Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery
NCT05946187 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2024-12-11
Summary
Bariatric surgery is the most effective treatment for severe obesity, yet a significant percentage of patients achieve suboptimal results or present long-term weight regain. Given the strong association between poor outcomes and post-surgery psychological factors, it is crucial to implement post-surgical psychological interventions.
This randomized controlled trial aims to compare the efficacy of a novel, cost-effective, and timely-personalized treatment delivering strategy (stepped-care) with two different intensities 1) low-intensity intervention delivered by Facebook®, and 2) high-intensity program delivered online. It is also intended to study predictors, outcome moderators/mediators, and the underlying mechanisms of weight regain. Participants' assessment will include measures of pathological eating behavior, psychological impairment, negative urgency, and emotional regulation.
Conditions
- Obesity Adult Onset
- Eating Behavior
Interventions
- BEHAVIORAL
-
Apolo_Bari Stepped-care intervention
Step 1 - Low-intensity intervention that will run on a private Facebook® group. Weekly, a subtopic and related activities are posted as short text/images. Patients are encouraged to participate by viewing publications, commenting, and posting their content. Step 2 - Will consist of an adjusted version of the Cognitive Behavior Treatment (CBT) program developed by Conceição et al. (2016). The intervention will last for 12-months and be delivered online by Facebook's functionalities, namely chat and calls. The intervention offered includes three components: 1) a psychoeducational cognitive-behavioral-based self-help manual that consists of 12 different modules. Each month a different topic will be covered and divided into four weekly sub-topics, which are supported with a set of related CBT tasks; 2) interactive call sessions with a psychologist (30 min at the beginning of each month); 3) monthly monitoring of risk-behaviors responded every session.
- OTHER
-
Treatment as Usual for Bariatric Surgery
Treatment as Usual for bariatric surgery in portuguese public hospitals.
Sponsors & Collaborators
-
Hospital de Braga
collaborator OTHER -
Fundação para a Ciência e a Tecnologia
collaborator OTHER -
Centro Hospitalar De São João, E.P.E.
collaborator OTHER -
Universidade do Porto
collaborator OTHER -
University of Minho
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-01
- Primary Completion
- 2024-11-30
- Completion
- 2026-12-31
Countries
- Portugal
Study Locations
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