Soft Drink, Milk and Obesity in Chilean Children

Study Overview
=================
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.

Official Title
-----------------
Soft Drink, Milk and Obesity in Chilean Children

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Weekly home delivery of milk products


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Weekly home delivery of milk products|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent body fat by DXA scan |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index |  |  | 
| Blood glucose |  |  | 
| Blood insulin |  |  | 
| Serum lipids |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, beverages, weight loss, body mass index, diet