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临床试验/NCT02049788
NCT02049788已完成不适用

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

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年1月1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
70
试验地点
1
主要终点
Change from baseline in body composition measured by BIA and DEXA at month 6

研究概览

简要总结

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.

详细描述

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
9 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

low calorie/fat diet

Active Comparator

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).

干预措施: low calorie/fat diet (Behavioral)

Low glycaemic index diet

Experimental

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).

干预措施: Low glycaemic index diet (Behavioral)

结局指标

主要结局

Change from baseline in body composition measured by BIA and DEXA at month 6

时间窗: 6 months

次要结局

  • Change from baseline in metabolic syndrome risks at month 6(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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