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NCT Number: NCT05946187

Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity Adult Onset Behavior Behavior, Animal Eating Behavior Feeding Behavior

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitário do Porto

Porto, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Treatment as Usual for Bariatric Surgery

Other

Treatment as Usual for bariatric surgery in portuguese public hospitals.

Primary outcomes

  1. Change in Body max index

    Time frame: 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

  2. Change in Disordered eating behaviors

    Time frame: 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.

  3. Change in Grazing behavior

    Time frame: 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.

  4. Change in Eating disorder psychopathology

    Time frame: 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.

  5. Change in Loss of control over eating

    Time frame: 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.

  6. Change in Difficulties in emotion regulation

    Time frame: 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.

  7. Change in Negative urgency

    Time frame: 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.

  8. Change in Psychological impairment

    Time frame: 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.

Secondary outcomes

  1. Satisfaction with intervention

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

    Satisfaction questionnaire - measure developed to this study to addresses the utility and feasibility of the program from the patient's perspective. Higher scores indicate a higher satisfation with the program.

  2. Attendance to the intervention.

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

    Number of interactions on Facebook® private group, number of sessions attended, and number of monthly monitoring questionnaires responded.

Sponsors and collaborators

Lead sponsor

University of Minho

Other

Collaborators

  • Centro Hospitalar De São João, E.P.E.
  • Fundação para a Ciência e a Tecnologia
  • Hospital de Braga
  • Universidade do Porto

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 14, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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