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Sponsors and Collaborators: |
John E. Fogarty International Center (FIC) Charles H. Hood Foundation |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00149695 |
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 | Intervention |
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Obesity |
Behavioral: Weekly home delivery of milk products |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Soft Drink, Milk and Obesity in Chilean Children |
Estimated Enrollment: | 96 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | December 2005 |
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.
Ages Eligible for Study: | 8 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Chile | |
INTA – University of Chile | |
Santiago, Chile |
Principal Investigator: | David S Ludwig, MD, PhD | Children's Hospital Boston |
Principal Investigator: | Cecilia Albala, MD | INTA – University of Chile |
Study Director: | Cara B Ebbeling, PhD | Children's Hospital Boston |
Study Director: | Mariana Cifuentes, PhD | INTA – University of Chile |
Study ID Numbers: | TW006818-Fogarty |
Study First Received: | August 31, 2005 |
Last Updated: | September 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00149695 |
Health Authority: | United States: Federal Government |
Obesity, beverages, weight loss, body mass index, diet |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overweight Overnutrition |