Evaluation of a Stage-Based Tailored, Nutrition Education Package for Childhood Obesity (ST-NEPCO) (7-12 Years Old)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- BMI-for-age z -score change
研究概览
简要总结
A randomized controlled trial will be used to determine the effectiveness of ST-NEPCO. The study will involve obese children aged 7 to 11 years old. Participants will be assigned randomly to either the intervention or control group. The intervention group will receive counselling from the researcher based on ST-NEPCO, meanwhile the control group will receive counseling from dietitians based on the routine care for the management of childhood obesity. The study will be conducted for duration of 24 weeks. The individual counseling session will be held once a month for each participant during the weekend.
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
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7 to 11 years old
- •Children classified as obese (>+2SD) based on BMI-for-age for 5 to 19 years old (WHO, 2007).
排除标准
- •Children diagnosed with chronic asthma, diabetes mellitus, psychiatric disorders (e.g. schizophrenia, severe autism or mental retardation, or psychosis), or other serious medical conditions.
- •Children receiving medications that can potentially promote weight gain or weight loss.
- •Children participating in any weight management program
结局指标
主要结局
BMI-for-age z -score change
时间窗: Change from baseline to week 24
BMI-for-age z-score will be calculated using the WHO AnthroPlus software (http://www.who.int/growthref/tools/en) and the WHO 2007 growth reference will be used to determine the BMI-for-age z-score of participants (de Onis et al., 2007).
次要结局
- Energy and nutrient intakes [macronutrients, Saturated Fatty Acids (SFA), sugar and dietary fibre] change(Change from baseline to week 24)
- Body composition (BMI, Lean Body Mass (LBM), Body Fat Mass (BFM) change(Change from baseline to week 24)
- Waist and hip circumferences change(Change from baseline to week 24)
- Stage of readiness to lose weight change(Change from baseline to week 24)
- Physical activity score change(Change from baseline to week 24)
研究者
Nor Baizura Md. Yusop
Dr
Universiti Putra Malaysia