Trial Outcomes & Findings for The Louisiana (LA) Health Project (NCT NCT00289315)

NCT ID: NCT00289315

Last Updated: 2018-07-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2060 participants
• Primary outcome timeframe: Baseline and 3 years
• Results posted on: 2018-07-10

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Louisiana (LA) Health Project

Baseline characteristics by cohort

Measure	Arm 1 n=704 Participants 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.	Arm 2 n=725 Participants 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	Arm 3 n=586 Participants Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.	Total n=2015 Participants Total of all reporting groups
Age, Continuous	10.5 years STANDARD_DEVIATION 1.2 • n=5 Participants	10.5 years STANDARD_DEVIATION 1.2 • n=7 Participants	10.6 years STANDARD_DEVIATION 1.2 • n=5 Participants	10.5 years STANDARD_DEVIATION 1.2 • n=4 Participants
Sex: Female, Male Female	412 Participants n=5 Participants	413 Participants n=7 Participants	351 Participants n=5 Participants	1176 Participants n=4 Participants
Sex: Female, Male Male	292 Participants n=5 Participants	312 Participants n=7 Participants	235 Participants n=5 Participants	839 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 3 years

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

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

Outcome measures

Measure	Arm 1 n=292 Participants 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.	Arm 2 n=312 Participants 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	Arm 3 n=235 Participants Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
% Body Fat (Boys)	-1.3 percentage of body fat Standard Error 0.59	-2.0 percentage of body fat Standard Error 0.54	-0.11 percentage of body fat Standard Error 0.68

PRIMARY outcome

Timeframe: Baseline and three years

Population: primary preventions, primary + secondary prevention, control group (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

Outcome measures

Measure	Arm 1 n=292 Participants 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.	Arm 2 n=312 Participants 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	Arm 3 n=235 Participants Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
BMI Z-score (Boys)	0.022 z score Standard Error 0.033	0.01 z score Standard Error 0.03	0.055 z score Standard Error 0.04

PRIMARY outcome

Timeframe: Baseline and 3 years

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

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

Outcome measures

Measure	Arm 1 n=412 Participants 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.	Arm 2 n=413 Participants 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	Arm 3 n=351 Participants Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
% Body Fat (Girls)	2.8 percentage of body fat Standard Error .34	3.0 percentage of body fat Standard Error 0.32	3.9 percentage of body fat Standard Error 0.39

PRIMARY outcome

Timeframe: Baseline and three years

Population: primary preventions, primary + secondary prevention, control group (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

Outcome measures

Measure	Arm 1 n=412 Participants 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.	Arm 2 n=413 Participants 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	Arm 3 n=351 Participants Control Control: Control program that does not include an active intervention for promoting healthy eating and physical activity.
BMI Z-score (Girls)	.017 z score Standard Error .021	.069 z score Standard Error .021	.076 z score Standard Error .025

Adverse Events

Arm 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Steib

Pennington Biomedical Research Center

Phone: (225) 252-5030

Email: Lori.Steib@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place