Skip to main content
Clinical Trials/NCT00289315
NCT00289315CompletedNot Applicable

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

Pennington Biomedical Research Center1 site in 1 country2,060 target enrollmentStarted: August 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,060
Locations
1
Primary Endpoint
% Body Fat (Boys)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
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

  • Not provided

Arms & Interventions

Arm 1

Experimental

Primary (Environmental) Prevention of Weight Gain

Intervention: Primary (Environmental) Weight Gain Prevention (Behavioral)

Arm 2

Experimental

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

Intervention: Primary (Environmental) Weight Gain Prevention (Behavioral)

Arm 2

Experimental

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

Intervention: Secondary (Behavioral) Weight Gain Prevention (Behavioral)

Arm 3

Experimental

Control - no Environmental or Behavioral Program intervention

Intervention: Control (Behavioral)

Outcomes

Primary Outcomes

% Body Fat (Boys)

Time Frame: Baseline and 3 years

change in percent body fat between Baseline and 3 years for boys

BMI Z-score (Boys)

Time Frame: 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)

Time Frame: Baseline and 3 years

change in percent body fat between Baseline and 3 years for girls

BMI Z-score (Girls)

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Corby K. Martin

Professor

Pennington Biomedical Research Center

Study Sites (1)

Loading locations...

Similar Trials