跳至主要内容
临床试验/NCT02823301
NCT02823301已完成不适用

Implementation of VAMOS Program at Health Centers of Florianópolis: Analysis of Different Environments Settings

Universidade Federal de Santa Catarina1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
change in physical activity

研究概览

简要总结

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program.

详细描述

The main purpose of this study is to evaluate the effectiveness and the maintenance of a behavior change program called VAMOS (Active Life Improving Health) Program on physical activity and healthy eating habits in different environmental contexts of Florianópolis/ SC/ Brazil. This study will be conducted in Health Centers (HC) of Florianópolis/ SC/ Brazil, defined according to environmental and income characteristics. Therefore, initially all geographic areas around the HC will be visited to classify the public places as favorable (with the presence of spaces for the practice of PA) and unfavorable environmental (do not have spaces for physical activity), using the instrument Physical Activity Resource Assessment (PARA). Thereafter, four HC will be selected: high income + high environmental quality index, high income + low environmental quality index, low income + high environmental quality index, low income + low environmental quality index. In each HC, the volunteers will be randomly assigned into two groups of approximately 25 people: VAMOS group and control group, resulting in a total sample of approximately 200 volunteer users. The volunteers will be invited to attend a lecture on healthy lifestyle in date, place and time set, in which a screening will be held in order to trace the profile of the population reached. On this occasion, a questionnaire containing information of sociodemographic data, health status, quality of life, physical activity, eating habits will be answered. They also will be asked to report their individual height and body mass. The participants that will be assigned to the VAMOS group will participate in a behavioral change program aimed at motivating changes in physical activity and eating habits during five months (12 meetings - six weekly meetings and six fortnightly meetings), while the control group will receive one educational lecture regarding lifestyle changes. The meetings of VAMOS Program will be held in the dependences or nearby the HC and will be mediated by the physical education professional previously trained. The Program will be evaluated by the RE-AIM framework: reach, effectiveness, adoption, implementation and maintenance. The effectiveness will be assessed from measurements of physical activity, eating habits, self-efficacy, social support, quality of life, anthropometry, and lipid profile before and after five months of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance will be estimated from revaluations of all outcomes, as measured before and after the intervention, six months and one year after the end of the program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed models will be applied 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.

研究设计

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

入排标准

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

入选标准

  • •Must be registered in the public health system;
  • •Must have been attended on health center at least one time during the last six months;
  • •Must be classified as " insufficiently active".

排除标准

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

研究组 & 干预措施

VAMOS group

Experimental

Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each 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.

干预措施: VAMOS Program (Behavioral)

Control group

No Intervention

Group that will not receive the VAMOS program as intervention.

结局指标

主要结局

change in physical activity

时间窗: baseline, 5 months, 11 months, 17 months

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

change in eating habits

时间窗: baseline, 5 months, 11 months, 17 months

Eating habits will be investigated from the score generated by the food frequency questionnaire, using questions from previous studies (Brasil, 2014; Lopes, 2010). The questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.

次要结局

  • change in body mass(baseline, 5 months, 11 months, 17 months)
  • change in body mass index(baseline, 5 months, 11 months, 17 months)
  • change in waist and hip circumference(baseline, 5 months, 11 months, 17 months)
  • change in triglycerides(baseline, 5 months, 11 months, 17 months)
  • change in quality of life(baseline, 5 months, 11 months, 17 months)
  • change in self-efficacy for physical activity(baseline, 5 months, 11 months, 17 months)
  • change in self-efficacy for eating habits(baseline, 5 months, 11 months, 17 months)
  • change in social-support for physical activity(baseline, 5 months, 11 months, 17 months)
  • change in fasting glucose(baseline, 5 months, 11 months, 17 months)
  • change in HDL-cholesterol(baseline, 5 months, 11 months, 17 months)
  • change in social-support for eating habits(baseline, 5 months, 11 months, 17 months)
  • change in total cholesterol(baseline, 5 months, 11 months, 17 months)

研究者

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

Aline Mendes Gerage

PhD student

Universidade Federal de Santa Catarina

研究点 (1)

Loading locations...

相似试验