Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery

Eating Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05946187
• Other study ID #: UMinho_ApoloBari_FB
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 2026

Study information

• Verified date: July 2023
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• underwent Roux-en-Y Gastric Bypass or Gastric Sleeve for at least 12 months; (3) have a Facebook® account and regular Internet access.

Exclusion Criteria:

• under weight-loss medications; (2) acute psychiatric or medical problems; (3) pregnancy or lactation; (4) illiteracy;

Related Conditions & MeSH terms

• Eating Behavior
• Obesity Adult Onset

Intervention

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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar Universitário do Porto	Porto

Sponsors (4)

Lead Sponsor	Collaborator
University of Minho	Centro Hospitalar De São João, E.P.E., Fundação para a Ciência e a Tecnologia, Hospital de Braga

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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)	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.
Primary	Change in Grazing behavior	Repetitive Eating Questionnaire - measure that assesses feelings, behaviors, and cognitions related to episodes of grazing resulting in two subscales: compulsive, and non-compulsive grazing.	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.
Primary	Change in Eating disorder psychopathology	Eating Disorder_15 - measure that evaluates eating disorder psychopathology with subscales for weight and shape concerns and for eating concerns.	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.
Primary	Change in Loss of control over eating	The Loss of Control over Eating Scale - measure that assesses the degree of LOC over eating in three aspects: behavioral, cognitive/dissociative and positive/euphoric	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.
Primary	Change in Difficulties in emotion regulation	Difficulties in Emotion Regulation Scale - 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.	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.
Primary	Change in Negative urgency	Measure that assesses an individual's tendency to surrender to strong impulses, particularly under situations of negative emotions.	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.
Primary	Change in Psychological impairment	Depression Anxiety Stress Scales - measure that evaluates three dimensions: anxiety, depression, and stress.	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	Satisfaction with intervention	Satisfaction questionnaire - measure developed to this study to addresses the utility and feasibility of the program from the patient's perspective.	Assessment at 18 months after the beginning of the intervention (End of treatment).
Secondary	Attendance to the intervention.	Number of interactions on Facebook® private group, number of sessions attended, and number of monthly monitoring questionnaires responded.	Assessment at 18 months after the beginning of the intervention (End of treatment).