Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532747
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Redefining BMI The Body Mind and Inflammation Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Redefining BMI The Body Mind and Inflammation Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Emerging adulthood 18-25 years of age represents a critical developmental window for promoting cardiometabolic health given high rates of obesity proinflammatory behaviors life stressors and psychological symptoms-all of which perpetuate chronic low-level inflammation thereby increasing cardiometabolic risk Furthermore the prevalence of obesity among emerging adults EA has increased five-fold over the last 4 decades-over half of EAs meet criteria for overweight or obesity Yet very few behavioral obesity management trials focus specifically on EAs Those that do have produced modest treatment effects with EA women experiencing considerably less benefit than EA men-a pattern even more pronounced for Black and Latina EA women Thus efforts are urgently needed to enhance behavioral obesity treatment outcomes among EA women
Detailed Description:
EA women are also at disproportionate risk for psychological dysregulation EAs experience the highest rates of perceived stress relative to any other age group with EA women experiencing intersectional stress related to multiple aspects of their identity eg gender race ethnicity body size coupled with life stressors unique to emerging adulthood Further prevalence of major depressive episodes is highest among 18-25-year-olds relative to other age groups and higher among women than men Our preliminary data suggest exposure to life events insufficient sleep depressive symptoms and perceived stress interfere with weight loss treatment benefit in EAs This blunted treatment response is not due to insufficient engagement in self-monitoring behaviors rather we posit that the cognitive processing required for effective self-regulation is disrupted by inflammatory cytokine activity Extant behavioral weight loss programs are insufficient to address underlying behavioralpsychological dysregulation and do not promote behavior change through the lens of inflammation Thus a new model is needed to optimize clinical impact in this high-risk population
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