Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416215
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Promoting Positive Mental Health for Sustainable Eating Behaviors
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Promoting Positive Mental Health for Sustainable Eating Behaviors the PROMISE Study in Patients With Obesity
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PROMISE
Brief Summary:
The main aim of the present study is to assess the effects and the effectiveness of a psychological intervention based on the principles of well-being therapy WBT in promoting weight-loss sustainable and healthy eating behaviors and an optimal psychological functioning in patients with obesity
Detailed Description:
The primary objective of this pilot study is to assess the effects and the effectiveness both post-treatment and at 1- and 3-month follow-ups of a group intervention inspired by the principles of Well-Being Therapy WBT combined with a nutritional education compared to treatment as usual TAU namely a Basic Nutritional Intervention BNI in a group setting in terms of weight loss
The secondary objective is to evaluate the effects and effectiveness of this intervention both post-treatment and at 1- and 3-month follow-ups compared to BNI in promoting healthy and sustainable eating behaviors and an optimal psychological functioning This includes the promotion of balanced psychological well-being levels and functional eating styles and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use
After being informed about the study and its potential risks all patients giving written informed consent will be randomly assigned to either the experimental group or the control group Both groups will participate in five weekly online group sessions of two hours each
The secondary objective is to evaluate the effects and effectiveness of this intervention both post-treatment and at 1- and 3-month follow-ups compared to BNI in promoting healthy and sustainable eating behaviors and an optimal psychological functioning This includes the promotion of balanced psychological well-being levels and functional eating styles and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use
After being informed about the study and its potential risks all patients giving written informed consent will be randomly assigned to either the experimental group or the control group Both groups will participate in five weekly online group sessions of two hours each
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