Promoting Positive Mental Health for Sustainable Eating Behaviors
- Conditions
- Obesity
- Interventions
- Other: Basic Nutritional InterventionOther: Psychological intervention based on WBT and cognitive restructuring
- Registration Number
- NCT06416215
- Lead Sponsor
- University of Bologna
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Basic Nutritional Intervention Basic Nutritional Intervention Six weekly online sessions of two hours of a nutritional education. Psychological intervention based on WBT and cognitive restructuring 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 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.
Trial Locations
- Locations (1)
IRCCS-S. Orsola-Malpighi Hospital, University of Bologna,
🇮🇹Bologna, Italy