Promoting Positive Mental Health for Sustainable Eating Behaviors (PROMISE)

April 29, 2026 updated by: Elena Tomba, University of Bologna

Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Active Comparator: Basic Nutritional Intervention
Six weekly online sessions of two hours of a nutritional education.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in weight-loss
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
An ad-hoc assessment index adapted from a previous study will be used to assess dysfunctional cognitive justification mechanisms through the presentation of three hypothetical scenarios that could pose dilemmas regarding the adherence to a healthy diet. Participants will be asked to assess their level of identification with the scenario (from 1 to 10) and to specify the type of justification most frequently used in similar situations.
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 Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
The Sustainable and Healthy Dietary Behaviors (SHDB) is 30-item self-reported questionnaire on a 6-point Likert scale to assess sustainable and healthy dietary behaviors through five dimensions and the total score: food choices, storing, cooking, food consumption and food disposal. For each sub-scale and the total score, scores range from 0 to 6, with higher scores indicating more sustainable and healthy eating behaviors (better outcome).
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)
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
The Psychological Well-Being Scale (PWBs) is a 42-item self-reported questionnaire on a 6-point Likert scale that assesses psychological well-being through six dimensions: autonomy, personal growth, environmental mastery, purpose in life, acceptance and positive relations with others. For each dimension scores range from 14 to 84, with higher scores indicating higher levels on that specific PWB dimension (better outcome).
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)
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

The Dutch Eating Behavior Questionnaire (DEBQ) is 33-item self-reported questionnaire on a 5-point Likert scale to assess eating styles through three sub-scales: restrictive eating, emotional eating and external eating.

For each sub-scale scores range from 1 to 5, with higher scores indicating higher levels on that specific dimension (worse outcome).
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)
Time Frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

The Depression and Anxiety Stress Scale (DASS-21) is a 21-item self-reported questionnaire on a 4-point Likert scale to assess psychological distress through three subscales: depression, anxiety and stress.

For each sub-scale scores range from 0 to 56, with higher scores indicating higher levels on that specific dimension (worse outcome).
Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
European Union

Investigators

  • Study Director: Elena Tomba, University of Bologna
  • Principal Investigator: Maria Letizia Petroni, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMISE_BO_2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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