. change in blood flow and flow-mediated dilation

    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.

    Measured: baseline, 12 weeks, 24 weeks

  6. change in home blood pressure monitoring

    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.

    Measured: baseline, 12 weeks, 24 weeks

  7. change in stages of self-changes

    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.

    Measured: baseline, 12 weeks, 24 weeks

  8. change in self-efficacy

    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).

    Measured: baseline, 12 weeks, 24 weeks

  9. change in social support

    The social support for physical activities will be evaluated by a scale proposed by Reis et al. (2011).

    Measured: baseline, 12 weeks, 24 weeks

  10. change in quality of life

    The quality of life will be assessed by two general questions from Whoqol BREF.

    Measured: baseline, 12 weeks, 24 weeks

Timeline

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

  1. First posted6 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2015
  4. Study completionJul 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02257268
Sponsor's protocol ID
VAMOS REC 01
Status last verified
Aug 2015
First submitted
27 Sep 2014
Last updated
19 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Gerage AM, Benedetti TRB, Cavalcante BR, Farah BQ, Ritti-Dias RM. Efficacy of a behavior change program on cardiovascular parameters in patients with hypertension: a randomized controlled trial. Einstein (Sao Paulo). 2020 Jan 31;18:eAO5227. doi: 10.31744/einstein_journal/2020AO5227. eCollection 2020.

    PubMed 32022106
  • Gerage AM, Benedetti TRB, Ritti-Dias RM, Dos Santos ACO, de Souza BCC, Almeida FA. Effectiveness of a Behavior Change Program on Physical Activity and Eating Habits in Patients With Hypertension: A Randomized Controlled Trial. J Phys Act Health. 2017 Dec 1;14(12):943-952. doi: 10.1123/jpah.2016-0268. Epub 2017 Sep 22.

    PubMed 28682707

Questions about this trial

What is this clinical trial studying?

A study testing VAMOS program - Active life improving health in people with Hypertension, 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 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 19 Aug 2015. 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 clinic blood pressure (time frame: baseline, 12 weeks, 24 weeks). The study lists 3 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 NCT02257268, which also lists 2 linked publications.

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 19 Aug 2015.

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