Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Body max index — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Calculated by WHO guidelines
• Change in Disordered eating behaviors — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Questionnaire developed for this study to evaluate the presence of key disordered eating behaviors (LOCE, binge-eating, grazing, and skipping meals). Higher scores indicate a higher presence of these problems.
• Change in Grazing behavior — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Repetitive Eating Questionnaire (Repeat-Q) - measure that assesses feelings, behaviors, and cognitions related to episodes of grazing resulting in two subscales: compulsive, and non-compulsive grazing. Higher scores indicate a higher presence of these problems.
• Change in Eating disorder psychopathology — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Eating Disorder\_15 (ED-15) - measure that evaluates eating disorder psychopathology with subscales for weight and shape concerns and for eating concerns. Higher scores indicate a higher presence of these problems.
• Change in Loss of control over eating — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  The Loss of Control over Eating Scale (LOCES) - measure that assesses the degree of LOC over eating in three aspects: behavioral, cognitive/dissociative and positive/euphoric. Higher scores indicate a higher presence of these problems.
• Change in Difficulties in emotion regulation — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Difficulties in Emotion Regulation Scale (DERS) - measure that assesses clinically relevant difficulties in emotion regulation through six dimensions: nonacceptance of emotional responses, difficulties engaging in goal-directed behavior when distressed, impulse control difficulties, lack of emotional awareness, limited access to effective emotion regulation strategies, and lack of emotional clarity. Higher scores indicate a higher presence of these problems.
• Change in Negative urgency — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  UPPS-NU: Measure that assesses an individual's tendency to surrender to strong impulses, particularly under situations of negative emotions. Higher scores indicate a higher presence of these problems.
• Change in Psychological impairment — Change from Baseline (before the intervention), to 6-,12-, and 18-months (end of treatment) after baseline, and 6 months after end of treatment. Specific duration of time over which participant is assessed: 24 months.
  Depression Anxiety Stress Scales (DASS) - measure that evaluates three dimensions: anxiety, depression, and stress. Higher scores indicate a higher presence of these problems.

Trial sites (1)

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