The Louisiana (LA) Health Project
Primary Purpose
Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary (Environmental) Weight Gain Prevention
Secondary (Behavioral) Weight Gain Prevention
Control
Sponsored by
About this trial
This is an interventional prevention trial for Childhood Obesity
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: -
Sites / Locations
- Pennington Biomedical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Primary (Environmental) Prevention of Weight Gain
Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program
Control - no Environmental or Behavioral Program intervention
Outcomes
Primary Outcome Measures
% Body Fat (Boys)
change in percent body fat between Baseline and 3 years for boys
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
% Body Fat (Girls)
change in percent body fat between Baseline and 3 years for girls
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00289315
First Posted
February 8, 2006
Last Updated
June 12, 2018
Sponsor
Pennington Biomedical Research Center
Collaborators
United States Department of Agriculture (USDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00289315
Brief Title
The Louisiana (LA) Health Project
Official Title
LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
United States Department of Agriculture (USDA), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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. Obesity disproportionately affects citizens of minority and low socioeconomic status. A consensus of opinion has formed that the recently observed increased prevalence of obesity is caused by environmental and behavioral factors that favor easy access to high calorie foods and sedentary behavior. This prevention project, called LA Health, will test whether modification of these environmental and behavioral factors can prevent inappropriate weight gain in children who are enrolled in the fourth to sixth grades during Year 1. The primary aims of the LA Health project are to test the efficacy of two school-based approaches for obesity prevention. The two approaches are derived from two NIH-funded pilot studies called the HIPTeens project (a secondary prevention program) and the Wise Mind project (a primary prevention program). The study will test the efficacy of primary prevention alone and a combination of primary and secondary prevention in comparison to a no-treatment control group using a cluster randomization research design, with 18 school clusters from 9 different parishes randomly assigned to the three treatment arms. The following parishes were selected for the project: East Carroll, Madison, Franklin, East Feliciana, St. John, St. Helena, Pointe Coupee, Avoyelles, and Sabine Parishes. Thus far East Carroll, East Feliciana, St. John, Pointe Coupee, and Avoyelles Parishes have agreed to participate. We anticipate adding additional parishes in the second year of the project.The project will collaborate with a USDE funded project, LA GEAR UP, to test the relative efficacy obesity prevention programs for children who come from economically disadvantaged environments. The LA GEAR UP program is designed to enhance educational achievement. Since LA GEAR UP will be implemented in all 18 school clusters, all of the preventions intervention arms, including no-treatment, will be combined with an academic enhancement program. The study will span three years and will provide critical tests of strategies that modify the child's environment as a primary prevention strategy and provide health behavior modification via classroom instruction and internet counseling as a secondary prevention strategy. The study will also recruit a similar (but smaller) sample of students to measure changes in body weight relative to height, gender, and age over the same three-year period. This observation only control group will be studied to evaluate secular trends in changes in body weight so that body weight changes observed in the randomized trial can be interpreted within the context of stable versus unstable population changes in body weight. The results of this investigation will significantly impact public health policy related to obesity prevention in rural communities, minority communities, and in children from families that are economically disadvantaged.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2060 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Primary (Environmental) Prevention of Weight Gain
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Control - no Environmental or Behavioral Program intervention
Intervention Type
Behavioral
Intervention Name(s)
Primary (Environmental) Weight Gain Prevention
Intervention Description
School-based program that modifies the school environment to promote healthy eating and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Secondary (Behavioral) Weight Gain Prevention
Intervention Description
School-based environmental program to promote healthy eating and physical activity in the overweight students.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Control program that does not include an active intervention for promoting healthy eating and physical activity.
Primary Outcome Measure Information:
Title
% Body Fat (Boys)
Description
change in percent body fat between Baseline and 3 years for boys
Time Frame
Baseline and 3 years
Title
BMI Z-score (Boys)
Description
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
Time Frame
Baseline and three years
Title
% Body Fat (Girls)
Description
change in percent body fat between Baseline and 3 years for girls
Time Frame
Baseline and 3 years
Title
BMI Z-score (Girls)
Description
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
Time Frame
Baseline and three years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
-
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23154216
Citation
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.
Results Reference
derived
PubMed Identifier
22402733
Citation
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.
Results Reference
derived
PubMed Identifier
21721969
Citation
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.
Results Reference
derived
PubMed Identifier
21415456
Citation
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.
Results Reference
derived
PubMed Identifier
20885393
Citation
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.
Results Reference
derived
PubMed Identifier
20668251
Citation
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.
Results Reference
derived
PubMed Identifier
20513340
Citation
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.
Results Reference
derived
PubMed Identifier
19089707
Citation
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.
Results Reference
derived
PubMed Identifier
18448393
Citation
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.
Results Reference
derived
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The Louisiana (LA) Health Project
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