Promoting Positive Mental Health for Sustainable Eating Behaviors: the PROMISE Study in Patients With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in weight-loss
研究概览
简要总结
The main aim of the present study is to assess the effects and the effectiveness of a psychological intervention based on the principles of well-being therapy (WBT) in promoting weight-loss, sustainable and healthy eating behaviors and an optimal psychological functioning in patients with obesity.
详细描述
The primary objective of this pilot study is to assess the effects and the effectiveness, both post-treatment and at 1- and 3-month follow-ups, of a group intervention inspired by the principles of Well-Being Therapy (WBT), combined with a nutritional education, compared to treatment as usual (TAU), namely a Basic Nutritional Intervention (BNI) in a group setting, in terms of weight loss.
The secondary objective is to evaluate the effects and effectiveness of this intervention, both post-treatment and at 1- and 3-month follow-ups, compared to BNI, in promoting healthy and sustainable eating behaviors and an optimal psychological functioning. This includes the promotion of balanced psychological well-being levels and functional eating styles, and the reduction of both psychological distress and dysfunctional justification cognitive mechanisms use.
After being informed about the study and its potential risks, all patients giving written informed consent will be randomly assigned to either the experimental group or the control group. Both groups will participate in five weekly online group sessions of two hours each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are included in the study if they:
- •are affiliated with the Clinical Nutrition and Metabolism Unit of Policlinico S. Orsola-Malpighi;
- •have a BMI ≥ 30;
- •are aged ≥ 18 years;
- •voluntarily agree to participate in the study;
- •have access to a computer and can use it independently.
排除标准
- •Patients are excluded from the study if they:
- •do not sign the informed consent to participate in the study;
- •have limited knowledge of the Italian language;
- •have cognitive deficits;
- •meet the diagnostic criteria for one or more of the following psychiatric diagnoses: drug and/or alcohol abuse, psychotic disorders, neuro-cognitive disorders, suicidal behaviors;
- •participate in another weight loss study or program;
- •take weight loss medications;
- •engage in individual or group psychotherapeutic interventions;
- •have undergone weight loss surgery in the 16 months preceding the study and during the entire study period (approximately five months);
- •(only women) were/are pregnant or were/are planning pregnancy in the 16 months preceding the study and during the entire study period (approximately five months).
结局指标
主要结局
Change from baseline in weight-loss
时间窗: Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention
Body weight will be both self-evaluated by patients and will be verified by the medical staff during follow-up visits
次要结局
- Change from baseline in the Depression and Anxiety Stress Scale (DASS-21)(Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention)
- Change from baseline in the Dutch Eating Behavior Questionnaire (DEBQ)(Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention)
- Change from baseline in the Sustainable and Healthy Dietary Behaviors (SHDB) questionnaire(Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention)
- Change from baseline in the Psychological Well-Being Scale (PWBs)(Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention)
- Change from baseline in the use of dysfunctional cognitive justification mechanisms assessed through an ad-hoc form(Baseline, 35 days after starting the intervention, 1 month after finishing the intervention and 3 months after finishing the intervention)
研究者
Elena Tomba
Associate Professor
University of Bologna