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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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.
IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,
Bologna, Italy
RECRUITINGChange from baseline in weight-loss
Body weight will be both self-evaluated by patients and will be verified by the medical staff during follow-up visits
Time frame: 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
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).
Time frame: 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)
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).
Time frame: 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)
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).
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Time frame: 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)
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).
Time frame: 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 use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form
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.
Time frame: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention