Promoting Positive Mental Health for Sustainable Eating Behaviors
NCT ID: NCT06416215
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-01-30
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Psychological intervention based on WBT and cognitive restructuring
Six weekly online sessions of two hours of a psychological intervention based on WBT elements and cognitive restructuring combined with a nutritional education.
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.
Basic Nutritional Intervention
Six weekly online sessions of two hours of a nutritional education.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
European Union
OTHER
University of Bologna
OTHER
Responsible Party
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Elena Tomba
Associate Professor
Principal Investigators
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Elena Tomba
Role: STUDY_DIRECTOR
University of Bologna
Maria Letizia Petroni
Role: PRINCIPAL_INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Locations
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IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PROMISE_BO_2024
Identifier Type: -
Identifier Source: org_study_id
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