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A Randomized Controlled Trial Of A Culturally-Appropriate Weight Loss Intervention For Overweight Latino Children

Information provided by Medical College of Wisconsin
Information obtained from ClinicalTrials.gov on 2006-12-08
Link to the current ClinicalTrials.gov record.

Condition(s) treated: Overweight

Intervention: Comprehensive weight management (Behavior)

Enrollment status: Recruiting. Expecting to enroll 300 people.

Sponsor: Medical College of Wisconsin

Principal investigator(s) or official(s):
Glenn Flores, MD, Study Director, Affiliation: Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Jane Brotanek, MD, Principal Investigator, Affiliation: Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of Wisconsin
Julio C Maldonado, BA, Principal Investigator, Affiliation: Project Coordinator II, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin

Overall contact:
Julio C Maldonado, BA, Phone: 414-456-4159, Email: jmaldona@mcw.edu

Summary

This project aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. The intervention promotes lifestyle changes through a low glycemic index weight loss regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary counseling including cooking classes for parents. In addition to weight reduction for overweight Latino children, the project has the potential to reduce missed school days and improve self-esteem and quality of life.

Clinical Details

Official title: Glenn Flores, MD, FAAP (Pediatrics)

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in BMI z-score

Secondary outcome: height, weight, and BMI; percent body fat; physical activity; sedentary activity; dietary habits; the child’s quality of life; self esteem; physical fitness; selected health and use of health services measures (missed school days, parental missed work days, and number of healthcare provider visits for illness by child); the parents’ BMI; the child’s satisfaction with opportunities to lose weight and increase physical activity in the past year; the parents’ satisfaction with opportunities for the child to lose weight and increase physical activity in the past year; costs

Eligibility

Minimum eligible age: 6 Years. Maximum eligible age: 17 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:-

- Children must be of Latino descent

- At risk for overweight or overweight

- 6-17 years old.

Exclusion Criteria:

- Age > 17 years old

- Not overweight or at risk for overweight

- non-Latino ethnicity/race.

Locations and Contact Information

Julio C Maldonado, BA, Phone: 414-456-4159, Email: jmaldona@mcw.edu

Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States; Recruiting
Julio C Maldonado, BA, Phone: 414-456-4159, Email: jmaldona@mcw.edu
Glenn Flores, MD, Principal Investigator
Jane Brotanek, MD, Principal Investigator
Julio C Maldonado, BA, Principal Investigator
Additional Information

Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin

Start date: August 2005
End date: August 2008
Last updated: March 14, 2006

     
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