Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 216
- 试验地点
- 4
- 主要终点
- To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program
研究概览
简要总结
The purpose of this study, and its original contribution to research, is to determine the impact of a physical activity skill development and parent centered family weight management program on the weight, cardiovascular health, physical activity, dietary intake and sedentary behaviors of overweight and obese children.
详细描述
AIMS
The aim of this randomized controlled trial (RCT) is to evaluate and compare in overweight children the effectiveness of the following interventions:
- a parent-centered dietary modification program; 2. a physical activity skill development program; and 3. a parent-centered dietary modification + physical activity skill development program.
BACKGROUND
We have successfully piloted two community-based conventional weight management programs, SHARK (a physical activity-based program) and PRAISE (a dietary modification program), suitable for use with overweight, pre-adolescent children, and propose that the combination of these two programs into a multi-component intervention has the potential to effectively treat child obesity. We hypothesize that at 6-, 12-, and 24-month follow-ups, compared to overweight children allocated to the physical activity only and dietary modification only groups, overweight children in the physical activity + dietary modification group will display a greater reduction in their adiposity and display improved metabolic profiles. Secondary analyses will determine if the combined intervention improves physical activity, sedentariness, energy intake, movement skills, self-esteem, and an activity of daily living.
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
- None
入排标准
- 年龄范围
- 66 Months 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight and obese children with the Wollongong and Newcastle regions, aged between 5.5 and 9
- •BMI within specified range
- •Otherwise healthy children
- •Not on any medications that may influence obesity
- •One parent able to attend all required sessions
- •Pre-pubertal
- •No sibling enrolled
排除标准
- •Children with BMI outside the specified range
- •Children on medication that may influence obesity
- •Children that have conditions that may influence obesity
结局指标
主要结局
To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program
a physical activity skill development program
and a parent-centered dietary modification + physical activity skill development program.
次要结局
未报告次要终点