LA Health Project HIPTeens Project (a Secondary Prevention Program) and the Wise Mind Project (a Primary Prevention Program).
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Childhood Obesity |
Behavioral: Primary weight gain prevention Behavioral: Primary Prevention Behavioral: Primary and Secondary Prevention Other: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | LA Health Project HIPTeens Project (a Secondary Prevention Program) and the Wise Mind Project (a Primary Prevention Program). |
- prevention of weight gain [ Time Frame: three years ] [ Designated as safety issue: No ]
- body mass index z score [ Time Frame: three years ] [ Designated as safety issue: No ]
- eating disorders [ Time Frame: three years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | July 2010 |
| Arms | Assigned Interventions |
|---|---|
|
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.
Behavioral: Primary Prevention
School-based environmental program for promotion of 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
|
|
No Intervention: Arm 3
Control program that does not include a weight gain prevention program
|
Other: Control
Control program that does not include an active intervention for promoting healthy eating and physical activity.
|
Eligibility| Genders Eligible for Study: | Both |
| 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:
-
Contacts and Locations| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
| Principal Investigator: | Donald A Williamson, Ph.D. | Pennington Biomedical Research Center |
More Information
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Donald Allen Williamson, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT00289315 History of Changes |
| Other Study ID Numbers: | LA Health, PBRC25018 |
| Study First Received: | February 8, 2006 |
| Last Updated: | December 6, 2007 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013