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Soft Drink, Milk and Obesity in Chilean Children

This study has been completed.
Sponsor:
Collaborators:
Charles H. Hood Foundation
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00149695
First received: August 31, 2005
Last updated: August 20, 2010
Last verified: August 2010

August 31, 2005
August 20, 2010
July 2004
Not Provided
Change in percent body fat by DXA scan
Same as current
Complete list of historical versions of study NCT00149695 on ClinicalTrials.gov Archive Site
  • Body mass index
  • Blood glucose
  • Blood insulin
  • Serum lipids
Same as current
Not Provided
Not Provided
 
Soft Drink, Milk and Obesity in Chilean Children
Soft Drink, Milk and Obesity in Chilean Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Obesity
Behavioral: Weekly home delivery of milk products
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
December 2005
Not Provided

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
Both
8 Years to 10 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00149695
TW006818-Fogarty (completed), R03TW006818
Not Provided
Not Provided
Children's Hospital Boston
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Charles H. Hood Foundation
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
Children's Hospital Boston
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP