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ClinicalTrials.gov Identifier: NCT00149695
: September 8, 2005
Last Update Posted
: August 24, 2010
Boston Children’s Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Condition or disease
Behavioral: Weekly home delivery of milk products
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.
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Ages Eligible for Study:
8 Years to 10 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Presence of a serious underlying medical condition
Taking any medication that affects body weight
History of lactose intolerance or milk protein allergies