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The Louisiana (LA) Health Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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

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.

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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

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.




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



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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289315


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

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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    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: July 10, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight