Evaluation Study of Interventions for Physical Activity Promotion in Primary Health Care/Health Family Strategy in Brazil.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 3
- 主要终点
- Change from baseline leisure-time physical activity at 12 months
研究概览
简要总结
To verify changes in physical activity levels, metabolic markers, and physical fitness as results of two physical activity interventions within the Brazilian public health system (primary health care).
详细描述
The effects of two strategies - lifestyle counseling focused on physical activity, and supervised exercise - adapted to the Brazilian primary health care system and resources will be compared between them and with a control group. Subjects are healthy, physically inactive adults from a low socioeconomic area of Sao Paulo city. Evaluations will be done at the study baseline, 6 months, 12 months, and 18 months (6 months follow-up) after the beginning. The primary outcome is leisure-time physical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 否
入选标准
- •18 years old or more;
- •To be registered in the Brazilian public health system.
排除标准
- •Practice of leisure-time physical activity in the previous month;
- •Practice of transport-related physical activity (walking or cycling) for at least 150 minutes in the previous week;
- •Diagnostic of type II diabetes or severe arterial hypertension;
- •Use of beta-blockers for treating hypertension or cardiovascular disease;
- •Health problem or disease that would make the individual incapable of leaving home and making the journey to practice physical activity;
- •Diseases such as cancer, cirrhosis, chronic kidney disease, chronic obstructive pulmonary disease osteoporosis and severe depression at advanced stages;
- •Cognitive problem or disease that would not allow the individual from answering the questionnaire alone;
- •Being morbidly obese, with a body mass index (BMI) ≥40 kg/m2;
- •To have plans to move house over the two-year subsequent period;
- •Being pregnant.
结局指标
主要结局
Change from baseline leisure-time physical activity at 12 months
时间窗: 12 months
Change from baseline leisure-time physical activity at 18 months
时间窗: 18 months
次要结局
- Change from baseline leisure-time physical activity at 6 months(6 months)
- Change from baseline transport-related physical activity at 12 months(12 months)
- Change from baseline transport-related physical activity at 6 months(6 months)
- Change from baseline transport-related physical activity at 18 months(18 months)
- Change from baseline quality of life at 12 months(12 months)
- Change from baseline quality of life at 18 months(18 months)
- Change from baseline physical fitness at 12 months(12 months)
- Change from baseline physical fitness at 18 months(18 months)
- Change from baseline body composition at 12 months(12 months)
- Change from baseline body composition at 18 months(18 months)
- Change from baseline blood pressure at 12 months(12 months)
- Change from baseline blood pressure at 18 months(18 months)
- Change from baseline blood glucose at 12 months(12 months)
- Change from baseline blood glucose at 18 months(18 months)
- Change from baseline blood lipids at 12 months(12 months)
- Change from baseline blood lipids at 18 months(18 months)
研究者
Alex Antonio Florindo
Ph.D.
University of Sao Paulo