Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570707
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cluster-Randomized Controlled Trial RCT to Evaluate the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the effects of the Brighter Bites BB intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes HbA1c and vegetable intake on changes in secondary outcomes household food security status parent and child dietary behaviors and home accessavailability of fruits and vegetables FV and the mediational influence of changes in food security status parent outcomes and home environment measures on changes in child outcomes
Detailed Description:
The purpose of this study is to examine the effects of the Brighter Bites BB intervention compared to wait-list control at post intervention on changes in primary child outcomes HbA1c and vegetable intake to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes household food security status parent and child dietary behaviors and home accessavailability of fruits and vegetables FVto examine the mediational influence of changes in food security status parent outcomes and home environment measures on changes in child outcomes at 9-month post-intervention using within-subject analyses examine and compare the long-term and dose-response effects of the BB intervention strategies on diet adiposity and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness
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