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The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity
Sponsor: Catholic University of the Sacred Heart
Summary
Objective: This study aims to evaluate the feasibility and effectiveness of the OB-WELL program, an internet-based self-help intervention grounded in the principles of Cognitive Behavioral Therapy (CBT) and Brief Strategic Therapy (BST), designed to promote psychological well-being among individuals with obesity from the general Italian population. Methods: A three-arm randomized controlled trial with individual-level random allocation will be conducted to compare two active intervention formats - CBT and BST - with a waiting list (WL) control condition. The intervention will last six weeks and will consist of five online self-help modules followed by one individual synchronous session. Selected psychological outcomes will be assessed at baseline and immediately post-intervention (after 6 weeks). Participants in the experimental groups will also complete follow-up assessments at 3, 6, and 12 months after treatment termination. Expected results and conclusions: Both active interventions are expected to show greater improvements immediately post-treatment compared to the waitlist (WL) condition, and these effects are anticipated to be maintained over time. It is further hypothesized that the BST condition will demonstrate greater stability of psychological outcomes at follow-up compared to CBT.
Official title: The OB-WELL Project: Study Protocol for a Three-Arm Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2026-06-15
Completion Date
2027-06-30
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
BST Internet-based intervention
Participants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Brief Strategic Therapy (BST). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.
CBT Internet-based intervention
Participants allocated to the experimental group will be asked to complete one module per week, each based on the core principles of Cognitive Behavioral Therapy (CBT). The program comprises five structured online self-help modules, designed to address the following domains: (1) introduction to the intervention framework and definition of individualized objectives; (2) identification and restructuring of negative automatic thoughts; (3) recognition and regulation of emotions, with specific focus on emotional eating; (4) stress management and development of assertive communication skills; and (5) enhancement of motivation, problem-solving abilities, and self-efficacy. An additional synchronous video-meeting (Module 6) is conducted to consolidate acquired skills, support relapse prevention, and promote long-term maintenance of treatment gains.
Locations (1)
Catholic University of Sacred Heart
Milan, Italy, Italy