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临床试验/NCT04896372
NCT04896372Unknown不适用

The ACTyourCHANGE Study Protocol: An ACT Based Inter-vention for Adolescents With Obesity: A Randomized Controlled Trial

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Psychological Well-Being

研究概览

简要总结

This Randomized Controlled Trial (RCT) aims to evaluate the effectiveness of a brief Acceptance and Commitment Therapy (ACT)-based-intervention combined with treatment as usual (TAU) compared to TAU only in improving psychological conditions in a sample of adolescents with obesity (body mass index, BMI > 97th centile for age and sex). Fifty consecutive adolescents (12-17 years) of both genders with obesity will be recruited among the patients hospitalized in a clinical center for obesity rehabilitation and randomly allocated into two experimental conditions: ACT + TAU vs TAU only. Both groups will attend a three-week in-hospital multidisciplinary rehabilitation program for weight loss. The ACT + TAU condition comprises a psychological intervention based on ACT combined with a standard psychological assessment and support to the hospitalization. The TAU comprises the standard psychological assessment and support to the hospitalization. At pre- to post-psychological intervention participants will complete the Avoidance and Fusion Questionnaire for Youth, the Psychological Well-Being Scale, the Depression Anxiety Stress Scale, the Difficulties in Emotion Regulation Scale, and the Emotional Eating subscale of the Dutch Eating Behavior Questionnaire. Repeated-measures ANOVAs (2x2) will be conducted. The study will assess the effectiveness of a brief ACT-based intervention for adolescents with obesity.

详细描述

Obesity in childhood and adolescence is becoming a major public health concern. In this respect, recent estimates pointed out that globally 124 million children and adolescents, aged between 5 and 19 years, were obese. In Europe, the prevalence of overweight and obese children and adolescents aged between 5 to 19 years is reported around 19%, with a higher prevalence in southern European countries.

Obesity in children and adolescents is associated with a higher risk of developing several physical and psychological problems that have an impact on their emotional development [3]. Research has reported associations between childhood and adolescent obesity and some form of psychopathology, as depression, anxiety, and attention-deficit/hyperactivity disorder. Besides, children and adolescents with obesity are more likely to suffer from psychosocial disadvantages as discrimination, social isolation, and bullying because of their weight. Moreover, obesity in childhood and adolescence is associated with poor body image, low self-esteem, and low quality of life and well-being.

This evidence suggests that obesity is a complex disease that may dramatically impair psychological health, representing a risk factor for children and adolescents' future development. This aspect calls for a better understanding of the associated risk factors and requires a multidisciplinary approach - entailing medical, nutritional, physical, and psychological components - aimed to address not only weight loss but also improving psychological conditions and treating obesity-related comorbidities.

The development of dysfunctional eating habits is one of the main factors linked to body weight, and it can be considered a barrier to weight loss [14,15]. Evidence from the literature suggests that unhealthy and dysfunctional eating habits could be related to a failure in emotional regulation strategies, that lead individuals to eat in response to difficult emotions, as in case of emotional eating defined as the tendency to eat in response of negative feelings.

Emotional regulation is defined as the ability to manage emotions, which means to recognize, understand, accept and modulate flexible responses to emotions. High emotion regulation allows individuals to act accordingly with personal goals, even in the presence of difficult emotions, while controlling for impulsive behaviors. On the contrary, when emotional regulation is lacking, emotional eating is undertaken to regulate difficult feelings.

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
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •BMI>97th centile according to age- and sex-specific Italian charts;
  • •Italian mother tongue
  • •written and informed consent to participate from both parents and written assent from participants

排除标准

  • •any physical problems or cognitive impairment that could compromise the participation in the study.

研究组 & 干预措施

ACT intervention

Experimental

The ACT condition (comprehensive of standard care) comprises a three-week in-hospital multidisciplinary rehabilitation program for weight loss and a psychological intervention based on ACT combined with a standard psychological assessment and support to the hospitalization.

干预措施: ACT comprehensive of standard care (Other)

Standard care

Other

The TAU comprises a three-week in-hospital multidisciplinary rehabilitation program for weight loss and the standard psychological assessment and support to the hospitalization

干预措施: TAU only (Other)

结局指标

主要结局

Psychological Well-Being

时间窗: Change from baseline baseline psychological well-being to 3 weeks

The Psychological Well-Being Scales (PWB) will be administered to assess psychological well-being. It is a self-report measure that explores six dimensions: self-acceptance, positive relationships with others, autonomy, environmental control, personal growth, and life purpose. The questionnaire consists of 18 items rated on a 4-point Likert scale ranging from 1 ("completely disagree") to 4 ("completely agree"). scre range from 18 to 72. Higher scores indicate higher well-being. The Italian version, assessed for Italian adolescents, is reported to have good psychometric properties (test-retest correlation coefficients: Self-acceptance: r = .82; Positive relationships: r = .81; Autonomy: r = .21; Environmental control: r = .31; Life purpose: r = .81; Personal growth: r = .78.).

次要结局

  • Experiential avoidance and fusion(Change from baseline baseline experiential avoidance and fusion to 3 weeks)
  • Emotional regulation(Change from baseline baseline emotional regulation to 3 weeks)
  • Emotional eating(Change from baseline baseline emotional eating to 3 weeks)
  • Psychological distress.(Change from baseline psychological distress to 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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The ACTyourCHANGE Study Protocol for Adolescents | 临床试验