Promoting Positive Mental Health for Sustainable Eating Behaviors

Last updated: May 16, 2024
Sponsor: University of Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Basic Nutritional Intervention

Psychological intervention based on WBT and cognitive restructuring

Clinical Study ID

NCT06416215
PROMISE_BO_2024
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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).

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Basic Nutritional Intervention
Phase:
Study Start date:
January 30, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

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

    Bologna,
    Italy

    Active - Recruiting

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