Soft Drink, Milk and Obesity in Chilean Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149695
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : August 24, 2010
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Information provided by:
Boston Children’s Hospital

Brief Summary:
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 Intervention/treatment Phase
Obesity Behavioral: Weekly home delivery of milk products Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Soft Drink, Milk and Obesity in Chilean Children
Study Start Date : July 2004
Actual Study Completion Date : December 2005

Primary Outcome Measures :
  1. Change in percent body fat by DXA scan

Secondary Outcome Measures :
  1. Body mass index
  2. Blood glucose
  3. Blood insulin
  4. Serum lipids

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149695

INTA - University of Chile
Santiago, Chile
Sponsors and Collaborators
Boston Children’s Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Charles H. Hood Foundation
Principal Investigator: David S Ludwig, MD, PhD Boston Children’s Hospital
Principal Investigator: Cecilia Albala, MD INTA - University of Chile
Study Director: Cara B Ebbeling, PhD Boston Children’s Hospital
Study Director: Mariana Cifuentes, PhD INTA - University of Chile

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00149695     History of Changes
Other Study ID Numbers: TW006818-Fogarty (completed)
R03TW006818 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

Keywords provided by Boston Children’s Hospital:
Obesity, beverages, weight loss, body mass index, diet

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms