My Body is Fit and Fabulous: an Intervention Program to Combat Obesity Among Malaysian School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,438
- 主要终点
- BMI z-score
研究概览
简要总结
"My Body is Fit and Fabulous" (MyBFF@school) program was designed specifically for overweight and obese school children in order to help them control their BMI and body fat. MyBFF@school is a multi-faceted obesity intervention program that incorporated physical activity, nutrition and psychology modules.
详细描述
"My Body is Fit and Fabulous" (MyBFF@school) is a school-based, cluster randomised controlled trial (C-RCT) study that primarily aimed to evaluate the effectiveness of MyBFF@school program on overweight and obese school childrens' BMI for age (BMI z-score) and body fat percentage at 3 and 6 months post intervention. Primary and secondary schools in the central region of Peninsular Malaysia were randomised to either intervention or control school via systematic random sampling method. The selected intervention schools underwent MyBFF@school programme that consisted of physical activity, nutrition and psychology modules, whereas the control schools followed the standard national school curriculum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Give consent
- •Overweight and obese students with BMI for age (BMI z-score) more than +1SD based on WHO 2007 Growth Reference
- •Age between 9-16 years old
排除标准
- •BMI for age below and equal +1SD
- •Physical or mental disability
- •Medical conditions that prevent him/her to participate in moderate-to-vigorous physical activity
- •Co-morbidities that may interfere with the study such as:
- •diagnosed type 2 diabetes mellitus
- •hypertension
- •nephritic syndrome
- •congenital heart disease
- •skeletal anomalies
- •On steroids
- •On anti-epileptic
- •On methylphenidate
研究组 & 干预措施
Control
Age-matched overweight and obese students were selected from control schools. The students participated in their usual health and physical education classes plus any other curriculum activities provided by the school.
Intervention
Overweight and obese students were recruited from intervention schools. Students underwent MyBFF@school intervention programme that consisted of physical activity, nutrition and psychological modules for the duration of 6 months. MyBFF@school intervention programme were conducted by trained personnel that were stationed full-time at each intervention school.
干预措施: MyBFF@school (Other)
结局指标
主要结局
BMI z-score
时间窗: Change from Baseline BMI z-score at 3 months and change from Baseline BMI z-score at 6 months
To see changes in BMI z-score. Also called as BMI standard deviation scores, which measures relative weight adjusted for child age and sex. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2. By using the value of BMI obtained, BMI z-score was calculated using World Health Organization (WHO) AnthroPlus 2007 software, with indication of overweight \>+1.0 SD, obese \>+2.0 SD and morbidly obese \>+3.0 SD.
Percentage of Body Fat (%)
时间窗: Change from Baseline Body Fat Percentage at 3 months and change from Baseline Body Fat Percentage at 6 months
To see changes in percentage of body fat. It is the percentage of body weight that is made up of fat. It consists of both storage body fat and essential body fat. It was measured in light clothing without shoes and socks to the nearest 0.1 kg using a pre-calibrated body impedance analyser (InBody 770, Korea)
Waist Circumference (cm)
时间窗: Change from Baseline Waist Circumference at 3 months and change from Baseline Waist Circumference at 6 months
To see changes in Waist Circumference. Waist Circumference was measured twice to the nearest 0.1 cm over the skin midway between the tenth rib and the iliac crest at the end of normal expiration, using a non-extensible tape.
Skeletal Muscle Mass (kg)
时间窗: Change from Baseline Skeletal Muscle Mass at 3 months and change from Baseline Skeletal Muscle Mass at 6 months
To see changes in Skeletal Muscle Mass. Skeletal Muscle Mass is the weight of muscles that connected to the bones in the body that were measured in light clothing without shoes and socks to the nearest 0.1 kg using a pre-calibrated body impedance analyser (InBody 770, Korea)
次要结局
- HDL-C Level(Change from Baseline HDL-C Level at 6 months.)
- Fasting Insulin Level(Change from Baseline Fasting Insulin Level at 6 months.)
- Nutrition Knowledge(Change in Nutrition Knowledge from Baseline to 6 months assessment)
- Nutrition Attitude(Change in Nutrition Attitude from Baseline to 6 months assessment)
- LDL-C Level(Change from Baseline LDL-C Level at 6 months.)
- HbA1c Level(Change from Baseline HbA1c Level at 6 months.)
- Fasting Plasma Glucose(Change from Baseline Fasting Plasma Glucose at 6 months.)
- Physical Fitness Score(Change from Baseline Physical Fitness Score at 3 months and change from Baseline Physical Fitness Score at 6 months)
- Stages of Change for Fruit and Vegetable Intake (Secondary School)(Change from Baseline Stages of Change of Fruit and Vegetable Intake at 6 months)
- Emotional and Psychological Well-Being (Secondary School)(Change from Baseline Emotional and Psychological Well-Being at 6 months)
- Total Cholesterol(Change from Baseline Total Cholesterol at 6 months.)
- Triglycerides Level(Change from Baseline Triglycerides Level at 6 months.)
- HOMA-IR(Change from Baseline HOMA-IR at 6 months.)
- TG:HDL-C Ratio(Change from Baseline TG:HDL-C Ratio at 6 months.)
- Health-Related Quality of Life (Primary School)(Change in behaviour of fruit and vegetable intake from Baseline to 6 months assessment)
- Eating Attitude (Primary School)(Change from Baseline Eating Attitude at 6 months)
- Eating Attitude (Secondary School)(Change from Baseline Eating Attitude at 6 months)
- Nutrition Practice(Change in Nutrition Practice from Baseline to 6 months assessment)
- Stages of Change for Weight Management (Secondary School)(Change in behaviour of weight management from Baseline to 6 months assessment)
- Well-Being (Primary School)(Change from Baseline Well-Being at 6 months)
- Healthy Eating Behavior (Secondary School)(Change from Baseline Healthy Eating Behavior at 6 months)