Clinical trial NCT02659267: Evaluation of a Strategy Designed to Promote Physical and Healthy Eating
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Health Promotion
Physical Activity
Eating habits
Health System
Users from Health Academy Program
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
First posted: 2016-01-20
Enrollment: 256
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: change in physical activity
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in frequency of consumption of fresh and minimally processed food
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in Body mass index
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in waist circumference
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in hip circumference
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in consumption of Ultra-Processed food
timeFrame: baseline, 12 weeks, 36 weeks
Secondary outcomes:
measure: change in stages of self-changes for physical activity
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in stages of self-changes for healthy eating habits
timeFrame: baseline, 12 weeks, 36 weeks
measure: change in self-efficacy
timeFrame: baseline, 12 weeks
measure: change in social support
timeFrame: baseline, 12 weeks
measure: change in quality of life
timeFrame: baseline, 12 weeks, 36 weeks
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Simone Teresinha Meurer
state: MG
Study officials:
affiliation: Federal University of Santa Catarina
name: Tânia Rosane B Benedetti, Doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Aline Cristine S Lopes, Doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Santa Catarina
name: Simone T Meurer, PHD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.