Clinical trial NCT06416215: Promoting Positive Mental Health for Sustainable Eating Behaviors
Official title: Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: European Union
First posted: 2024-05-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The primary objective of this pilot study is to assess the effects and the effectiveness, both post-treatment and at 1- and 3-month follow-ups, of a group intervention inspired by the principles of Well-Being Therapy (WBT), combined with a nutritional education, compared to treatment as usual (TAU), namely a Basic Nutritional Intervention (BNI) in a group setting, in terms of weight loss.

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.

Eligibility 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).

Primary outcomes:
measure: Change from baseline in weight-loss
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
Secondary outcomes:
measure: Change from baseline in the Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
measure: Change from baseline in the Psychological Well-Being Scale (PWBs)
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
measure: Change from baseline in the Dutch Eating Behavior Questionnaire (DEBQ)
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
measure: Change from baseline in the Depression and Anxiety Stress Scale (DASS-21)
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
measure: Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form
timeFrame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,
Study officials:
affiliation: University of Bologna
name: Elena Tomba
role: STUDY_DIRECTOR
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria Letizia Petroni
role: PRINCIPAL_INVESTIGATOR
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