Clinical trial NCT02823301: VAMOS Program at Different Environments of Florianópolis
Official title: Implementation of VAMOS Program at Health Centers of Florianópolis: Analysis of Different Environments Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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".

Exclusion Criteria:

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

Primary outcomes:
measure: change in physical activity
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in eating habits
timeFrame: baseline, 5 months, 11 months, 17 months
Secondary outcomes:
measure: change in body mass
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in body mass index
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in waist and hip circumference
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in self-efficacy for physical activity
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in self-efficacy for eating habits
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in social-support for physical activity
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in social-support for eating habits
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in quality of life
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in fasting glucose
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in total cholesterol
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in HDL-cholesterol
timeFrame: baseline, 5 months, 11 months, 17 months
measure: change in triglycerides
timeFrame: baseline, 5 months, 11 months, 17 months
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Federal University of Santa Catarina
name: Tania R Benedetti, doctor
role: STUDY_DIRECTOR
affiliation: Federal University of Santa Catarina
name: Cassiano R Rech, doctor
role: STUDY_DIRECTOR
References: