Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245180
Status:
COMPLETED
Last Update Posted:
2014-03-12
First Post:
2005-10-26
Brief Title:
Preventing American Indian Children From Becoming Overweight
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
Primordial Prevention of Overweight in American Indian Children
Status:
COMPLETED
Status Verified Date:
2006-04
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:
The purpose of this study is to establish an intervention to keep American IndianAlaskan Native AIAN children from becoming overweight
Detailed Description:
BACKGROUND
AIAN children have overweight rates that are 18 to 30 percent higher than the general American population of children Adult obesity has early antecedents and data show that eating and physical activity behaviors are formed and set as early as 3 years of age through primary socialization within families Yet there are few if any obesity prevention programs that target children younger than 3 years of age
DESIGN NARRATIVE
This is a community-partnered randomized study to prevent early childhood overweight in AIAN children A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control 3 communities or intervention condition 3 communities The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers Nutrition goals are to increase breastfeeding initiation and sustainability limit sugared beverages for infants and toddlers and make healthful choices during weaning and solid food introduction Physical activity goals include promoting motor development limiting videoTV viewing and creating play opportunities for infants and toddlers Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the interventions feeding and physical activity components Each component in the community-wide interventions will be collaboratively designed with the tribes and tailored to each communitys needs Trained peer counselors will deliver the family interventions during a series of 12 cluster visits each covering a different developmental stage of the infanttoddler
AIAN children have overweight rates that are 18 to 30 percent higher than the general American population of children Adult obesity has early antecedents and data show that eating and physical activity behaviors are formed and set as early as 3 years of age through primary socialization within families Yet there are few if any obesity prevention programs that target children younger than 3 years of age
DESIGN NARRATIVE
This is a community-partnered randomized study to prevent early childhood overweight in AIAN children A birth cohort of about 780 children from six Indian communities born over a period 18 months will be randomized by community to either a control 3 communities or intervention condition 3 communities The intervention comprises a community-wide intervention coupled with individualized family counseling to improve nutrition and physical activity in infants and toddlers Nutrition goals are to increase breastfeeding initiation and sustainability limit sugared beverages for infants and toddlers and make healthful choices during weaning and solid food introduction Physical activity goals include promoting motor development limiting videoTV viewing and creating play opportunities for infants and toddlers Intervention approaches and methods used in the pilot study on which this project is based will be combined with new formative data collected at the beginning of the project to enhance the interventions feeding and physical activity components Each component in the community-wide interventions will be collaboratively designed with the tribes and tailored to each communitys needs Trained peer counselors will deliver the family interventions during a series of 12 cluster visits each covering a different developmental stage of the infanttoddler
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 |
|---|---|---|---|
| U01HL081624 | NIH | None | httpsreporternihgovquickSearchU01HL081624 |