Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185978
Status:
COMPLETED
Last Update Posted:
2005-09-16
First Post:
2005-09-12
Brief Title:
Obesity Prevention for Pre-Adolescents
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
School- and Family-Based Obesity Prevention for Children
Status:
COMPLETED
Status Verified Date:
2005-09
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 develop and evaluate in a randomized controlled trial a comprehensive obesity prevention program for third fourth and fifth grade students
The intervention includes activities in THE SCHOOL THE HOME and a clinically oriented component for HIGH-RISK CHILDREN In addition the intervention will be delivered over a 3 year period with age and grade-appropriate components for 3rd 4th and 5th graders and their families The primary outcome is body mass index
PRIMARY OBJECTIVE To significantly reduce body mass index compared to controls at the end of the three year intervention
The intervention includes activities in THE SCHOOL THE HOME and a clinically oriented component for HIGH-RISK CHILDREN In addition the intervention will be delivered over a 3 year period with age and grade-appropriate components for 3rd 4th and 5th graders and their families The primary outcome is body mass index
PRIMARY OBJECTIVE To significantly reduce body mass index compared to controls at the end of the three year intervention
Detailed Description:
To develop and evaluate in a randomized controlled trial a comprehensive obesity prevention program for third fourth and fifth grade students
Late childhood and early adolescence appears to be an important period in the development of obesity Physiologic changes associated with puberty may increase the risk of acquiring clinically significant obesity Onset of obesity in early adolescence appears to be associated with increased risks of tracking of obesity into adulthood obesity-associated morbidity and mortality in adulthood and obesity-associated psychosocial morbidity However 1 we have a limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities 2 most existing treatments for overweight children and adolescents have yielded modest unsustained effects and 3 single-component preventive interventions have been relatively ineffective Acknowledging these observations the consensus at the recent NHLBI Strategy Development Workshop for Public Education on Weight and Obesity was that population-based primary and secondary prevention efforts targeting pre-adolescents may hold the greatest promise for addressing the problem of obesity Therefore we propose an integrated multiple-component school and family-based primary and secondary prevention program targeting third fourth and fifth graders
Our proposed intervention model is derived directly from principles of Banduras social cognitive theory The intervention includes activities in THE SCHOOL THE HOME and a clinically oriented component for HIGH-RISK CHILDREN In addition the intervention will be delivered over a 3 year period with age and grade-appropriate components for 3rd 4th and 5th graders and their families
We will evaluate the efficacy of our comprehensive intervention in a cohort of third graders in ethnically diverse elementary schools Schools will be randomly assigned to the comprehensive intervention or an attention-placebo curriculum to minimize the potential for compensatory rivalry or resentful demoralization Assessments of childrens height weight triceps skinfold thickness waist and hip circumferences food preferences cardio-respiratory fitness and self-reported behavior attitudes and knowledge will occur every 6 months and 6-months following the end of the intervention The primary outcome is body mass index
PRIMARY OBJECTIVE To significantly reduce body mass index compared to controls at the end of the three year intervention
Late childhood and early adolescence appears to be an important period in the development of obesity Physiologic changes associated with puberty may increase the risk of acquiring clinically significant obesity Onset of obesity in early adolescence appears to be associated with increased risks of tracking of obesity into adulthood obesity-associated morbidity and mortality in adulthood and obesity-associated psychosocial morbidity However 1 we have a limited ability to accurately identify those children who will become obese adults and those who will suffer obesity-related morbidities 2 most existing treatments for overweight children and adolescents have yielded modest unsustained effects and 3 single-component preventive interventions have been relatively ineffective Acknowledging these observations the consensus at the recent NHLBI Strategy Development Workshop for Public Education on Weight and Obesity was that population-based primary and secondary prevention efforts targeting pre-adolescents may hold the greatest promise for addressing the problem of obesity Therefore we propose an integrated multiple-component school and family-based primary and secondary prevention program targeting third fourth and fifth graders
Our proposed intervention model is derived directly from principles of Banduras social cognitive theory The intervention includes activities in THE SCHOOL THE HOME and a clinically oriented component for HIGH-RISK CHILDREN In addition the intervention will be delivered over a 3 year period with age and grade-appropriate components for 3rd 4th and 5th graders and their families
We will evaluate the efficacy of our comprehensive intervention in a cohort of third graders in ethnically diverse elementary schools Schools will be randomly assigned to the comprehensive intervention or an attention-placebo curriculum to minimize the potential for compensatory rivalry or resentful demoralization Assessments of childrens height weight triceps skinfold thickness waist and hip circumferences food preferences cardio-respiratory fitness and self-reported behavior attitudes and knowledge will occur every 6 months and 6-months following the end of the intervention The primary outcome is body mass index
PRIMARY OBJECTIVE To significantly reduce body mass index compared to controls at the end of the three year intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL054102 | NIH | None | httpsreporternihgovquickSearchR01HL054102 |