LA Health Project HIPTeens Project (a Secondary Prevention Program) and the Wise Mind Project (a Primary Prevention Program).

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. Identifier: NCT00289315
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : June 12, 2017
United States Department of Agriculture (USDA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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. 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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: Primary weight gain prevention Behavioral: Primary Prevention Behavioral: Primary and Secondary Prevention Behavioral: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2709 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 Prevention of weight gain
Behavioral: Primary weight gain prevention
School-based program that modifies the school environment to promote healthy eating and physical activity
Behavioral: Primary Prevention
School-based environmental program to promote healthy eating and physical activity.
Experimental: Arm 2
Primary and secondary weight gain prevention program
Behavioral: Primary and Secondary Prevention
School-based program that combines an environmental weight gain prevention program with a curriculum/internet-based program to promote weight loss in overweight students
Experimental: Arm 3
Behavioral: Control
Control program that does not include an active intervention for promoting healthy eating and physical activity.

Primary Outcome Measures :
  1. Body Mass Index percentile [ Time Frame: three years ]
  2. Body Mass Index z score [ Time Frame: three years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 identifier (NCT number): NCT00289315

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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

Responsible Party: Corby K. Martin, Associate Professor, Pennington Biomedical Research Center Identifier: NCT00289315     History of Changes
Other Study ID Numbers: LA Health
R01HD048483-01A2 ( U.S. NIH Grant/Contract )
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms