The Louisiana (LA) Health Project

• ClinicalTrials.gov Identifier: NCT00289315
• Recruitment Status: Completed
• First Posted: February 9, 2006
• Results First Posted: June 12, 2018
• Last Update Posted: July 10, 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)
• Information provided by (Responsible Party): Corby K. Martin, Pennington Biomedical Research Center

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.

Condition or disease	Intervention/treatment	Phase
Childhood Obesity	Behavioral: Primary (Environmental) Weight Gain Prevention; Behavioral: Secondary (Behavioral) Weight Gain Prevention; Behavioral: Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2060 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
• Study Start Date: August 2005
• Actual Primary Completion Date: May 2009
• Actual Study Completion Date: May 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; Primary (Environmental) Prevention of Weight Gain	Behavioral: Primary (Environmental) Weight Gain Prevention; School-based program that modifies the school environment to promote healthy eating and physical activity
Experimental: Arm 2; Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program	Behavioral: Primary (Environmental) Weight Gain Prevention; School-based program that modifies the school environment to promote healthy eating and physical activity; Behavioral: Secondary (Behavioral) Weight Gain Prevention; School-based environmental program to promote healthy eating and physical activity in the overweight students.
Experimental: Arm 3; Control - no Environmental or Behavioral Program intervention	Behavioral: Control; Control program that does not include an active intervention for promoting healthy eating and physical activity.

Outcome Measures

Primary Outcome Measures :

1. % Body Fat (Boys) [ Time Frame: Baseline and 3 years ]
   change in percent body fat between Baseline and 3 years for boys
2. BMI Z-score (Boys) [ Time Frame: Baseline and three years ]
   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
3. % Body Fat (Girls) [ Time Frame: Baseline and 3 years ]
   change in percent body fat between Baseline and 3 years for girls
4. BMI Z-score (Girls) [ Time Frame: Baseline and three years ]
   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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

-

Contacts and Locations

Locations

United States, Louisiana

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pennington Biomedical Research Center

United States Department of Agriculture (USDA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Corby K. Martin, Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00289315
• Other Study ID Numbers: LA Health; R01HD048483-01 ( U.S. NIH Grant/Contract )
• First Posted: February 9, 2006
• Results First Posted: June 12, 2018
• Last Update Posted: July 10, 2018
• Last Verified: June 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Pediatric Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight