Back to resultsTrial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
Primary Purpose
Overweight
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive weight management
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
Eligibility 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.
Sites / Locations
- Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Outcomes
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
Full Information
NCT ID
NCT00277420
First Posted
January 12, 2006
Last Updated
August 21, 2015
Sponsor
Medical College of Wisconsin
Collaborators
United Community Center, Milwaukee SCORES, Milwaukee Kickers Soccer Club
1. Study Identification
Unique Protocol Identification Number
NCT00277420
Brief Title
Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
Official Title
A Randomized Controlled Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI has left institution after losing funding for this PI-initiated study
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical College of Wisconsin
Collaborators
United Community Center, Milwaukee SCORES, Milwaukee Kickers Soccer Club
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive weight management
Primary Outcome Measure Information:
Title
change in body mass index (BMI) z-score
Secondary Outcome Measure Information:
Title
height, weight, and BMI
Title
percent body fat
Title
physical activity
Title
sedentary activity
Title
dietary habits
Title
the child's quality of life
Title
self-esteem
Title
physical fitness
Title
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)
Title
the parents' BMI
Title
the child's satisfaction with opportunities to lose weight and increase physical activity in the past year
Title
the parents' satisfaction with opportunities for the child to lose weight and increase physical activity in the past year
Title
costs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Flores, MD
Organizational Affiliation
Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jane Brotanek, MD
Organizational Affiliation
Assistant Professor of Pediatrics, Department of Pediatrics, Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julio C Maldonado, BA
Organizational Affiliation
Project Coordinator II, Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children
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