Improving mental health to support healthy eating habits
Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity
NA · University of Bologna · NCT06416215
This study is testing if a combination of mental health support and nutrition education can help people with obesity lose weight and develop healthier eating habits.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Bologna (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06416215 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a psychological intervention based on Well-Being Therapy (WBT) combined with nutritional education to promote weight loss and sustainable eating behaviors in patients with obesity. Participants will be randomly assigned to either the experimental group receiving WBT and nutritional education or a control group receiving basic nutritional intervention. The study will assess outcomes post-treatment and at 1- and 3-month follow-ups, focusing on weight loss, psychological well-being, and eating behaviors. The intervention consists of five weekly online group sessions lasting two hours each.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI of 30 or higher who can participate in online sessions.
Not a fit: Patients with significant psychiatric disorders, cognitive deficits, or those currently engaged in other weight loss programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved weight loss and healthier eating habits for patients with obesity.
How similar studies have performed: While the specific combination of WBT and nutritional education is novel, similar psychological interventions have shown promise in promoting weight loss and healthy behaviors.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Bologna
- IRCCS-S. Orsola-Malpighi Hospital, University of Bologna, — Bologna, Italy (RECRUITING)
Study contacts
- Principal investigator: Maria Letizia Petroni — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Elena Tomba
- Email: elena.tomba@unibo.it
- Phone: +390512091339
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity