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

August 21, 2015 updated by: Medical College of Wisconsin

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in body mass index (BMI) z-score

Secondary Outcome Measures

Outcome Measure
self-esteem
physical activity
height, weight, and BMI
percent body fat
sedentary activity
dietary habits
the child's quality of life
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

United Community Center
Milwaukee SCORES
Milwaukee Kickers Soccer Club

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Anticipated)

August 1, 2008

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #CHW 05/75, HRRC 214-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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