Effectiveness of VAMOS - a Change Behavior Program for Physical Activity and Healthy Eating Promotion - in Hypertensives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- change in eating habits
研究概览
简要总结
The main purpose of this study is to evaluate the effectiveness of VAMOS program, a physical activity and healthy eating promotion program, in hypertensive from Recife-Pernambuco- Brazil. Approximately 90 subjects with a diagnosis of hypertension, under anti-hypertensive medication and classified as non-physically active, will be selected and randomly distributed into two groups: a change behavior group (CBG) and control group (CG). The CBG will participate of a change behavior program, entitled VAMOS - Active Life Improving Health, for 12 weeks and composed of a weekly meeting, in group, lasting about 90 minutes. In each weekly meeting, will be presented and discussed guidelines and strategies for practical physical activities in different fields and for adoption of a healthy diet in order that the level of physical activity and eating quality improve. The program will be evaluated by effectiveness, implementation and maintenance (initial and individual level) dimensions of RE-AIM framework. The effectiveness will be assessed from anthropometric measurements, body composition, eating habits, physical activity level, stages of self-change, self-efficacy, social support, quality of life and assessment of cardiovascular function at rest (clinic and home blood pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart rate variability) before and after 12 weeks of intervention. The implementation will be assessed by identifying the extent to which the program will be conducted as planned. The maintenance, initial and at individual level, will be estimated from revaluations of all outcomes, as measured before and after the intervention, three months after the end of the program. For data analysis, in addition to descriptive statistics, two-way ANOVA for mixed models wil be applied for 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.
详细描述
The overall goal of this study is to evaluate the effectiveness of VAMOS program, a physical activity and healthy eating promotion program, in hypertensive from Recife-PE- Brazil. As secondaries goals, the study attempts to:
- evaluate the effectiveness of VAMOS program with regard to physical activity, the sedentary behavior and eating habits in hypertensives;
- analyze whether self-efficacy, stages of self-change and social support mediate the possible effects of VAMOS program on physical activity, sedentary behavior and eating habits in hypertensives;
- evaluate the effectiveness of VAMOS program with regard to clinic and home blood pressure, arterial stiffness, blood flow and flow-mediated dilation, heart rate and heart rate variability in hypertensives;
- evaluate the effectiveness of VAMOS program on anthropometric and body composition variables in hypertensives;
- analyze whether the possible result changes brought from VAMOS program in behavioral and biological variables promote changes in quality of life of hypertensives;
- assess the implementation of VAMOS program in nonpharmacological treatment of hypertension in Recife, northeastern of Brazil;
- identify whether the possible effects achieved from VAMOS remain three months after the end of the program in hypertensives.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of hypertension;
- •Must be under anti-hypertensive medications for three months or more;
- •May not present diabetes or other cardiovascular diseases;
- •May not be engaged in regular physical activity;
- •May not have physical disabilities that compromise the physical activity practices.
排除标准
- •Not agree to participated with study;
- •Not agree to sign the written informed consent;
- •Change in doses or type of anti-hypertensive medications.
研究组 & 干预措施
Change behavior group
Change behavior group = Group of change behavior including physical activity and healthy habits promotion.
干预措施: VAMOS program - Active life improving health (Behavioral)
Control group
Control group = Group that will not receive the VAMOS program as intervention.
结局指标
主要结局
change in eating habits
时间窗: baseline, 12 weeks, 24 weeks
Eating habits will be investigated from the number of meals daily, quality chewing food, dietary intake concomitantly liquids at mealtimes, habit of eating salads, raw or cooked vegetables, daily water consumption habits and intake of visible fat from meat and chicken. Also, the food frequency questionnaire will be applied, using a list of foods for which the average frequency of consumption over the last three months is given.
change in clinic blood pressure
时间窗: baseline, 12 weeks, 24 weeks
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be checked using an automatic oscillometric instrument (Omron HEM 742-E0 - USA). The patients will be instructed to eat a light meal before the measurements, to avoid physical exercise and alcohol ingestion for at least 24 hours prior to the visit, and to avoid smoking and caffeine for at least 12 hours. Measurements will be taken in two non-consecutive days, after 10 minutes of rest in the supine position and three measurements will be done in each day, with one minute interval between measurements. All measurements will be taken on the left arm, in a quiet environment, with monitored temperature.
change in physical activity
时间窗: baseline, 12 weeks, 24 weeks
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.
次要结局
- change in heart rate variability(baseline, 12 weeks, 24 weeks)
- change in home blood pressure monitoring(baseline, 12 weeks, 24 weeks)
- change in blood flow and flow-mediated dilation(baseline, 12 weeks, 24 weeks)
- change in stages of self-changes(baseline, 12 weeks, 24 weeks)
- change in body composition(baseline, 12 weeks, 24 weeks)
- change in self-efficacy(baseline, 12 weeks, 24 weeks)
- change in social support(baseline, 12 weeks, 24 weeks)
- change in quality of life(baseline, 12 weeks, 24 weeks)
- change in anthropometric parameters(baseline, 12 weeks, 24 weeks)
- change in arterial stiffness(baseline, 12 weeks, 24 weeks)
研究者
Aline Mendes Gerage
PhD student
Universidade Federal de Santa Catarina