Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065247
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-07-18
Brief Title:
The BONES Project Building Healthy Bones in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Beat Osteoporosis Nourish and Exercise Skeletons BONES
Status:
UNKNOWN
Status Verified Date:
2003-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The Beat Osteoporosis Nourish and Exercise Skeletons BONES Project is an after-school program that includes weight loading physical activity nutrition and bone health education and calcium-rich snacks The program is designed to improve bone health in early elementary school children
Detailed Description:
Osteoporosis is a serious public health concern expected to threaten 52 million Americans by the year 2010 This debilitating disease comes at an annual cost of 17 billion By optimizing bone development during the growing years individuals can lower their risk of osteoporosis by building an adequate reserve of bone This study will implement and evaluate an after-school program with exercise education and diet components designed to improve bone quality and muscle strength in early elementary school children
First and second grade children from 84 after school programs in 33 diverse communities throughout Massachusetts and Rhode Island will be enrolled in the study After-school programs will be randomized to either the BONES Project to the BONES Project plus a parentcaregiver component or to a no-intervention control group The BONES curriculum will be implemented 4 days per week over a 20- to 25-week period each after-school program will implement the program for 2 years Participants will be followed for an additional year assuming they remain in the after-school program or do not withdraw for some other reason All parents will be asked to complete a Child Medical History survey and a Parent Health Survey at baseline during the 2-year intervention and at the end of the follow-up year Parents in the BONES Project plus parentcaregiver component will receive a newsletter and worksheet 5 times per year
Participants will be assessed by quantitative ultrasound height weight and body composition measurements muscular strength self competence physical activity level food knowledge and preference calcium intake perceived parental support and sleep habits
First and second grade children from 84 after school programs in 33 diverse communities throughout Massachusetts and Rhode Island will be enrolled in the study After-school programs will be randomized to either the BONES Project to the BONES Project plus a parentcaregiver component or to a no-intervention control group The BONES curriculum will be implemented 4 days per week over a 20- to 25-week period each after-school program will implement the program for 2 years Participants will be followed for an additional year assuming they remain in the after-school program or do not withdraw for some other reason All parents will be asked to complete a Child Medical History survey and a Parent Health Survey at baseline during the 2-year intervention and at the end of the follow-up year Parents in the BONES Project plus parentcaregiver component will receive a newsletter and worksheet 5 times per year
Participants will be assessed by quantitative ultrasound height weight and body composition measurements muscular strength self competence physical activity level food knowledge and preference calcium intake perceived parental support and sleep habits
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