Childhood Obesity
Conditions
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.
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.
Interventions
School-based program that modifies the school environment to promote healthy eating and physical activity
School-based environmental program to promote healthy eating and physical activity in the overweight students.
Control program that does not include an active intervention for promoting healthy eating and physical activity.
Sponsors
Study design
Eligibility
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Body Fat (Boys) | Baseline and 3 years | change in percent body fat between Baseline and 3 years for boys |
| BMI Z-score (Boys) | 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 |
| % Body Fat (Girls) | Baseline and 3 years | change in percent body fat between Baseline and 3 years for girls |
| BMI Z-score (Girls) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Primary Prevention of weight gain
Primary weight gain prevention: School-based program that modifies the school environment to promote healthy eating and physical activity
Primary Prevention: School-based environmental program to promote healthy eating and physical activity. | 704 |
| Arm 2 Primary and secondary weight gain prevention program
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 | 725 |
| Arm 3 Control
Control: Control program that does not include an active intervention for promoting healthy eating and physical activity. | 586 |
| Total | 2,015 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Arm 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 10.5 years STANDARD_DEVIATION 1.2 | 10.5 years STANDARD_DEVIATION 1.2 | 10.6 years STANDARD_DEVIATION 1.2 | 10.5 years STANDARD_DEVIATION 1.2 |
| Sex: Female, Male Female | 412 Participants | 413 Participants | 351 Participants | 1176 Participants |
| Sex: Female, Male Male | 292 Participants | 312 Participants | 235 Participants | 839 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 713 | 0 / 760 | 0 / 587 |
| other Total, other adverse events | 0 / 713 | 0 / 760 | 0 / 587 |
| serious Total, serious adverse events | 0 / 713 | 0 / 760 | 0 / 587 |
Outcome results
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
Time frame: Baseline and three years
Population: primary preventions, primary + secondary prevention, control group (boys)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | BMI Z-score (Boys) | 0.022 z score | Standard Error 0.033 |
| Arm 2 | BMI Z-score (Boys) | 0.01 z score | Standard Error 0.03 |
| Arm 3 | BMI Z-score (Boys) | 0.055 z score | Standard Error 0.04 |
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
Time frame: Baseline and three years
Population: primary preventions, primary + secondary prevention, control group (girls)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | BMI Z-score (Girls) | .017 z score | Standard Error 0.021 |
| Arm 2 | BMI Z-score (Girls) | .069 z score | Standard Error 0.021 |
| Arm 3 | BMI Z-score (Girls) | .076 z score | Standard Error 0.025 |
% Body Fat (Boys)
change in percent body fat between Baseline and 3 years for boys
Time frame: Baseline and 3 years
Population: children in primary prevention, primary + secondary prevention, and control group (boys)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | % Body Fat (Boys) | -1.3 percentage of body fat | Standard Error 0.59 |
| Arm 2 | % Body Fat (Boys) | -2.0 percentage of body fat | Standard Error 0.54 |
| Arm 3 | % Body Fat (Boys) | -0.11 percentage of body fat | Standard Error 0.68 |
% Body Fat (Girls)
change in percent body fat between Baseline and 3 years for girls
Time frame: Baseline and 3 years
Population: children in primary prevention, primary + secondary prevention, and control group (girls)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | % Body Fat (Girls) | 2.8 percentage of body fat | Standard Error 0.34 |
| Arm 2 | % Body Fat (Girls) | 3.0 percentage of body fat | Standard Error 0.32 |
| Arm 3 | % Body Fat (Girls) | 3.9 percentage of body fat | Standard Error 0.39 |