Soft Drink, Milk and Obesity in Chilean Children
2010年8月20日 更新者:Boston Children's Hospital
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.
研究概览
详细说明
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.
研究类型
介入性
注册
96
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
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Santiago、智利
- INTA - University of Chile
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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
8年 至 10年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
研究衡量的是什么?
主要结果指标
结果测量 |
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Change in percent body fat by DXA scan
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次要结果测量
结果测量 |
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血糖
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体重指数
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Blood insulin
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Serum lipids
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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。
合作者
调查人员
- 研究主任:Cara B Ebbeling, PhD、Boston Children's Hospital
- 首席研究员:Cecilia Albala, MD、INTA - University of Chile
- 研究主任:Mariana Cifuentes, PhD、INTA - University of Chile
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. Lancet. 2001 Feb 17;357(9255):505-8. doi: 10.1016/S0140-6736(00)04041-1.
- Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. doi: 10.1001/jama.287.16.2081.
- Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.
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
2004年7月1日
研究完成 (实际的)
2005年12月1日
研究注册日期
首次提交
2005年8月31日
首先提交符合 QC 标准的
2005年9月6日
首次发布 (估计)
2005年9月8日
研究记录更新
最后更新发布 (估计)
2010年8月24日
上次提交的符合 QC 标准的更新
2010年8月20日
最后验证
2010年8月1日
更多信息
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.