RECRUITINGINTERVENTIONAL

Promoting Positive Mental Health for Sustainable Eating Behaviors

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

About This Trial

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.

Who May Be Eligible (Plain English)

INCLUSION CRITERIA Patients are included in the study if they: 1. are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi; 2. have a BMI ≥ 30; 3. are aged ≥ 18 years; 4. voluntarily agree to participate in the study; 5. have access to a computer and can use it independently. EXCLUSION CRITERIA Patients are excluded from the study if they: 1. do not sign the willing to sign a consent form to participate in the study; 2. have limited knowledge of the Italian language; 3. have cognitive deficits; 4. meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors; 5. participate in another weight loss study or program; 6. take weight loss medications; 7. engage in individual or group psychotherapeutic interventions; 8. have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months); 9. (only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

INCLUSION CRITERIA Patients are included in the study if they: 1. are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi; 2. have a BMI ≥ 30; 3. are aged ≥ 18 years; 4. voluntarily agree to participate in the study; 5. have access to a computer and can use it independently. EXCLUSION CRITERIA Patients are excluded from the study if they: 1. do not sign the informed consent to participate in the study; 2. have limited knowledge of the Italian language; 3. have cognitive deficits; 4. meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors; 5. participate in another weight loss study or program; 6. take weight loss medications; 7. engage in individual or group psychotherapeutic interventions; 8. have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months); 9. (only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months).

Treatments Being Tested

OTHER

Psychological intervention based on WBT and cognitive restructuring

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.

OTHER

Basic Nutritional Intervention

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.

Locations (1)

IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,

Bologna, Italy