Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery
NCT ID: NCT05946187
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
144 participants
INTERVENTIONAL
2022-05-01
2026-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Apolo_Bari Stepped-care intervention group
The Apolo\_Bari stepped-care intervention offers two different steps from low- to high-intensity strategies. The intervention will run for 18 months. All participants receive first step intervention. Patients will move through the second step according to the degree of disordered eating behaviors or weight regain which is assessed through a short Monthly Monitoring Questionnaire.
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.
Treatment as usual group
Treatment As Usual control group receives the standard intervention for bariatric surgery offered by multidisciplinary teams in Portuguese public hospitals. It consists of endocrinology, nutrition and surgery consultations, usually lasting 30 minutes every 6 months. These consultations usually include a physical exam (weight, height) and personalized diet/lifestyle recommendations. The Treatment as usual intervention is common to the Apolo\_Bari Steppped-care intervention group and the treatment as usual control groups.
Treatment as Usual for Bariatric Surgery
Treatment as Usual for bariatric surgery in portuguese public hospitals.
Interventions
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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.
Treatment as Usual for Bariatric Surgery
Treatment as Usual for bariatric surgery in portuguese public hospitals.
Eligibility Criteria
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Inclusion Criteria
* Be at least 12 months after surgery;
* Have a Facebook® account and regular Internet access.
Exclusion Criteria
* Having acute psychiatric or medical problems;
* pregnancy or lactation;
* illiteracy.
18 Years
65 Years
FEMALE
No
Sponsors
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Hospital de Braga
OTHER
Fundação para a Ciência e a Tecnologia
OTHER
Centro Hospitalar De São João, E.P.E.
OTHER
Universidade do Porto
OTHER
University of Minho
OTHER
Responsible Party
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Eva Conceição
Professor, Principal Investigator
Locations
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Centro Hospitalar Universitário do Porto
Porto, , Portugal
Countries
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Other Identifiers
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UMinho_ApoloBari_FB
Identifier Type: -
Identifier Source: org_study_id