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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00277420
Other study ID # #CHW 05/75, HRRC 214-05
Secondary ID
Status Withdrawn
Phase N/A
First received January 12, 2006
Last updated August 21, 2015
Start date August 2005
Est. completion date August 2008

Study information

Verified date August 2015
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Comprehensive weight management


Locations

Country Name City State
United States Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin Milwaukee Wisconsin

Sponsors (4)

Lead Sponsor Collaborator
Medical College of Wisconsin Milwaukee Kickers Soccer Club, Milwaukee SCORES, United Community Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in body mass index (BMI) z-score
Secondary height, weight, and BMI
Secondary percent body fat
Secondary physical activity
Secondary sedentary activity
Secondary dietary habits
Secondary the child's quality of life
Secondary self-esteem
Secondary physical fitness
Secondary 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)
Secondary the parents' BMI
Secondary the child's satisfaction with opportunities to lose weight and increase physical activity in the past year
Secondary the parents' satisfaction with opportunities for the child to lose weight and increase physical activity in the past year
Secondary costs
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