Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

NCT05946187 | Active Not Recruiting

• 1 other identifier: UMinho_ApoloBari_FB
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

alternative healthcare strategies; weight regain; eating behaviors; bariatric surgery

Outcome Measures

Primary Outcomes (8)

• Change in Body max index

  Calculated by WHO guidelines

  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.

• Change in Disordered eating behaviors

  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 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.

• Change in Grazing behavior

  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 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.

• Change in Eating disorder psychopathology

  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 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.

• Change in Loss of control over eating

  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 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.

• Change in Difficulties in emotion regulation

  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 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.

• Change in Negative urgency

  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 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.

• Change in Psychological impairment

  Depression Anxiety Stress Scales (DASS) - measure that evaluates three dimensions: anxiety, depression, and stress. Higher scores indicate a higher presence of these problems.

  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.

Secondary Outcomes (2)

• Satisfaction with intervention

  Assessment at 18 months after the beginning of the intervention (End of treatment).

• Attendance to the intervention.

  Assessment at 18 months after the beginning of the intervention (End of treatment).

Study Arms (2)

Apolo_Bari Stepped-care intervention group

EXPERIMENTAL

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.

Behavioral: Apolo_Bari Stepped-care intervention

Treatment as usual group

ACTIVE COMPARATOR

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.

Other: Treatment as Usual for Bariatric Surgery

Interventions

Apolo_Bari Stepped-care intervention BEHAVIORAL

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.

Apolo_Bari Stepped-care intervention group

Treatment as Usual for Bariatric Surgery OTHER

Treatment as Usual for bariatric surgery in portuguese public hospitals.

Treatment as usual group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underwent Roux-en-Y Gastric Bypass or Gastric Sleeve
• Be at least 12 months after surgery;
• Have a Facebook® account and regular Internet access.

You may not qualify if:

• Under weight-loss medications;
• Having acute psychiatric or medical problems;
• pregnancy or lactation;
• illiteracy.

Sponsors & Collaborators

• University of Minho: lead
• Hospital de Braga: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator
• Universidade do Porto: collaborator

Study Sites (1)

Centro Hospitalar Universitário do Porto

Porto, Portugal

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Therapeutics; Bariatric Surgery

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization is performed by a researcher not involved in data management. The researcher who evaluates the outcomes of interest is masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Model Details: This randomized controlled trial will compare two groups: a Treatment As Usual control group with an Stepped-care intervention group. The Stepped-care approach organizes interventions with two different intensities (Steps 1-2), delivered entirely via private groups on Facebook®. A logarithm will guide when patients move to another step based on the presence of certain key symptoms. Participants will be recruited at the São João Hospital Center and at the Hospital of Braga. All participants will be contacted by the researcher after their medical appointment. Patients meeting the criteria will be invited to participate in the study and sign an informed consent form. Objectives and procedures of the investigation will be explained. The study will be introduced as a program to support bariatric patients in the long term in different modalities, which aims to monitor relevant variables and investigate patients' perceptions of the utility of these interventions.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 14, 2023
• Study Start: May 1, 2022
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

PT (1)