Clinical trial NCT05946187: Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery
Official title: Getting Back on Track: Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity Adult Onset
Eating Behavior
Keywords: alternative healthcare strategies
weight regain
eating behaviors
bariatric surgery
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital de Braga
name: Fundação para a Ciência e a Tecnologia
name: Centro Hospitalar De São João, E.P.E.
name: Universidade do Porto
First posted: 2023-07-14
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body max index
timeFrame: 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.
measure: Change in Disordered eating behaviors
timeFrame: 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.
measure: Change in Grazing behavior
timeFrame: 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.
measure: Change in Eating disorder psychopathology
timeFrame: 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.
measure: Change in Loss of control over eating
timeFrame: 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.
measure: Change in Difficulties in emotion regulation
timeFrame: 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.
measure: Change in Negative urgency
timeFrame: 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.
measure: Change in Psychological impairment
timeFrame: 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:
measure: Satisfaction with intervention
timeFrame: Assessment at 18 months after the beginning of the intervention (End of treatment).
measure: Attendance to the intervention.
timeFrame: Assessment at 18 months after the beginning of the intervention (End of treatment).
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar Universitário do Porto
Study officials:
References: