Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT05586269
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2022-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Status:
COMPLETED
Status Verified Date:
2025-05
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 goals of this study are to 1) pilot the feasibility of a novel meal kit delivery intervention in families and children with food insecurity and obesity and 2) evaluate the implementation of the pilot intervention.
Detailed Description:
Childhood obesity prevalence is rising in the U.S. and is known to track into adulthood, increasing the risks of chronic diseases such as type 2 diabetes. Households of children with obesity also face unmet social needs, such as food insecurity. Food insecurity is associated with poorer dietary quality and higher prevalence of obesity and diabetes in adults; however, data are inconsistent and less known regarding longitudinal health effects in children. Because food insecurity and childhood obesity tend to co-occur in Black, Hispanic, and lower-income households, there is an urgent need to examine and intervene in the social determinants associated with rising childhood obesity prevalence.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: