NCT00277420

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 16, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

First QC Date

January 12, 2006

Last Update Submit

August 21, 2015

Conditions

Overweight

Outcome Measures

Primary Outcomes (1)

  • change in body mass index (BMI) z-score

Secondary Outcomes (13)

  • height, weight, and BMI

  • percent body fat

  • physical activity

  • sedentary activity

  • dietary habits

  • +8 more secondary outcomes

Interventions

Comprehensive weight managementBEHAVIORAL

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Glenn Flores, MD

    Center for Advancement of Underserved Children (CAUC), Department of Pediatrics, Medical College of Wisconsin

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 16, 2006

Study Start

August 1, 2005

Study Completion

August 1, 2008

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

US(1)