Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05946187
Study type Interventional
Source University of Minho
Contact
Status Active, not recruiting
Phase N/A
Start date May 1, 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Completed NCT03117374 - Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy N/A
Completed NCT04025099 - Internal Cues Versus External Cues for Eating and Activity N/A
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT05485168 - Combined Effects of Sequential Variety and Portion Size on Meal Intake of Women N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT03850990 - Effect of Gut-Cued Eating on BMI and Efficacy of Open-Label Placebo to Augment Weight Loss N/A
Completed NCT02470949 - Influence of a Monopoly Game on Subtle Behaviors N/A
Recruiting NCT01863212 - The Role of the FTO Gene in Reward System Activation in Obese and Healthy Subjects N/A
Completed NCT02729675 - Innovative Approaches to Increase F&V Intake Thru Worksites Phase 2
Completed NCT05405244 - Examination of Bromocriptine on Homeostatic and Hedonic Mechanisms of Food Intake in Individuals at High Risk for T2DM Phase 3
Completed NCT04971811 - Effects of Energy Density on Self-served Snacks in Preschool Children N/A
Completed NCT05019872 - Al Dente or Well Done? The Eating Rate of a Pasta Meal Modified by Texture N/A
Completed NCT04605224 - Effectiveness of a Culinary Class on Food Literacy and Eating Behaviours of Francophone High School Students
Not yet recruiting NCT06448117 - Mind Nutrition Study: Nutrition in the Prevention of Depressiveness and Sustaining Work Ability N/A
Recruiting NCT04526743 - Eating Behavior and Weight Trajectory After Bariatric Surgery
Active, not recruiting NCT05026411 - Food Reward Circuit Change by Orthodontics N/A
Completed NCT05173311 - Pilot Study: The Effectiveness of a Mobile Application in Increasing Vegetable Acceptance N/A
Completed NCT05149066 - #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents N/A
Completed NCT03779321 - Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects N/A
Recruiting NCT06108128 - Food for Thought: Executive Functioning Around Eating Among Children N/A