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

Starting soon · Not applicable

Conditions studied: Obesity (BMI > 35)

In brief

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.

Key facts

Study ID

NCT07476599

Run by

Catholic University of the Sacred Heart

People needed

224

Starts

2026-06-15

Expected to finish

2027-06-30

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• Provision of informed consent via the digital platform;
• Presence of mild or subthreshold psychological or eating-related symptoms, as identified by the Web Screening Questionnaire (WSQ);
• Presence of a score < 27 on the Binge Eating Scale (BES).

You may not qualify if…

• 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.

Where it is running

• Catholic University of Sacred Heart — Milan, Italy, Italy

Full record on ClinicalTrials.gov

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