Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Bologna
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline in weight-loss
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Elena Tomba
Associate Professor
University of Bologna
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
- 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)
- 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)
- 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)
- 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)
- 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)