NCT00365651

Brief Summary

This study will examine whether two months of youth soccer, combined with a single brief behavioral/nutritional intervention, can reduce BMI in 5th grade overweight or obese females.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 21, 2007

Status Verified

May 1, 2007

First QC Date

August 15, 2006

Last Update Submit

May 18, 2007

Conditions

ObesityOverweight

Keywords

obesityoverweight

Outcome Measures

Primary Outcomes (1)

  • BMI

    5 months

Secondary Outcomes (1)

  • My Tips for Families Quiz

    5 months

Interventions

Youth SoccerPROCEDURE

Eligibility Criteria

Age9 Years - 12 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • obese or overweight 4th grade public school student in Starkville

You may not qualify if:

  • unable to run or physical disease or disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leach Chiropractic Clinic, Inc.

Starkville, Mississippi, 39759, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert A Leach, DC, MS(c)

    Leach Chiropractic Clinic, Inc

    PRINCIPAL INVESTIGATOR

  • Joyce M Yates, Ed.D.

    Mississippi University for Women

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 17, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2006

Last Updated

May 21, 2007

Record last verified: 2007-05

Locations

US(1)