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The Louisiana (LA) Health Project

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00289315
Enrollment
2060
Registered
2006-02-09
Start date
2005-08-31
Completion date
2009-05-31
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

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

BEHAVIORALPrimary (Environmental) Weight Gain Prevention

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

BEHAVIORALSecondary (Behavioral) Weight Gain Prevention

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

BEHAVIORALControl

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

Sponsors

United States Department of Agriculture (USDA)
CollaboratorFED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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

\-

Design outcomes

Primary

MeasureTime frameDescription
% Body Fat (Boys)Baseline and 3 yearschange in percent body fat between Baseline and 3 years for boys
BMI Z-score (Boys)Baseline and three yearsBody 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 yearschange in percent body fat between Baseline and 3 years for girls
BMI Z-score (Girls)Baseline and three yearsBody 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

ArmCount
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
Total2,015

Baseline characteristics

CharacteristicArm 1Arm 2Arm 3Total
Age, Continuous10.5 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 Participants413 Participants351 Participants1176 Participants
Sex: Female, Male
Male
292 Participants312 Participants235 Participants839 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 7130 / 7600 / 587
other
Total, other adverse events
0 / 7130 / 7600 / 587
serious
Total, serious adverse events
0 / 7130 / 7600 / 587

Outcome results

Primary

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)

ArmMeasureValue (MEAN)Dispersion
Arm 1BMI Z-score (Boys)0.022 z scoreStandard Error 0.033
Arm 2BMI Z-score (Boys)0.01 z scoreStandard Error 0.03
Arm 3BMI Z-score (Boys)0.055 z scoreStandard Error 0.04
Primary

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)

ArmMeasureValue (MEAN)Dispersion
Arm 1BMI Z-score (Girls).017 z scoreStandard Error 0.021
Arm 2BMI Z-score (Girls).069 z scoreStandard Error 0.021
Arm 3BMI Z-score (Girls).076 z scoreStandard Error 0.025
Primary

% 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)

ArmMeasureValue (MEAN)Dispersion
Arm 1% Body Fat (Boys)-1.3 percentage of body fatStandard Error 0.59
Arm 2% Body Fat (Boys)-2.0 percentage of body fatStandard Error 0.54
Arm 3% Body Fat (Boys)-0.11 percentage of body fatStandard Error 0.68
Primary

% 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)

ArmMeasureValue (MEAN)Dispersion
Arm 1% Body Fat (Girls)2.8 percentage of body fatStandard Error 0.34
Arm 2% Body Fat (Girls)3.0 percentage of body fatStandard Error 0.32
Arm 3% Body Fat (Girls)3.9 percentage of body fatStandard Error 0.39

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026