NCT00454610

Brief Summary

The purpose of the study was to design a weight management program for Mexican American youth and to determine the effectiveness of the program for weight management compared to a self help program.

  1. 1.At the end of 6 months, individuals randomly assigned to Intensive Intervention (II) (instructor/trainer led intervention) will lose more weight than individuals assigned to Self Help (SH) only.
  2. 2.At the end of 1 year, individuals randomly assigned to II will maintain their weight losses better than individuals assigned to SH.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Status
completed

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

January 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

First QC Date

March 30, 2007

Last Update Submit

February 23, 2017

Conditions

Keywords

PediatricOverweightObesityInterventionPreventionMexican American

Outcome Measures

Primary Outcomes (1)

  • standardized body mass index (zbmi)

Secondary Outcomes (4)

  • blood levels,

  • changes in percent body fat,

  • overall psychological functioning

  • eating behaviors

Interventions

FLOWBEHAVIORAL
SelfHelpBEHAVIORAL

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrolled in the 6th or 7th grade at the target school.
  • Parent consent and child assent to participate.

You may not qualify if:

  • Taking medications for weight control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Tyler C, Johnston CA, Fullerton G, Foreyt JP. Reduced quality of life in very overweight Mexican American adolescents. J Adolesc Health. 2007 Apr;40(4):366-8. doi: 10.1016/j.jadohealth.2006.10.015. Epub 2007 Feb 5.

    PMID: 17367735BACKGROUND
  • Johnston CA, Tyler C, Fullerton G, Poston WS, Haddock CK, McFarlin B, Reeves RS, Foreyt JP. Results of an intensive school-based weight loss program with overweight Mexican American children. Int J Pediatr Obes. 2007;2(3):144-52. doi: 10.1080/17477160701305864.

  • Fullerton G, Tyler C, Johnston CA, Vincent JP, Harris GE, Foreyt JP. Quality of life in Mexican-American children following a weight management program. Obesity (Silver Spring). 2007 Nov;15(11):2553-6. doi: 10.1038/oby.2007.306.

  • Johnston CA, Palcic JL, Tyler C, Stansberry S, Reeves RS, Foreyt JP. Increasing vegetable intake in Mexican-American youth: a randomized controlled trial. J Am Diet Assoc. 2011 May;111(5):716-20. doi: 10.1016/j.jada.2011.02.006.

  • Johnston CA, Tyler C, Fullerton G, McFarlin BK, Poston WS, Haddock CK, Reeves RS, Foreyt JP. Effects of a school-based weight maintenance program for Mexican-American children: results at 2 years. Obesity (Silver Spring). 2010 Mar;18(3):542-7. doi: 10.1038/oby.2009.241. Epub 2009 Aug 6.

  • Johnston CA, Tyler C, McFarlin BK, Poston WS, Haddock CK, Reeves R, Foreyt JP. Weight loss in overweight Mexican American children: a randomized, controlled trial. Pediatrics. 2007 Dec;120(6):e1450-7. doi: 10.1542/peds.2006-3321.

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • John P Foreyt, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2007

First Posted

April 2, 2007

Study Start

January 1, 2005

Study Completion

March 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02