The Louisiana (LA) Health Project

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2060 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1

Primary (Environmental) Prevention of Weight Gain

Group Type EXPERIMENTAL

Primary (Environmental) Weight Gain Prevention

Intervention Type BEHAVIORAL

School-based program that modifies the school environment to promote healthy eating and physical activity

Arm 2

Primary (Envrironmental) and Secondary (Behavioral) Weight Gain Prevention Program

Group Type EXPERIMENTAL

Primary (Environmental) Weight Gain Prevention

Intervention Type BEHAVIORAL

School-based program that modifies the school environment to promote healthy eating and physical activity

Secondary (Behavioral) Weight Gain Prevention

Intervention Type BEHAVIORAL

School-based environmental program to promote healthy eating and physical activity in the overweight students.

Arm 3

Control - no Environmental or Behavioral Program intervention

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Control program that does not include an active intervention for promoting healthy eating and physical activity.

Interventions

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Primary (Environmental) Weight Gain Prevention

School-based program that modifies the school environment to promote healthy eating and physical activity

Intervention Type BEHAVIORAL

Secondary (Behavioral) Weight Gain Prevention

School-based environmental program to promote healthy eating and physical activity in the overweight students.

Intervention Type BEHAVIORAL

Control

Control program that does not include an active intervention for promoting healthy eating and physical activity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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