Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495619
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity A Multidisciplinary Approach
Status:
NOT_YET_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:
BE-side
Brief Summary:
The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweightobesity and binge eating BE
1 treatment-as-usual for weight loss TAU
2 combined TAU and guided self-help for improving eating behaviors TAUGSH
3 combined TAU GSH and biofeedback TAUGSHBF The primary outcomes will be self-reported reduction of days with objective BE episodes OBEs
The secondary outcomes will be impulsivity emotion dysregulation interoceptive awareness distress physiological correlates of arousal skin conductance and heart rate variability and inflammatory biomarkers
The TAUGSH arm is expected to be comparable to the TAUGSHBF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes impulsivity emotional dysregulation interoceptive awareness distress physiological inflammatory markers The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAUGSH and TAUGSHBF conditions
1 treatment-as-usual for weight loss TAU
2 combined TAU and guided self-help for improving eating behaviors TAUGSH
3 combined TAU GSH and biofeedback TAUGSHBF The primary outcomes will be self-reported reduction of days with objective BE episodes OBEs
The secondary outcomes will be impulsivity emotion dysregulation interoceptive awareness distress physiological correlates of arousal skin conductance and heart rate variability and inflammatory biomarkers
The TAUGSH arm is expected to be comparable to the TAUGSHBF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes impulsivity emotional dysregulation interoceptive awareness distress physiological inflammatory markers The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAUGSH and TAUGSHBF conditions
Detailed Description:
None
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