NCT05946187

Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

Getting Back on Track: Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: University of Minho · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research project intends to examine the effectiveness of a Cognitive Behavioral Therapy and psychoeducational based stepped-care program delivered online for patients submitted to bariatric surgery: APOLO\_Bari. Therefore, a randomized controlled trial will compare a control group receiving multidisciplinary medical treatment as usual (TAU) for bariatric surgery in public health care centers in Portugal, and an intervention group receiving TAU plus the stepped-care APOLO-Bari web-based intervention. The stepped-care APOLO-Bari intervention was designed to optimize weight loss, and prevent weight regain after bariatric intervention, promoting the adoption of healthy eating habits and lifestyle behaviors. All participants will be assessed at baseline, 6- and 12- months after the beginning of the intervention, at the end of the 18-months intervention and at 6-months follow-up. Additionally, throughout the entire intervention, patients will respond to a short monthly monitoring questionnaire (MMQ) which consist of a self-monitoring online tool that allows patients to regularly input monitoring information regarding key disordered eating behaviors and their weight, maintaining a log of the individual process. Based on this information, a decision rule will be used to move patients through the different levels of interventions: Step 1: all patients receive intervention; Step 2: patients reporting at least one disordered eating behavior (e.g. grazing, binge-eating, skipping meals), or 2kg weight regain since the beginning of the intervention. If/when a patient moves to a new step of the protocol, the same set of measures will be responded before, in the middle, and at the end of that intervention. ANOVAS for repeated measures and General Estimating Equations will be used to explore the differences between the groups in the various moments of evaluation. Hierarchical Linear Models with growth curves for repeated measurements will be used to explore the weight trajectories of patients in the two groups and to test predictors of weight variations. The PROCESS macro for SPSS will test moderators/mediators of the relationship between psychological variables, disordered eating behaviors, and weight loss.

Conditions

• Obesity Adult Onset
• Eating Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-11-30
• Completion: 2026-12-01
• First posted: 2023-07-14
• Last updated: 2024-12-11

Locations

1 site across 1 country: Portugal