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Effects of a Low Glycemic Index in Obese Children

2014年1月28日 更新者：Chulalongkorn University

Effects of a Low Glycemic Index Diet on Body Composition and Metabolic Syndrome Risks in Obese Thai Children: A Randomized Controlled Trial

The objective of this study is to compare the effectiveness of a low-GI diet program and a standard counseling program in the treatment of obese Thai children.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat diet (control group). Both groups were followed-up every month for six months. The primary outcomes were body composition changes during the six-month period, measured by dual X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid profiles.

The adherence to the nutritional education and physical activity recommendation was evaluated by using three-day dietary records (two weekdays and one weekend day) and a physical activity questionnaire at each visit. All participants were examined and counseled about physical activity and life style modification strategies by a pediatrician at every visit.

研究类型

介入性

注册 (实际的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 泰国
    • Bangkok
      • Patumwan、Bangkok、泰国、10330
        • Chulalongkorn University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

9年 至 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Children aged between nine to sixteen years old
  • BMI higher than the International Obesity Task Force cut-off

Exclusion Criteria:

  • psychological problems
  • underlying diseases that might affect a weight management program
  • used drugs associated with weight increment or reduction
  • attended other weight management programs

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：low calorie/fat diet
The low calorie/fat diet group, obese children aged 9-16, received conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).
行为的：low calorie/fat diet
Conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).
实验性的：Low glycaemic index diet
Low glycaemic index diet group, obese children of both sexes aged 9-16, received experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).
行为的：Low glycaemic index diet
Experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change from baseline in body composition measured by BIA and DEXA at month 6
大体时间：6 months
6 months

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in metabolic syndrome risks at month 6
大体时间：6 months
Metabolic syndrome risks are fasting blood sugar, insulin and lipid profiles.
6 months

其他结果措施

结果测量
大体时间
Change from baseline in body weight, BMI z-score and waist circumference at month 6
大体时间：6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chulalongkorn University

调查人员

  • 首席研究员：Sirinuch Chomtho, M.D., PhD.、Chulalongkorn University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年1月1日

研究注册日期

首次提交

2014年1月28日

首先提交符合 QC 标准的

2014年1月28日

首次发布 (估计)

2014年1月30日

研究记录更新

最后更新发布 (估计)

2014年1月30日

上次提交的符合 QC 标准的更新

2014年1月28日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • LGI-01

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Ethiopia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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