VAMOS Program at Different Environments of Florianópolis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sedentary Lifestyle

Intervention / Treatment
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* Behavioral: VAMOS Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VAMOS group<br>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. | Behavioral: VAMOS Program<br>* 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.<br>|
| No Intervention: Control group<br>Group that will not receive the VAMOS program as intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in physical activity | 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 | baseline, 5 months, 11 months, 17 months | 
| change in eating habits | 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. | baseline, 5 months, 11 months, 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in body mass | The body mass (kg) will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011) | baseline, 5 months, 11 months, 17 months | 
| change in body mass index | The body mass index will be calculated with the measurements of body mass and stature that will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011) | baseline, 5 months, 11 months, 17 months | 
| change in waist and hip circumference | The waist and hip circumferences (cm) will be measured according to the recommendations from the International Standards for Anthropometric Assessment (2011) | baseline, 5 months, 11 months, 17 months | 
| change in self-efficacy for physical activity | The self-efficacy for physical activity will be evaluated by a scale proposed by Ammerman et al.(1991). | baseline, 5 months, 11 months, 17 months | 
| change in self-efficacy for eating habits | The self-efficacy for eating habits will be evaluated by a scale proposed by Ammerman et al.(1991). | baseline, 5 months, 11 months, 17 months | 
| change in social-support for physical activity | The social support for physical activity will be evaluated by a scale proposed by Reis et al. (2011). | baseline, 5 months, 11 months, 17 months | 
| change in social-support for eating habits | The social support for eating habits will be evaluated by a scale proposed by Sallis (1987). | baseline, 5 months, 11 months, 17 months | 
| change in quality of life | The quality of life will be assessed by two general questions from Whoqol BREF. | baseline, 5 months, 11 months, 17 months | 
| change in fasting glucose | The fasting glucose will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls. | baseline, 5 months, 11 months, 17 months | 
| change in total cholesterol | The total cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls. | baseline, 5 months, 11 months, 17 months | 
| change in HDL-cholesterol | The HDL-cholesterol will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. The concentration of LDL-cholesterol is calculated using the Friedewald formula. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls. | baseline, 5 months, 11 months, 17 months | 
| change in triglycerides | The lipid profile triglycerides will be determined by blood sample. Venous blood will be collected in vacuum tubes without anticoagulant following the recommendations for venous blood collection with 12 hours of fasting. These measurements will be performed using diagnostic kits according to the manufacturers instructions respecting the internal quality controls. | baseline, 5 months, 11 months, 17 months |