NCT07476599Not yet recruiting
The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Obesity
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 224 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 15 Jan 2027
- Lead sponsor
- Catholic University of the Sacred Heart
- Diseases
- Obesity
- NCT number
- NCT07476599
What you commit to
- Study type: Interventional
- Planned participants: 224
- From 15 Jun 2026 to the primary completion date, 15 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent psychopharmacological treatment or ongoing psychological/psychotherapeutic intervention during the study period.
Other illness
- Diagnosis of severe psychiatric disorders according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
Other
- Visual, auditory, or cognitive impairments that could limit effective interaction with the digital interface;
- Insufficient digital literacy or lack of stable internet connectivity;
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Catholic University of Sacred Heart Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.