Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT00149695
Status:
COMPLETED
Last Update Posted:
2010-08-24
First Post:
2005-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soft Drink, Milk and Obesity in Chilean Children
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Soft Drink, Milk and Obesity in Chilean Children
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R03TW006818 | NIH | None | https://reporter.nih.gov/quic… | View |