Promoting Positive Mental Health for Sustainable Eating Behaviors

NCT06416215 | Completed

• 1 other identifier: PROMISE_BO_2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weight-loss

  Body weight will be both self-evaluated by patients and will be verified by the medical staff during follow-up visits

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

Secondary Outcomes (5)

• Change from baseline in the Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

• Change from baseline in the Psychological Well-Being Scale (PWBs)

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

• Change from baseline in the Dutch Eating Behavior Questionnaire (DEBQ)

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

• Change from baseline in the Depression and Anxiety Stress Scale (DASS-21)

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

• Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form

  Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

Study Arms (2)

Psychological intervention based on WBT and cognitive restructuring

EXPERIMENTAL

Six weekly online sessions of two hours of a psychological intervention based on WBT elements and cognitive restructuring combined with a nutritional education.

Other: Psychological intervention based on WBT and cognitive restructuring

Basic Nutritional Intervention

ACTIVE COMPARATOR

Six weekly online sessions of two hours of a nutritional education.

Other: Basic Nutritional Intervention

Interventions

Psychological intervention based on WBT and cognitive restructuring OTHER

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.

Psychological intervention based on WBT and cognitive restructuring

Basic Nutritional Intervention OTHER

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.

Basic Nutritional Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are included in the study if they:
• are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi;
• have a BMI ≥ 30;
• are aged ≥ 18 years;
• voluntarily agree to participate in the study;
• have access to a computer and can use it independently.

You may not qualify if:

• Patients are excluded from the study if they:
• do not sign the informed consent to participate in the study;
• have limited knowledge of the Italian language;
• have cognitive deficits;
• 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;
• participate in another weight loss study or program;
• take weight loss medications;
• engage in individual or group psychotherapeutic interventions;
• have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months);
• (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).

Sponsors & Collaborators

• University of Bologna: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• European Union: collaborator

Study Sites (1)

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

Bologna, Italy

Location

Related Publications (32)

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MeSH Terms

Conditions

Obesity

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elena Tomba

  University of Bologna

  STUDY DIRECTOR

• Maria Letizia Petroni

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 16, 2024
• Study Start: January 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

IT (1)