Soft Drink, Milk and Obesity in Chilean Children

NCT00149695 | Completed

• 2 other identifiers: TW006818-Fogarty (completed)R03TW006818
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity, beverages, weight loss, body mass index, diet

Outcome Measures

Primary Outcomes (1)

• Change in percent body fat by DXA scan

Secondary Outcomes (4)

• Body mass index

• Blood glucose

• Blood insulin

• Serum lipids

Interventions

Weekly home delivery of milk products BEHAVIORAL

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Charles H. Hood Foundation: collaborator

Study Sites (1)

INTA - University of Chile

Santiago, Chile

Location

Related Publications (3)

• 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. doi: 10.1016/S0140-6736(00)04041-1.

  PMID: 11229668 BACKGROUND

• 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. doi: 10.1001/jama.287.16.2081.

  PMID: 11966382 BACKGROUND

• Albala C, Ebbeling CB, Cifuentes M, Lera L, Bustos N, Ludwig DS. Effects of replacing the habitual consumption of sugar-sweetened beverages with milk in Chilean children. Am J Clin Nutr. 2008 Sep;88(3):605-11. doi: 10.1093/ajcn/88.3.605.

  PMID: 18779274 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• David S Ludwig, MD, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Cecilia Albala, MD

  INTA - University of Chile

  PRINCIPAL INVESTIGATOR

• Cara B Ebbeling, PhD

  Boston Children's Hospital

  STUDY DIRECTOR

• Mariana Cifuentes, PhD

  INTA - University of Chile

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 8, 2005
• Study Start: July 1, 2004
• Study Completion: December 1, 2005
• Last Updated: August 24, 2010

Record last verified: 2010-08

Locations

CL (1)