Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children - Tabular View

Tracking Information

First Received Date ^ICMJE

January 12, 2006

Last Updated Date

November 19, 2007

Start Date ^ICMJE

August 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

change in body mass index (BMI) z-score

Original Primary Outcome Measures ^ICMJE

Change in BMI z-score

Change History

Complete list of historical versions of study NCT00277420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

1) height, weight, and BMI
2) percent body fat
3) physical activity
4) sedentary activity
5) dietary habits
6) the child’s quality of life
7) self esteem
8) physical fitness
9) 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)
10) the parents’ BMI
11) the child’s satisfaction with opportunities to lose weight and increase physical activity in the past year
12) the parents’ satisfaction with opportunities for the child to lose weight and increase physical activity in the past year
13) costs

Descriptive Information

Brief Title ^ICMJE

Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children

Official Title ^ICMJE

A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children

Brief 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 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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Overweight

Intervention ^ICMJE

Behavioral: Comprehensive weight management

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

August 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children must be of Latino descent
At risk for becoming overweight or is overweight
6-17 years old.

Exclusion Criteria:

Age > 17 years old
Not overweight or at risk for becoming overweight
Non-Latino ethnicity/race.

Gender

Both

Ages

6 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Julio C Maldonado, BA

414-456-4159

jmaldona@mcw.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00277420

Responsible Party

Study ID Numbers ^ICMJE

#CHW 05/75, HRRC 214-05

Study Sponsor ^ICMJE

Medical College of Wisconsin

Collaborators ^ICMJE

United Community Center
Milwaukee SCORES
Milwaukee Kickers Soccer Club

Investigators ^ICMJE

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

Information Provided By

Medical College of Wisconsin

Verification Date

April 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP