NCT00289315

Brief Summary

There is a worldwide pandemic of obesity with far-reaching consequences for the health of our nation. Obesity is the second leading cause of preventable death in the United States. Prevention of obesity, especially in children, has been deemed by public health policy makers to be one of the most important objectives for our country.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,060

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

June 12, 2018

Completed
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

3.8 years

First QC Date

February 8, 2006

Results QC Date

July 12, 2017

Last Update Submit

June 12, 2018

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (4)

  • % Body Fat (Boys)

    change in percent body fat between Baseline and 3 years for boys

    Baseline and 3 years

  • BMI Z-score (Boys)

    Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean

    Baseline and three years

  • % Body Fat (Girls)

    change in percent body fat between Baseline and 3 years for girls

    Baseline and 3 years

  • BMI Z-score (Girls)

    Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean

    Baseline and three years

Study Arms (3)

Arm 1

EXPERIMENTAL

Primary (Environmental) Prevention of Weight Gain

Behavioral: Primary (Environmental) Weight Gain Prevention

Arm 2

EXPERIMENTAL

Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program

Behavioral: Primary (Environmental) Weight Gain PreventionBehavioral: Secondary (Behavioral) Weight Gain Prevention

Arm 3

EXPERIMENTAL

Control - no Environmental or Behavioral Program intervention

Behavioral: Control

Interventions

Primary (Environmental) Weight Gain PreventionBEHAVIORAL

School-based program that modifies the school environment to promote healthy eating and physical activity

Arm 1Arm 2
Secondary (Behavioral) Weight Gain PreventionBEHAVIORAL

School-based environmental program to promote healthy eating and physical activity in the overweight students.

Arm 2
ControlBEHAVIORAL

Control program that does not include an active intervention for promoting healthy eating and physical activity.

Arm 3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Being one of the LA GEAR UP middle schools or a feeder elementary school
  • Having an enrollment of at least 100 students per school
  • All students in grades 4-6 of participating schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (9)

  • Williamson DA, Han H, Johnson WD, Martin CK, Newton RL Jr. Modification of the school cafeteria environment can impact childhood nutrition. Results from the Wise Mind and LA Health studies. Appetite. 2013 Feb;61(1):77-84. doi: 10.1016/j.appet.2012.11.002. Epub 2012 Nov 12.

    PMID: 23154216DERIVED

  • Williamson DA, Champagne CM, Harsha DW, Han H, Martin CK, Newton RL Jr, Sothern MS, Stewart TM, Webber LS, Ryan DH. Effect of an environmental school-based obesity prevention program on changes in body fat and body weight: a randomized trial. Obesity (Silver Spring). 2012 Aug;20(8):1653-61. doi: 10.1038/oby.2012.60. Epub 2012 Mar 8.

    PMID: 22402733DERIVED

  • Newton RL, Thomson JL, Rau KK, Ragusa SA, Sample AD, Singleton NN, Anton SD, Webber LS, Williamson DA. Psychometric characteristics of process evaluation measures for a rural school-based childhood obesity prevention study: Louisiana Health. Am J Health Promot. 2011 Jul-Aug;25(6):417-21. doi: 10.4278/ajhp.090914-ARB-297.

    PMID: 21721969DERIVED

  • Newton RL, Han H, Sothern M, Martin CK, Webber LS, Williamson DA. Accelerometry measured ethnic differences in activity in rural adolescents. J Phys Act Health. 2011 Feb;8(2):287-95. doi: 10.1123/jpah.8.2.287.

    PMID: 21415456DERIVED

  • Williamson DA, Han H, Johnson WD, Stewart TM, Harsha DW. Longitudinal study of body weight changes in children: who is gaining and who is losing weight. Obesity (Silver Spring). 2011 Mar;19(3):667-70. doi: 10.1038/oby.2010.221. Epub 2010 Sep 30.

    PMID: 20885393DERIVED

  • Martin CK, Thomson JL, LeBlanc MM, Stewart TM, Newton RL Jr, Han H, Sample A, Champagne CM, Williamson DA. Children in school cafeterias select foods containing more saturated fat and energy than the Institute of Medicine recommendations. J Nutr. 2010 Sep;140(9):1653-60. doi: 10.3945/jn.109.119131. Epub 2010 Jul 28.

    PMID: 20668251DERIVED

  • Gabriele JM, Stewart TM, Sample A, Davis AB, Allen R, Martin CK, Newton RL Jr, Williamson DA. Development of an internet-based obesity prevention program for children. J Diabetes Sci Technol. 2010 May 1;4(3):723-32. doi: 10.1177/193229681000400328.

    PMID: 20513340DERIVED

  • Williamson DA, Champagne CM, Han H, Harsha D, Martin CK, Newton RL, Ryan DH, Sothern MS, Stewart TM, Webber LS. Increased obesity in children living in rural communities of Louisiana. Int J Pediatr Obes. 2009;4(3):160-5. doi: 10.1080/17477160802596148.

    PMID: 19089707DERIVED

  • Williamson DA, Champagne CM, Harsha D, Han H, Martin CK, Newton R Jr, Stewart TM, Ryan DH. Louisiana (LA) Health: design and methods for a childhood obesity prevention program in rural schools. Contemp Clin Trials. 2008 Sep;29(5):783-95. doi: 10.1016/j.cct.2008.03.004. Epub 2008 Mar 26.

    PMID: 18448393DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Environment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Results Point of Contact

Title
Lori Steib
Organization
Pennington Biomedical Research Center
Lori.Steib@pbrc.edu
(225) 252-5030

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2006

First Posted

February 9, 2006

Study Start

August 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

July 10, 2018

Results First Posted

June 12, 2018

Record last verified: 2018-06

Locations

US(1)