Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005750
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2000-05-25
Brief Title:
School and Family-Based Obesity Prevention for Children
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct an integrated multiple-component school- and community-based intervention targeting both primary and secondary prevention of obesity among third-fourth-and fifth-graders School- and Family-Based Obesity Prevention for Children
Detailed Description:
BACKGROUND
An estimated 25-40 percent of United States pre-adolescents and adolescents are obese Higher rates have been noted among minority youth Onset of obesity in late childhood and early adolescence is associated with increased risks of tracking of obesity into adulthood subsequent obesity-related morbidity and mortality and obesity- related psychosocial morbidity However there is limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities Existing treatments for child and adolescent obesity have yielded modest unsustained effects and single-component prevention interventions have been relatively ineffective
DESIGN NARRATIVE
The intervention model was derived from principles of Banduras social cognitive theory and included activities in the school and the home and a clinically oriented component for high-risk children The school component included a computer-based classroom curriculum a physical education curriculum and a school lunch intervention The home component included correspondence materials and a videotape for parents Children identified as high risk were eligible to enroll in an intensive intervention In addition several innovative approaches were included interventions to influence food preferences and television viewing interventions promoting health advocacy and computer-assisted instruction
An efficacy trial evaluated the three-year intervention in a cohort of approximately 1200 3rd graders in 14 ethnically diverse elementary schools with follow-up in the 6th grade 7 schools were randomly assigned to the comprehensive intervention and 7 schools received an attention-placebo classroom curriculum Anthropometric measures and assessments of food preferences cardio-respiratory fitness and self-reported behavior attitudes and knowledge occurred every six months Parent interviews occurred annually Although a careful assessment of effects on parents and the schools was conducted the crucial question was whether the overall intervention had an impact on student adiposity and behaviors
The primary objective was to significantly reduce the prevalence of obesity compared to controls at the end of the three year intervention Secondary objectives included maintenance of effects at 6-month follow-up reducing obesity among high-risk children improving cardio-respiratory fitness increasing physical activity decreasing sedentary activity reducing the prevalence of unhealthful weight control methods and improving knowledge attitudes and perceived self-efficacy regarding the adoption of healthful behaviors In addition the investigators identified personal behavioral and environmental including family factors prospectively associated with development of obesity maintenance of normal weight weight reduction among overweight children and obesity-related behaviors Finally they examined longitudinal changes in height weight body mass index BMI triceps skin fold thickness and waist and hip circumferences in girls and boys 8 - 12 years of age with respect to stages of pubertal development
An estimated 25-40 percent of United States pre-adolescents and adolescents are obese Higher rates have been noted among minority youth Onset of obesity in late childhood and early adolescence is associated with increased risks of tracking of obesity into adulthood subsequent obesity-related morbidity and mortality and obesity- related psychosocial morbidity However there is limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities Existing treatments for child and adolescent obesity have yielded modest unsustained effects and single-component prevention interventions have been relatively ineffective
DESIGN NARRATIVE
The intervention model was derived from principles of Banduras social cognitive theory and included activities in the school and the home and a clinically oriented component for high-risk children The school component included a computer-based classroom curriculum a physical education curriculum and a school lunch intervention The home component included correspondence materials and a videotape for parents Children identified as high risk were eligible to enroll in an intensive intervention In addition several innovative approaches were included interventions to influence food preferences and television viewing interventions promoting health advocacy and computer-assisted instruction
An efficacy trial evaluated the three-year intervention in a cohort of approximately 1200 3rd graders in 14 ethnically diverse elementary schools with follow-up in the 6th grade 7 schools were randomly assigned to the comprehensive intervention and 7 schools received an attention-placebo classroom curriculum Anthropometric measures and assessments of food preferences cardio-respiratory fitness and self-reported behavior attitudes and knowledge occurred every six months Parent interviews occurred annually Although a careful assessment of effects on parents and the schools was conducted the crucial question was whether the overall intervention had an impact on student adiposity and behaviors
The primary objective was to significantly reduce the prevalence of obesity compared to controls at the end of the three year intervention Secondary objectives included maintenance of effects at 6-month follow-up reducing obesity among high-risk children improving cardio-respiratory fitness increasing physical activity decreasing sedentary activity reducing the prevalence of unhealthful weight control methods and improving knowledge attitudes and perceived self-efficacy regarding the adoption of healthful behaviors In addition the investigators identified personal behavioral and environmental including family factors prospectively associated with development of obesity maintenance of normal weight weight reduction among overweight children and obesity-related behaviors Finally they examined longitudinal changes in height weight body mass index BMI triceps skin fold thickness and waist and hip circumferences in girls and boys 8 - 12 years of age with respect to stages of pubertal development
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL054102 | NIH | None | httpsreporternihgovquickSearchR01HL054102 |