HealthyVAMOSNCT02659267
Evaluation of a Strategy Designed to Promote Physical and Healthy Eating
A study testing Interventions Group in people with Healthy, run by Universidade Federal de Santa Catarina at 1 site in Brazil.
Trial summary
The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program from Belo Horizonte, Minas Gerais. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Interventions Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Mar 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be user of de Health Academy Program selected for the survey;
- Must have 20 years or older;
Who cannot join
- Not agree to participated with study;
- Not agree to sign the written informed consent;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Strategy Designed to Promote Physical and Healthy Eating Between Users of the Health Academy Program in Belo Horizonte, Minas Gerais - "VAMOS BEAGÁ"
The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program from Belo Horizonte, Minas Gerais.
Read the detailed description
The Health Academy Program (AP) is a important policy to promote physical activity in Brazil. There are areas with infrastructure, equipment, and human resources to stimulate and guide people doing physical activity in community settings at no cost. The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program (AP) at Belo Horizonte, Minas Gerais - "VAMOS BEAGÁ". Two AP poles, both belonging the same regional administration of the municipality and with the same health vulnerability index were selected. To define the location of the intervention VAMOS was carried draw between the selected centers, and all potentially eligible users invited to participate. Users of the Intervention Group (IG) took part in the daily activities offered by AP and, additionally, for 12 weeks, they attended the educational strategy called VAMOS. The Control Group does only the regular activities of AP. The VAMOS has been evaluated by the dimensions of Reach, Effectiveness, Adoption (at the individual level), Implementation and Maintenance (at individual and organizational level) of the RE-AIM model (Reach, Efficacy / Effectiveness, Adoption, Implementation, Maintenance). The reach is evaluated by the rate of participation and representation among participants and those invited to join the VAMOS. The effectiveness has been evaluated from anthropometric measurements, eating habits, physical activity level, stages of change, self-efficacy, social support and quality of life before and after 12 weeks of intervention. To assess the adoption was investigated the interest of Physical Activity professional from AP in mediating this strategy in future. The implementation was evaluated by identifying the extent to which the VAMOS was conducted as planned. The maintenance, at individual level, will be estimated from revaluations of all outcomes, as measured before and after the intervention, sixs months after the conclusion of the intervention. At organizational level, the maintenance will be accessed with semi-structured interviews conducted with the coordinators and managers of AP assessed feasibility of continuing of VAMOS strategy in AP. For the analysis of qualitative data will be conducted content analysis. And to the quantitative data, we carried out descriptive statistics, paired tests chi-square or Fisher's exact and two-way ANOVA for repeated measures or Wilcoxon signed rank test. Intent-to-treat analyzes were used. The significance level was 5% and the statistical program used was the Statistical Package for Social Sciences (SPSS) for Windows.
The overall goal of this study is to evaluate a strategy to promote physical activity and healthy eating, called VAMOS, among users of the Health Academy Program in Belo Horizonte, Minas Gerais.
Specific objectives:
- Evaluate the effectiveness of VAMOS strategy on the level of habitual physical activity, dietary profile and nutritional status of the participants;
- To identify associations between psychosocial mediators of behavior - self-efficacy and social support - and changes in physical activity and dietary profile of the participants;
- Analyze the VAMOS strategy regarding the effectiveness, adoption (at individual level), reach, implementation and maintenance.
- Conditions
- Healthy
- Being tested
- Interventions Group
- Keywords
- Health Promotion, Physical Activity, Eating habits, Health System, Users from Health Academy Program
- Medical subject headings
- Motor Activity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions GroupBehavioural
Also called VAMOS
VAMOS is a lifestyle promotion strategy, designed to promote physical activity and healthy eating habits. The intervention is composed by a weekly meeting, 12-week, in group, lasting about 60 min. In each weekly meeting, were 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 VAMOS strategy are based in behavior changes theories. The participants of this group received educational material and, in the middle of the program, they received a pedometer to aid in motivation and in the self-monitoring physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Interventions Group= | Experimental | Group of change behavior including physical activity and healthy eating habits promotion. Receives: Behavioral: Interventions Group |
| Control Group= | No intervention | Group that will not receive the VAMOS program as intervention, only participate in the Health Academy Program Activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity
Habitual physical activity has been assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and analysed with Actilife 6.10 software. Each participant was instructed to use the accelerometer on his/her waist for seven consecutive days, removing it only when sleeping, bathing or performing water activities. Attached to an elastic belt, the device had to stay at the right side of the hip. Data are recorded in a 30 Hz sample frequency and analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer are interpreted as "accelerometer not worn" and therefore excluded. Physical activity data are included only if the participant got a minimum of 10 hours/day of recording for at least four days, including at least one weekend day
Measured: baseline, 12 weeks, 36 weeks
change in frequency of consumption of fresh and minimally processed food
The frequency of consumption of raw and cooked vegetables, fruits, milk, pulses, meat, fish and tubers / roots has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 4 points; weekly consumption = 3 points, monthly consumption = 2 points; rare consumption= 1 point; null consumption = 0 point. Higher the resulting score, healthier the consumption.
Measured: baseline, 12 weeks, 36 weeks
change in Body mass index
Body mass has been measured while participants wear light clothes and no shoes, using an automatic scale (Welmy - Brazil) to the nearest 0.1 kg. Height has been measured using a stadiometer connected to scale to the nearest 0.5 cm. Body mass index has been calculated as the ratio between body mass in kilograms and the square of height in meters.
Measured: baseline, 12 weeks, 36 weeks
change in waist circumference
Waist circumference is measured at the lesser curvature identified between the last rib and the iliac crest.
Measured: baseline, 12 weeks, 36 weeks
change in hip circumference
Hip circumference is measured in the area of larger diameter of the hip, without compressing the skin.
Measured: baseline, 12 weeks, 36 weeks
change in consumption of Ultra-Processed food
The frequency of consumption of sausages, sandwich cookies, candy, snacks / fatty snacks, soda, juice powder and industrialized seasoning has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 0 points; weekly consumption= 1 point; monthly consumption = 2 points, rare consumption = 3 points; null consumption = 4 points. Higher the resulting score, healthier the consumption.
Measured: baseline, 12 weeks, 36 weeks
Secondary outcomes (5)
change in stages of self-changes for physical activity
The stages of self-changes for physical activity are assessed by questionnaires that sort subjects in one of five stages: pre-contemplation, contemplation, preparation, action and maintenance.
Measured: baseline, 12 weeks, 36 weeks
change in stages of self-changes for healthy eating habits
The stages of self-changes for healthy eating habits are assessed by questionnaires that classified subjects in one of five stages: pre-contemplation, contemplation, preparation, action and maintenance.
Measured: baseline, 12 weeks, 36 weeks
change in self-efficacy
The self-efficacy are evaluated by scale "Self-Efficacy to Regulate Eating Habits and Self-Efficacy to Regulate Exercise" proposed by Bandura (2006) and validated for Brazilian adults by Boff (2012).
Measured: baseline, 12 weeks
change in social support
The social support for physical activities has been evaluated by a scale proposed by Reis et al. (2011).
Measured: baseline, 12 weeks
change in quality of life
The quality of life is assessed by two general questions from Whoqol BREF.
Measured: baseline, 12 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Responsible party
- Principal investigator, Simone Teresinha Meurer, Universidade Federal de Santa Catarina
- Investigators
- Tânia Rosane B Benedetti, Doctor, Study director, Federal University of Santa CatarinaAline Cristine S Lopes, Doctor, Study director, Federal University of Minas GeraisSimone T Meurer, PHD Student, Principal investigator, Federal University of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659267
- Sponsor's protocol ID
- VAMOS Beagá
- Acronym
- VAMOS
- Status last verified
- Apr 2016
- First submitted
- 11 Jan 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
BOFF, R. de M. Evidências Psicométricas das Escalas de Auto-eficácia para regular hábito alimentar e Auto-eficácia para regular exercício físico. Dissertação (mestrado). Pontífica Universidade Católica do Rio Grande do Sul, Porto Alegre, 2012.
Reis MS, Reis RS, Hallal PC. Validity and reliability of a physical activity social support assessment scale. Rev Saude Publica. 2011 Apr;45(2):294-301. doi: 10.1590/s0034-89102011000200008. English, Portuguese.
PubMed 21412569Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
PubMed 10881154
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Strategy Designed to Promote Physical and Healthy Eating Between Users of the Health Academy Program in Belo Horizonte, Minas Gerais - "VAMOS BEAGÁ"
- ClinicalTrials.gov ID
- NCT02659267
- Acronym / sponsor ID
- VAMOS / VAMOS Beagá
- Conditions
- Healthy
- Keywords
- Health Promotion, Physical Activity, Eating habits, Health System, Users from Health Academy Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Universidade Federal de Santa CatarinaUniversity, hospital or other
- Collaborators
- Federal University of Minas Gerais
- Study start
- Oct 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jan 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.
The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program from Belo Horizonte, Minas Gerais.
Detailed description
The Health Academy Program (AP) is a important policy to promote physical activity in Brazil. There are areas with infrastructure, equipment, and human resources to stimulate and guide people doing physical activity in community settings at no cost. The study aims to verify if the VAMOS strategy contributes to an increase in physical activity and healthy eating habits among users of the Health Academy Program (AP) at Belo Horizonte, Minas Gerais - "VAMOS BEAGÁ". Two AP poles, both belonging the same regional administration of the municipality and with the same health vulnerability index were selected. To define the location of the intervention VAMOS was carried draw between the selected centers, and all potentially eligible users invited to participate. Users of the Intervention Group (IG) took part in the daily activities offered by AP and, additionally, for 12 weeks, they attended the educational strategy called VAMOS. The Control Group does only the regular activities of AP. The VAMOS has been evaluated by the dimensions of Reach, Effectiveness, Adoption (at the individual level), Implementation and Maintenance (at individual and organizational level) of the RE-AIM model (Reach, Efficacy / Effectiveness, Adoption, Implementation, Maintenance). The reach is evaluated by the rate of participation and representation among participants and those invited to join the VAMOS. The effectiveness has been evaluated from anthropometric measurements, eating habits, physical activity level, stages of change, self-efficacy, social support and quality of life before and after 12 weeks of intervention. To assess the adoption was investigated the interest of Physical Activity professional from AP in mediating this strategy in future. The implementation was evaluated by identifying the extent to which the VAMOS was conducted as planned. The maintenance, at individual level, will be estimated from revaluations of all outcomes, as measured before and after the intervention, sixs months after the conclusion of the intervention. At organizational level, the maintenance will be accessed with semi-structured interviews conducted with the coordinators and managers of AP assessed feasibility of continuing of VAMOS strategy in AP. For the analysis of qualitative data will be conducted content analysis. And to the quantitative data, we carried out descriptive statistics, paired tests chi-square or Fisher's exact and two-way ANOVA for repeated measures or Wilcoxon signed rank test. Intent-to-treat analyzes were used. The significance level was 5% and the statistical program used was the Statistical Package for Social Sciences (SPSS) for Windows.
The overall goal of this study is to evaluate a strategy to promote physical activity and healthy eating, called VAMOS, among users of the Health Academy Program in Belo Horizonte, Minas Gerais.
Specific objectives:
- Evaluate the effectiveness of VAMOS strategy on the level of habitual physical activity, dietary profile and nutritional status of the participants;
- To identify associations between psychosocial mediators of behavior - self-efficacy and social support - and changes in physical activity and dietary profile of the participants;
- Analyze the VAMOS strategy regarding the effectiveness, adoption (at individual level), reach, implementation and maintenance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventions Group= | Experimental | Behavioral: Interventions GroupGroup of change behavior including physical activity and healthy eating habits promotion. |
| Control Group= | No intervention | –Group that will not receive the VAMOS program as intervention, only participate in the Health Academy Program Activities. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be user of de Health Academy Program selected for the survey;
- Must have 20 years or older;
Key exclusion criteria (2 listed)
- Not agree to participated with 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 |
|---|---|---|
| Interventions GroupAlso: VAMOSVAMOS is a lifestyle promotion strategy, designed to promote physical activity and healthy eating habits. The intervention is composed by a weekly meeting, 12-week, in group, lasting about 60 min. In each weekly meeting, were 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 VAMOS strategy are based in behavior changes theories. The participants of this group received educational material and, in the middle of the program, they received a pedometer to aid in motivation and in the self-monitoring physical activity. | Behavioural | Interventions Group= |
Primary outcome
change in physical activity
Time frame: baseline, 12 weeks, 36 weeks
Habitual physical activity has been assessed by GT3X or GT3X+ accelerometer (Actigraph - USA) and analysed with Actilife 6.10 software. Each participant was instructed to use the accelerometer on his/her waist for seven consecutive days, removing it only when sleeping, bathing or performing water activities. Attached to an elastic belt, the device had to stay at the right side of the hip. Data are recorded in a 30 Hz sample frequency and analyzed using 60-s epochs. Periods with consecutive values of zero (with 2-min of spike tolerance) for 60 min or longer are interpreted as "accelerometer not worn" and therefore excluded. Physical activity data are included only if the participant got a minimum of 10 hours/day of recording for at least four days, including at least one weekend day
change in frequency of consumption of fresh and minimally processed food
Time frame: baseline, 12 weeks, 36 weeks
The frequency of consumption of raw and cooked vegetables, fruits, milk, pulses, meat, fish and tubers / roots has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 4 points; weekly consumption = 3 points, monthly consumption = 2 points; rare consumption= 1 point; null consumption = 0 point. Higher the resulting score, healthier the consumption.
change in Body mass index
Time frame: baseline, 12 weeks, 36 weeks
Body mass has been measured while participants wear light clothes and no shoes, using an automatic scale (Welmy - Brazil) to the nearest 0.1 kg. Height has been measured using a stadiometer connected to scale to the nearest 0.5 cm. Body mass index has been calculated as the ratio between body mass in kilograms and the square of height in meters.
change in waist circumference
Time frame: baseline, 12 weeks, 36 weeks
Waist circumference is measured at the lesser curvature identified between the last rib and the iliac crest.
change in hip circumference
Time frame: baseline, 12 weeks, 36 weeks
Hip circumference is measured in the area of larger diameter of the hip, without compressing the skin.
change in consumption of Ultra-Processed food
Time frame: baseline, 12 weeks, 36 weeks
The frequency of consumption of sausages, sandwich cookies, candy, snacks / fatty snacks, soda, juice powder and industrialized seasoning has been monitored. The following scores are assigned by means of questionnaire: daily consumption = 0 points; weekly consumption= 1 point; monthly consumption = 2 points, rare consumption = 3 points; null consumption = 4 points. Higher the resulting score, healthier the consumption.
5 secondary outcomes
change in stages of self-changes for physical activity
Time frame: baseline, 12 weeks, 36 weeks
change in stages of self-changes for healthy eating habits
Time frame: baseline, 12 weeks, 36 weeks
change in self-efficacy
Time frame: baseline, 12 weeks
change in social support
Time frame: baseline, 12 weeks
change in quality of life
Time frame: baseline, 12 weeks, 36 weeks
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 8 Apr 2016.
- BackgroundBOFF, R. de M. Evidências Psicométricas das Escalas de Auto-eficácia para regular hábito alimentar e Auto-eficácia para regular exercício físico. Dissertação (mestrado). Pontífica Universidade Católica do Rio Grande do Sul, Porto Alegre, 2012.
- Background: PubMed 21412569Reis MS, Reis RS, Hallal PC. Validity and reliability of a physical activity social support assessment scale. Rev Saude Publica. 2011 Apr;45(2):294-301. doi: 10.1590/s0034-89102011000200008. English, Portuguese.
- Background: PubMed 10881154Fleck MP, Louzada S, Xavier M, Chachamovich E, Vieira G, Santos L, Pinzon V. [Application of the Portuguese version of the abbreviated instrument of quality life WHOQOL-bref]. Rev Saude Publica. 2000 Apr;34(2):178-83. doi: 10.1590/s0034-89102000000200012. Portuguese.
- Individual participant dataSharing planned: Undecided
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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.
Tânia Rosane B Benedetti, Doctor study director
Federal University of Santa Catarina
Aline Cristine S Lopes, Doctor study director
Federal University of Minas Gerais
Simone T Meurer, PHD Student principal investigator
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 Interventions Group in people with Healthy, 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 2 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 8 Apr 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?
change in physical activity (time frame: baseline, 12 weeks, 36 weeks). The study lists 6 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 NCT02659267, which also lists 3 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 8 Apr 2016.