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临床试验/NCT00149695
NCT00149695已完成不适用

Soft Drink, Milk and Obesity in Chilean Children

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
1
主要终点
Change in percent body fat by DXA scan

研究概览

简要总结

The primary aim of this randomized controlled trial is to evaluate the effects of replacing habitual consumption of sugar-sweetened soft drinks with milk over 16 weeks.

详细描述

The prevalence of obesity has risen dramatically among children in the U.S. and throughout the world since the 1960s. Many factors are thought to have contributed to the epidemic of pediatric obesity. One factor that has received increasing attention is consumption of sugar-sweetened beverages. Feeding studies suggest physiological mechanisms by which sugar in liquid form may be less satiating than other foods. An observational study found total energy consumption to be greater among children who consume sugar-sweetened beverages compared to non-consumes. Short-term interventional studies report increasing energy intake and body weight in subjects given sugar-sweetened beverages compared to non-caloric beverages. Our preliminary data found that the risk for becoming obese increased by about 60% in middle school children for every additional serving per day of sugar-sweetened beverage consumed. The purpose of the present study is to conduct a 16-week clinical trial involving 96 children ages 8 to 10 years in Chile, a developing nation characterized as undergoing a "nutrition transition." The subjects, selected for current sugar-sweetened soft drink consumption, will be randomly assigned to intervention or control groups. The intervention group will be encouraged to substitute milk products for soft-drinks; to facilitate this dietary change, a variety of milk products will be delivered to subjects' homes on a weekly basis. Clinical endpoints include changes in dietary quality, body weight, adiposity by DEXA-scan and measures of calcium homeostasis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single

入排标准

年龄范围
8 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Male or female, age 8 to 10 years
  • Tanner Stage I
  • BMI between 85th and 95th percentiles for age and gender
  • Consuming at least 2 servings/day of sugar-sweetened beverages
  • Willingness to consume milk instead of sugar-sweetened beverages for 16 weeks
  • Able to read Spanish and accurately complete dietary assessments

排除标准

  • Presence of a serious underlying medical condition
  • Taking any medication that affects body weight
  • History of lactose intolerance or milk protein allergies
  • History of an eating disorder

结局指标

主要结局

Change in percent body fat by DXA scan

次要结局

  • Body mass index
  • Blood glucose
  • Blood insulin
  • Serum lipids

研究者

申办方类型
Other

研究点 (1)

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Soft Drink, Milk and Obesity in Chilean Children | 临床试验