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

This study has been withdrawn prior to enrollment.
(PI has left institution after losing funding for this PI-initiated study)
Sponsor:
Collaborators:
United Community Center
Milwaukee SCORES
Milwaukee Kickers Soccer Club
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00277420
First received: January 12, 2006
Last updated: August 21, 2015
Last verified: August 2015
  Purpose
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.

Condition Intervention
Overweight
Behavioral: Comprehensive weight management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • change in body mass index (BMI) z-score

Secondary Outcome Measures:
  • 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

Enrollment: 0
Study Start Date: August 2005
Estimated Study Completion Date: August 2008
  Eligibility

Ages Eligible for Study:   6 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00277420

Locations
United States, Wisconsin
Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
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
  More Information

ClinicalTrials.gov Identifier: NCT00277420     History of Changes
Other Study ID Numbers: #CHW 05/75, HRRC 214-05 
Study First Received: January 12, 2006
Last Updated: August 21, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on December 09, 2016