## Protocol Section
### Identification Module
**NCT ID:** NCT06416215

**Acronym:** PROMISE

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PROMISE_BO_2024
#### Organization
**Class:** OTHER
**Full Name:** University of Bologna
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** IRCCS Azienda Ospedaliero-Universitaria di Bologna

**Class:** OTHER

**Name:** European Union

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Bologna

#### Responsible Party

**Investigator Affiliation:** University of Bologna

**Investigator Full Name:** Elena Tomba

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Obesity

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Six weekly online sessions of two hours of a psychological intervention based on WBT elements and cognitive restructuring combined with a nutritional education.

**Intervention Names:**

- Other: Psychological intervention based on WBT and cognitive restructuring

**Label:** Psychological intervention based on WBT and cognitive restructuring

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Six weekly online sessions of two hours of a nutritional education.

**Intervention Names:**

- Other: Basic Nutritional Intervention

**Label:** Basic Nutritional Intervention

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Psychological intervention based on WBT and cognitive restructuring

**Description:** 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.

**Name:** Psychological intervention based on WBT and cognitive restructuring

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Basic Nutritional Intervention

**Description:** 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.

**Name:** Basic Nutritional Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Body weight will be both self-evaluated by patients and will be verified by the medical staff during follow-up visits

**Measure:** 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

#### Secondary Outcomes

**Description:** 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).

**Measure:** 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

**Description:** 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).

**Measure:** 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

**Description:** 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).

**Measure:** 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

**Description:** 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).

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**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).

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** elena.tomba@unibo.it

**Name:** Elena Tomba

**Phone:** +390512091339

**Role:** CONTACT

**Contact 2:**

**Email:** sara.gostoli2@unibo.it

**Name:** Sara Gostoli

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bologna

**Contacts:**

***Contact 1:***

- **Email:** marialetizia.petroni@unibo.it

- **Name:** Maria Letizia Petroni

- **Role:** CONTACT

**Country:** Italy

**Facility:** IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** University of Bologna

**Name:** Elena Tomba

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** IRCCS Azienda Ospedaliero-Universitaria di Bologna

**Name:** Maria Letizia Petroni

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

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## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-11-21

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 388430

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-09T04:23

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Misc Info Module

- Version Holder: 2024-05-31
