Soft Drink, Milk and Obesity in Chilean Children

Obesity Clinical Trial

Official title:

Soft Drink, Milk and Obesity in Chilean Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149695
• Other study ID #: TW006818-Fogarty (completed)
• Secondary ID: R03TW006818
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: August 20, 2010
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: August 2010
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Weekly home delivery of milk products

Locations

Country	Name	City	State
Chile	INTA - University of Chile	Santiago

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Boston	Charles H. Hood Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

Chile, 

References & Publications (2)

Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. Lancet. 2001 Feb 17;357(9255):505-8. — View Citation

Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percent body fat by DXA scan
Secondary	Body mass index
Secondary	Blood glucose
Secondary	Blood insulin
Secondary	Serum lipids