Obesity
Conditions
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.
Interventions
OTHERPsychological 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.
OTHERBasic 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.
Sponsors
University of Bologna
IRCCS Azienda Ospedaliero-Universitaria di Bologna
European Union
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in weight-loss | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire | 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). |
| Change from baseline in the Psychological Well-Being Scale (PWBs) | 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). |
| Change from baseline in the Dutch Eating Behavior Questionnaire (DEBQ) | 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). |
| Change from baseline in the Depression and Anxiety Stress Scale (DASS-21) | 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). |
| Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form | 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. |
Countries
Italy
Contacts
STUDY_DIRECTORElena Tomba
University of Bologna
PRINCIPAL_INVESTIGATORMaria Letizia Petroni
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Outcome results
None listed