跳至主要内容
临床试验/NCT02659267
NCT02659267已完成不适用

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"

Universidade Federal de Santa Catarina2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
256
试验地点
2
主要终点
change in physical activity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

change in physical activity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • change in stages of self-changes for physical activity(baseline, 12 weeks, 36 weeks)
  • change in stages of self-changes for healthy eating habits(baseline, 12 weeks, 36 weeks)
  • change in self-efficacy(baseline, 12 weeks)
  • change in social support(baseline, 12 weeks)
  • change in quality of life(baseline, 12 weeks, 36 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Teresinha Meurer

PHD student

Universidade Federal de Santa Catarina

研究点 (2)

Loading locations...

相似试验