Getting Back on Track: Alternative Healthcare Delivery Strategies to Prevent Weight Regain After Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in Body max index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomization is performed by a researcher not involved in data management. The researcher who evaluates the outcomes of interest is masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Underwent Roux-en-Y Gastric Bypass or Gastric Sleeve
- •Be at least 12 months after surgery;
- •Have a Facebook® account and regular Internet access.
排除标准
- •Under weight-loss medications;
- •Having acute psychiatric or medical problems;
- •pregnancy or lactation;
- •illiteracy.
结局指标
主要结局
Change in Body max index
时间窗: 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
Change in Disordered eating behaviors
时间窗: 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.
Change in Grazing behavior
时间窗: 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.
Change in Eating disorder psychopathology
时间窗: 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.
Change in Loss of control over eating
时间窗: 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.
Change in Difficulties in emotion regulation
时间窗: 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.
Change in Negative urgency
时间窗: 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.
Change in Psychological impairment
时间窗: 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.
次要结局
- 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).)
研究者
Eva Conceição
Professor, Principal Investigator
Universidade do Porto