Anthropometric and Metabolic Changes Associated With a Low-volume Home-based Exercise Program
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 主要终点
- Change from baseline for weight at 4 and 8 months of follow-up
研究概览
简要总结
Objective: This study aimed to characterize the food intake and energy expenditure of school cooks and to evaluate the anthropometric and metabolic changes that occurred after a low-volume home-based exercise program.
Methods: A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007. The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The nutritional intervention was focused on decreasing the amount of sugar used in school meals by the cooks as well as decreasing their own sugar intake. The exercise program consisted of stretching and aerobic exercises that could be practiced at home, at least three times per week (40 minutes per session), with a low-to-moderate intensity.
详细描述
A randomized clinical trial in the city of Niteroi, Rio de Janeiro, Brazil, was conducted during the school year of 2007 (March to December 2007). The trial had a factorial design based on two different interventions: 1) nutritional counseling and 2) home-based exercise. The present study focused on the effects of exercise intervention.
Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles. Because of the small number of male cooks (n=5), we included only women who were neither pregnant nor breastfeeding. Cooks on sick leave or those working in other capacities were excluded. A total of 101 cooks were eligible, and six refused to participate in the study.
All participants received information about the goals of the study and signed a document indicating informed consent. The study was approved by the institutional review board of the State University of Rio de Janeiro.
School cooks enrolled in the present study were public servants and work in periods of eight hours, five days per week, in three different shifts (morning, afternoon and night). They are responsible to prepare all meals served at school and cleaning up, and schools do not have any machine to help them to perform their tasks. They eat at least one meal at school.
Sample size As previously reported13), the sample size was calculated assuming an individual reduction of 10% in sugar consumption (3.4 grams) with a power of 80% and a 5% significance level. Anticipating a rate of participation agreement around 80%, the total sample size was estimated to be 80 school cooks. For this purpose, 20 schools employing a total of 130 school cooks were randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Of the 36 public schools spread over five different areas, we selected 20 schools from three areas with similar demographic and socio-economic profiles.
排除标准
- •School cooks who were pregnant or breastfeeding
结局指标
主要结局
Change from baseline for weight at 4 and 8 months of follow-up
时间窗: Baseline, 4 and 8 months
Body weight was measured using the same calibrated digital scale (Tanita, BC 533 Inner Scan) for all participants
次要结局
未报告次要终点
研究者
Mauro Felippe Felix Mediano
Principal Investigator
Rio de Janeiro State University
