Evaluation of the Planet Nutrition Program on Obesity Parameters in Mexican Schoolchildren: Pilot Randomized ControlledTrial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in BMI z score
研究概览
简要总结
Obesity prevention programs in schools are essential to promoting healthy lifestyles. There are programs with positive effects on obesity parameters, but only a few of them have didactic material for its dissemination. In United States they have effective programs (with materials for their implementation) and some are already being implemented in different schools. In Mexico our study group has developed a program called "Planet Nutrition" that includes a manual.The main aim of this study is to evaluate the efficacy of the program "Planet Nutrition"-a nutrition education and behaviour change program- on BMI Z score in school children compared to a control group at 9 weeks. This pilot stud is a randomized controlled trial. The study will be conducted with 41 participants. The primary outcome was the change in the BMI Z score from baseline to 9 weeks. Secondary outcomes were the changes from baseline to 9 weeks in body fat percentage, waist circumference, systolic and diastolic blood pressure, consumption of healthy and unhealthy food, physical activity and sedentary lifestyle, cardiorespiratory capacity and nutrition knowledge. Additionally BMI Z score will be measured at 23 weeks, after the summer vacations. Considering evidence that this period could have a negative impact on children´s weight.
详细描述
Fifth grade students from a public elementary school in Hermosillo, Sonora, Mexico were invited to participate in the program. The nutritionist team of the study made the request face to face in the classrooms. A printed invitation was delivered to be given to schoolchildren parents, in addition to the informed consent and assent along with a data questionnaire. To be included children must be in fifth grade from the chosen school and be between 9 to 12 years old. The exclusion criteria were, having or develop a medical condition, taking medication or having an intervention that affects body weight, having a condition that prevents physical activity (cardiovascular, respiratory, muscular, osteoarticular, etc.) at baseline or during the study, and withdrawal of the consent informed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fifth grade students of the chosen school.
- •Having 9 to 12 years old.
排除标准
- •Having a condition, taking medication or carrying out an intervention that affects body weight.
- •Condition that impede physical activity including cardiovascular, respiratory, muscular and bone condition.
- •Withdrawal of informed consent and assent.
- •Development of a health problem or taking medication with effect on body weight during the study.
- •Participate in another intervention or treatment for obesity management during the study.
结局指标
主要结局
Change in BMI z score
时间窗: Baseline to 9 weeks
First, the weight and height of the children were measured with a SECA digital scale and a stadiometer (SECA 213). Then, the BMI z score was obtained using the WHO Anthro Plus software, where the values of weight, age, date of birth and sex were considered.
次要结局
- Change in the consumption of healthy and unhealthy food(Baseline to 9 weeks)
- Change in nutrition knowledge(Baseline to 9 weeks)
- Change in systolic and diastolic blood pressure(Baseline to 9 weeks)
- Change in auto-reported physical activity and sedentary activities(Baseline to 9 weeks)
- Change in body fat(Baseline to 9 weeks)
- Change in waist circumference(Baseline to 9 weeks)
- Change in cardiorespiratory capacity(Baseline to 9 weeks)
- Change in BMI Z score(9 weeks to 21 weeks)
研究者
Rolando Giovanni Díaz Zavala
Full time professor
Universidad de Sonora