The Louisiana (LA) Health Project

Study Overview
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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.

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.

Official Title
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LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Primary (Environmental) Weight Gain Prevention
* Behavioral: Secondary (Behavioral) Weight Gain Prevention
* Behavioral: Control


Participation Criteria
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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 Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Body Fat (Boys) | change in percent body fat between Baseline and 3 years for boys | Baseline and 3 years | 
| BMI Z-score (Boys) | 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 | Baseline and three years | 
| % Body Fat (Girls) | change in percent body fat between Baseline and 3 years for girls | Baseline and 3 years | 
| BMI Z-score (Girls) | 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 | Baseline and three years |