CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Psychological intervention based on WBT and cognitive restructuring +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06416215
NCT06416215N/ACompleted

Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity

University of Bologna·interventional·Posted May 16, 2024·Updated Apr 30, 2026

In Brief

A clinical study evaluating Psychological intervention based on WBT and cognitive restructuring and Basic Nutritional Intervention for Obesity. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesItaly

Timeline

N/ACompletedFinished
202420252026
First PostedMay 16, 2024
Enrollment StartJan 30, 2024
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.1 years ago

Interventions

Psychological intervention based on WBT and cognitive restructuringother

Participants will engage in 6 weekly group session of two hours. One part will be held by a trained dietician and will focus on nutritional education, particularly emphasizing the adoption of healthy and sustainable eating behaviors. The remaining part will be dedicated to a group psychological intervention inspired by the principles of Well-Being Therapy and will be held by a trained psychologist. During these sessions, participants will be introduced to the six dimensions of psychological well-being and will be gradually provided with cognitive-behavioral strategies to enhance psychological well-being and seek a balance between the presented dimensions. Participants will be given cognitive-behavioral tools to recognize justification cognitive mechanisms and replace them with more functional cognitions. These objectives will also be achieved through the use of a food diary to highlight emotions and thoughts experienced during food intake.

Basic Nutritional Interventionother

Participants will receive treatment as usual (TAU) by participating in 6 weekly group sessions of two hours of a Basic Nutritional Intervention (BNI) held by a trained dietician. This course focuses on promoting healthier lifestyles through nutritional education, diet monitoring using a dedicated food diary, and recommendations for proper physical activity.