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临床试验/NCT03429699
NCT03429699已完成不适用

Effectiveness of a Stage-based Lifestyle Modification Intervention for Obese Children

Universiti Putra Malaysia0 个研究点目标入组 50 人开始时间: 2012年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
BMI-for-age Z score

研究概览

简要总结

Interventions that encompass behavioral modifications of dietary intake and physical activity dietary management are essential for the management of obese children. This study assessed the effectiveness of a stage-based lifestyle modification intervention for obese children. A total of 50 obese children (7-11 years) were randomized to intervention (n=25) or control (n=25) group. Data were collected at baseline, at follow-up (every month) and at six-month post-intervention. The intervention group (IG) received stage-based lifestyle modification intervention based on Nutrition Practice Guideline for the Management of Childhood Obesity, while the control group (CG) received standard treatment. Changes in body composition, physical activity, and dietary intake were examined in both intervention and control groups.

详细描述

Main Objective:

To evaluate the effectiveness of Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity

Specific objectives:

To compare changes in body composition, energy and nutrient intake, as well as physical activity between children receiving the Stage-based Lifestyle Modification Intervention (i.e. intervention group) and the standard treatment (i.e. control group) for the management of childhood obesity.

Study hypothesis:

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The participants will be included if they are:
  • Children aged 2 - 12 years old
  • Obese based on the WHO growth chart 2007 (BMI-for-age more than +2SD)

排除标准

  • The participants will be excluded if they are:
  • Diagnosed with diabetes mellitus, psychiatric disorder (e.g. schizophrenia, severe autism or
  • mental retardation or psychosis), or other serious medical conditions.
  • Receiving medications that would potentially promote weight gain or weight loss.
  • Involved in any weight management program
  • Overweight, normal weight and underweight

研究组 & 干预措施

Intervention group

Experimental

干预措施: Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity (Behavioral)

Control group

Other

干预措施: Existing practice for the management of childhood obesity (Behavioral)

结局指标

主要结局

BMI-for-age Z score

时间窗: 24 weeks

weight (kg)

时间窗: 24 weeks

Height (cm)

时间窗: 24 weeks

次要结局

  • Fat (g)(24 weeks)
  • Fiber (g)(24 weeks)
  • waist circumference (cm)(24 weeks)
  • Mid-upper Arm Muscle Circumference (cm)(24 weeks)
  • carbohydrate (g)(24 weeks)
  • Body fat (%)(24 weeks)
  • Protein (g)(24 weeks)
  • Sugar (g)(24 weeks)
  • Physical Activity Questionnaire for Older Children (PAQ-C)(24 weeks)
  • Energy (kcal)(24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nor Baizura Md. Yusop

Senior Lecturer

Universiti Putra Malaysia

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