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CompletedNCT02659267VAMOSUpdated Apr 8, 2016

Evaluation of a Strategy Designed to Promote Physical and Healthy Eating

An interventional study of Interventions Group in Healthy, sponsored by Universidade Federal de Santa Catarina. Completed at 1 site in Brazil. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-08.

Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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 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:

  1. Evaluate the effectiveness of VAMOS strategy on the level of habitual physical activity, dietary profile and nutritional status of the participants;
  2. To identify associations between psychosocial mediators of behavior - self-efficacy and social support - and changes in physical activity and dietary profile of the participants;
  3. Analyze the VAMOS strategy regarding the effectiveness, adoption (at individual level), reach, implementation and maintenance.
02

Conditions studied

  • Healthy

Keywords

  • Health Promotion
  • Physical Activity
  • Eating habits
  • Health System
  • Users from Health Academy Program
03

In context

Lead sponsor

Universidade Federal de Santa Catarina is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be user of de Health Academy Program selected for the survey;
  • Must have 20 years or older;

Exclusion criteria

Exclusion Criteria:

  • Not agree to participated with study;
  • Not agree to sign the written informed consent;
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
256 participants (actual)

Study arms

  • Experimental
    Interventions Group=

    Group of change behavior including physical activity and healthy eating habits promotion.

    Behavioral: Interventions Group

  • No intervention
    Control Group=

    Group that will not receive the VAMOS program as intervention, only participate in the Health Academy Program Activities.

Interventions

  • BehavioralInterventions Group

    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.

    Also known as: VAMOS

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline, 12 weeks, 36 weeks

  2. 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.

    Time frame: baseline, 12 weeks, 36 weeks

  3. 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.

    Time frame: baseline, 12 weeks, 36 weeks

  4. change in waist circumference

    Waist circumference is measured at the lesser curvature identified between the last rib and the iliac crest.

    Time frame: baseline, 12 weeks, 36 weeks

  5. change in hip circumference

    Hip circumference is measured in the area of larger diameter of the hip, without compressing the skin.

    Time frame: baseline, 12 weeks, 36 weeks

  6. 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.

    Time frame: baseline, 12 weeks, 36 weeks

Secondary outcomes

  1. 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.

    Time frame: baseline, 12 weeks, 36 weeks

  2. 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.

    Time frame: baseline, 12 weeks, 36 weeks

  3. 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).

    Time frame: baseline, 12 weeks

  4. change in social support

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

    Time frame: baseline, 12 weeks

  5. change in quality of life

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

    Time frame: baseline, 12 weeks, 36 weeks

07

Study locations

1 site
  • Simone Teresinha Meurer
    Belo Horizonte, MG 31310480, Brazil
08

References and documents

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 21412569 ↗
  • Fleck 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02659267
Lead sponsor
Universidade Federal de Santa Catarina
Collaborators
Federal University of Minas Gerais
Responsible party
Simone Teresinha Meurer (PHD student, Universidade Federal de Santa Catarina) — Principal investigator
First posted
Jan 20, 2016
Start date
Oct 2014
Primary completion
Jul 2015
Completion
Mar 2016
Last update
Apr 8, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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