The Louisiana (LA) Health Project

• Sponsor: Pennington Biomedical Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00289315
• Collaborator: United States Department of Agriculture (USDA) (U.S. Fed), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 2,060
• Location: 1
• Arms: 3
• Duration (Months): 45
• Patients Per Site Per Month: 45.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Obesity	Behavioral: Primary (Environmental) Weight Gain Prevention; Behavioral: Secondary (Behavioral) Weight Gain Prevention; Behavioral: Control	N/A

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
• Actual Enrollment: 2060 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: LA Health: A Prospective Study of Primary and Secondary Obesity Prevention in Children and Adolescents
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. % Body Fat (Boys) [Baseline and 3 years]

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

2. 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

3. % Body Fat (Girls) [Baseline and 3 years]

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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corby K. Martin, Professor, Pennington Biomedical Research Center
• ClinicalTrials.gov Identifier: NCT00289315
• Other Study ID Numbers: LA Health; R01HD048483-01
• First Posted: Feb 9, 2006
• Last Update Posted: Jul 10, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Pediatric Obesity

Study Results

Participant Flow

Arm/Group Title	Arm 1-Primary Prevention of Weight Gain	Arm 2-Primary and Secondary Weight Gain Prevention Program	Arm 3-Control
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
Period Title: Overall Study
STARTED	713	760	587
COMPLETED	612	638	447
NOT COMPLETED	101	122	140

Baseline Characteristics

Arm/Group Title	Arm 1	Arm 2	Arm 3	Total
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.	Total of all reporting groups
Overall Participants	704	725	586	2015
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.5 (1.2)	10.5 (1.2)	10.6 (1.2)	10.5 (1.2)
Sex: Female, Male (Count of Participants)
Female	412 58.5%	413 57%	351 59.9%	1176 58.4%
Male	292 41.5%	312 43%	235 40.1%	839 41.6%

Outcome Measures

1. Primary Outcome

Title	% Body Fat (Boys)
Description	change in percent body fat between Baseline and 3 years for boys
Time Frame	Baseline and 3 years

Outcome Measure Data

Analysis Population Description

children in primary prevention, primary + secondary prevention, and control group (boys)

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
Measure Participants	292	312	235
Mean (Standard Error) [percentage of body fat]	-1.3 (0.59)	-2.0 (0.54)	-0.11 (0.68)

2. Primary Outcome

Title	BMI Z-score (Boys)
Description	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

Outcome Measure Data

Analysis Population Description

primary preventions, primary + secondary prevention, control group (boys)

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
Measure Participants	292	312	235
Mean (Standard Error) [z score]	0.022 (0.033)	0.01 (0.03)	0.055 (0.04)

3. Primary Outcome

Title	% Body Fat (Girls)
Description	change in percent body fat between Baseline and 3 years for girls
Time Frame	Baseline and 3 years

Outcome Measure Data

Analysis Population Description

children in primary prevention, primary + secondary prevention, and control group (girls)

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
Measure Participants	412	413	351
Mean (Standard Error) [percentage of body fat]	2.8 (.34)	3.0 (0.32)	3.9 (0.39)

4. Primary Outcome

Title	BMI Z-score (Girls)
Description	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

Outcome Measure Data

Analysis Population Description

primary preventions, primary + secondary prevention, control group (girls)

Arm/Group Title	Arm 1	Arm 2	Arm 3
Arm/Group Description	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.	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	Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
Measure Participants	412	413	351
Mean (Standard Error) [z score]	.017 (.021)	.069 (.021)	.076 (.025)

Adverse Events

Time Frame	Three years
Arm/Group Title	Arm 1		Arm 2		Arm 3
Arm/Group Description	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.		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		Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
All Cause Mortality
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/713 (0%)		0/760 (0%)		0/587 (0%)
Serious Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/713 (0%)		0/760 (0%)		0/587 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1		Arm 2		Arm 3
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/713 (0%)		0/760 (0%)		0/587 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.