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
  Purpose

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
Obesity
Behavioral: Weekly home delivery of milk products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Soft Drink, Milk and Obesity in Chilean Children

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

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

Secondary Outcome Measures:
  • Body mass index
  • Blood glucose
  • Blood insulin
  • Serum lipids

Estimated Enrollment: 96
Study Start Date: July 2004
Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   8 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149695

Locations
Chile
INTA - University of Chile
Santiago, Chile
Sponsors and Collaborators
Children's Hospital Boston
Charles H. Hood Foundation
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00149695     History of Changes
Other Study ID Numbers: TW006818-Fogarty (completed), R03TW006818
Study First Received: August 31, 2005
Last Updated: August 20, 2010
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 14, 2014