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临床试验/NCT02850796
NCT02850796已完成不适用

Kg-Free: an Acceptance, Mindfulness and Compassionate-based Intervention for Women Struggling With Their Weight: A Randomized Controlled Trial

University of Coimbra0 个研究点目标入组 73 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
73
主要终点
Changes in eating behaviours

研究概览

简要总结

This study aims to test the efficacy and feasibility of an acceptance, mindfulness and compassionate-based intervention for women with overweight and obesity without binge-eating disorder (Kg-Free). Kg-Free intervention comprises 10 weekly group sessions plus 2 booster fortnightly sessions (31/2months) 2h30 hours each, run in small groups at Coimbra's University Hospital. The main goal of Kg-Free intervention is to reduce weight self-stigma and unhealthy eating behaviours and promote quality-of-life by targeting weight-related experiential avoidance and self-criticism patterns. The intervention focuses on fostering a greater awareness and ability to be in contact, tolerate and accept all internal experiences (even the unwanted ones, such as craving for food, fatigue, stigma and shame), rather than trying to avoid, control or change them. Additionally, the intervention intents for participant's to develop a compassionate attitude towards themselves, especially during challenging times in order to decrease shame and self-criticism.

详细描述

This project aims to develop and test the efficacy of an integrated intervention (Kg-FREE), based on different and complementary approaches from the 3rd generation therapies (Acceptance and commitment therapies - ACT, Mindfulness and Compassion Focused Therapy) that have been showing promising results individually, but that were never tested simultaneously in intervention for people struggling with their eating and weight. Moreover, the intervention aims to act specifically on patients' self-criticism and experiential avoidance patterns in order to reduce weight-self-stigma and promote healthy behaviours and quality-of-life. Indeed, several studies have been suggesting the crucial role of these emotional regulation processes on behavioural modification. This study will investigate the impact of the changes in several psychological processes in different obesity dimensions, such as body mass and biochemical parameters associated with health risks, eating behaviours, stigma, health and quality of life.

The Kg-FREE intervention encloses 10 weekly group sessions (2, 5 hours/ each), highly experiential followed by two 2 booster fortnightly sessions. The intervention is divided into several modules, that are applied in a structured way: a) psycho education related to eating and physical exercise healthy habits; b) how our brain works and how does this relate to our eating and weight; c) Life values identifications to enhance intrinsic motivation; d) cognitive fusion and experiential avoidance as maladaptive strategies that underlie the psychological suffering, the negative affect (e.g. shame) and self-criticism; e) mindfulness exercises as a more adaptive strategy for emotional regulation; f) development of self-compassion as an antidote for shame and self-criticism, activating the soothing system and deactivating the threat system.

Kg-Free sessions were carried out by a clinical psychologist with previous training in contextual-behavioral therapies and one clinical psychology master student. The intervention protocol was built upon pre-existent ACT and mindfulness-based protocols for people with eating and weight issues (e.g., Forman et al., 2013; Kristeller & Wolever, 2011; Lillis et al., 2009; Tapper et al., 2009). Additionally, and because it has been recognized the importance of integrating compassion in behavioural interventions (e.g., Luoma & Platt, 2015), specially to deal with shame and self-criticism (Gilbert, 2010) a compassion component was added. This component aimed at training participants to develop a more accepting and kind relationship with themselves, particularly when things go wrong or when facing errors or failures.

All session followed the same basic structure, starting with 30 minutes of shared experience, followed by a five-minute mindfulness practice. Then the session content was delivered, followed by an eating mindfulness practice to train the ability to pay attention to food and eating physical sensations. Finally, the session content was briefly revised and practices for the week were established (e.g., mindfulness or compassion exercises). A participants' manual was provided, which included the targeted constructs, examples and exercise sheets. Audio files were given to the participants to ensure the practice of mindfulness and compassion exercises between sessions. Moreover, a Portuguese therapist manual was also assembled and is available upon request.

Previously to data collection, ethical approval was obtained from Clinical Trials Unit from Coimbra's University Hospital. Participants were adult women, aged between 18 and 55 years old, with overweight or obesity (BMI ≥ 25) without binge-eating, enrolled in nutritional treatment for weight loss in primary care units and Hospitals from Coimbra's district, Portugal. Participants were recruited directly at the medical care units in the day of their appointment. Participants were informed about the voluntary and confidential nature of the data. Also, a brief overview of the treatment program was presented and participants were required to sign the informed consent. In order to assure confidentiality a numerical unique code was assigned to each participant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with overweight or obesity (BMI above 25);
  • Enrolled in nutritional treatment for weight loss in primary care units and Hospitals from Coimbra

排除标准

  • Binge Eating Disorder assessed through Eating Disorders Examination Interview;
  • Severe psychiatric problems (severe depressive episode, substance abuse, Bipolar disorder and Borderline Personality Disorder) assessed through Structured Clinical Interview for DSM Disorders (SCDI-I and SCID-II);
  • medical conditions that affect weight;
  • medication that can cause significant weight or appetite changes.

结局指标

主要结局

Changes in eating behaviours

时间窗: 9 months (from Baseline to 6-months follow-up)

Assessed by the Three Factor Eating Questionnaire (TFEQ-R21)

Changes in obesity-related quality-of-life

时间窗: 9 months (from Baseline to 6-months follow-up)

Assessed by Obesity Related Well-Being Questionnaire (ORWELL)

Changes in weight self-stigma

时间窗: 9 months (from Baseline to 6-months follow-up)

Assessed by Weight self-stigma questionnaire (WSSQ)

次要结局

  • Changes in BMI(9 months (from Baseline to 6-months follow-up))
  • Changes in Lipidic Profile (Total, HDL, LDL Cholesterol and Triglycerides)(9 months (from Baseline to 6-months follow-up))
  • Changes in Physical exercise frequency(9 months (from Baseline to 6-months follow-up))
  • Changes in psychopathological symptoms(9 months (from Baseline to 6-months follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lara Palmeira

Mcs

University of Coimbra

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