Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207110
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-01-05
Brief Title:
Family Responsibility Education Support and Health for Food Responsiveness
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Addressing Appetitive Traits to Promote Weight Management in Children Who Overeat
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FRESH-FR
Brief Summary:
The objective of this proposed study is to compare Regulation of Cues ROC Family-Based Treatment FBT ROC nutrition education and reducing energy intake ROC and a health education comparator HE for children with overweight or obesity who are high on food responsiveness FR
Detailed Description:
The investigators have developed a new model for the treatment of obesity called Regulation of Cues ROC which is based on Behavioral Susceptibility Theory The ROC program targets two theorized mechanisms for overeating decreased sensitivity to appetitive cues and increased sensitivity to external food cues Considering that FBT has merit for some children but not all this study will compare ROC to FBT ROC with nutrition education and reducing energy intake ROC and Health Education HE Treatment will consist of weekly individual sessions for the first 16 sessions then twice per month for the final 2 months for a total of 20 sessions The investigators will recruit children ages 7-12 with overweight or obesity who are high in food responsiveness FR and their parent and will conduct assessments at baseline post-treatment month 6 6-month follow-up month 12 and 12-month follow-up month 18
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DK135599 | NIH | None | httpsreporternihgovquickSearch1R01DK135599 |