The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCatholic University of the Sacred Heart

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18 years or older;

Body Mass Index (BMI) ≥ 30 kg/m²; 3. Internet access;

Sufficient computer and internet literacy;

Fluent knowledge of the Italian language;

Disqualifiers

Visual, auditory, or cognitive impairments that could limit effective interaction with the digital interface;

Diagnosis of severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);

Insufficient digital literacy or lack of stable internet connectivity;

Concurrent psychopharmacological treatment or ongoing psychological/psychotherapeutic intervention during the study period.

Trial design

Treatments tested in this trial

  • BST Internet-based intervention
  • CBT Internet-based intervention

Treatment groups

224 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Catholic University of the Sacred Heart

Lead sponsor

Linkoeping University

Collaborator

Istituto Auxologico Italiano

Collaborator