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Completed

NCT Number: NCT06416215

Promoting Positive Mental Health for Sustainable Eating Behaviors

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bologna, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

  • European Union
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Registry information

Official study title

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

Acronym: PROMISE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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