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ACTyourCHANGE Study Protocol. Promoting Healthy Lifestyle With ACT for Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04474509
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : March 11, 2021
Information provided by (Responsible Party):
Gianluca Castelnuovo, Istituto Auxologico Italiano

Brief Summary:

Background: as treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes.

Methods: a randomized controlled trial will be conducted. 90 Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thought, feelings, and behaviors at every moment. Weight, BMI (Kg/m2), the Psychological General Well Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion regulation scale (DERS) the Dutch eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), and the Five Facet Mindfulness Questionnaire (FFMQ) and the Acceptance and Action Questionnaire (AAQ II) will be assessed at the beginning (Time 0), at the end of psychological intervention (Time 1), after 3 (Time 2) and 6 months (Time 3) and 9 months (Time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device.

To assess the effectiveness of intervention, mixed between-withing 3 (conditions) x 4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3 and 4 in means of weight, BMI, and means scores PGWBI, OQ-45.2, DASS; DERS; DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups Discussion: This study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle.

Condition or disease Intervention/treatment Phase
Health Behavior Behavioral: FACT Module Engagement Behavioral: FACT Module Openness Behavioral: FACT Module Awareness Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-arm Individually Randomized Group Treatment Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The ACTyourCHANGE Study Protocol. Promoting a Healthy Lifestyle in Patients With Obesity With Acceptance and Commitment Therapy. A Randomized Controlled Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: FACT Module Engagement
During this module, patients will have the opportunity to increase their motivation to change and encourage the engagement in committed actions, consistent with their life values. Patients are invited to reflect on what is important in their lives, which values make their life worth living, and which actions they could take to live a meaningful life, in accordance with personal values. The use of metaphors and experiential exercises will facilitate the process of exploring personal values, identifying life directions and related behaviors. For example, the 80th Birthday Party metaphor requires participants to imagine there is a party in honor of their birthday and the time comes when people are starting to give speeches and try to answer the question about what they want to hear people at the party say. This exercise help patients in wondering what person they want to be with themselves and others.
Behavioral: FACT Module Engagement
Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

Experimental: FACT Module Openness

Participants attending this module are guided to recognize and distancing themselves to stressful thoughts, feelings and sensations. They will learn to read suffering as part of human experience, without self-judgment and self-condemnation. Rather, therapist will encourage the patient's assumption of an open and acceptable approach to internal experiences. Throughout the module, therapist will help patients to reflect on their usual, but ineffective efforts to solve personal problems, and encourage the adoption of new responsive strategies based on acceptance and defusion from personal distress.

An example of metaphor used during the Module is The Passenger on a bus. In this metaphor patient have to imagine to be a driver bus and his every thought is a passenger that gets on and off the bus. This exercise help patients to accept, defuse from, and reduce the power of their thoughts.

Behavioral: FACT Module Openness
Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

Experimental: FACT Module Awareness
The module comprises meditation exercises and experiences aimed to learn how to act intentionally with awareness about personal thought and sensations without automatically reacting. Participants are supported to recognize their actions and the context where they occur and learn to choose to respond with action consistent with their values and not automatically. Therapist will propose breathing exercises, body scan and others mindfulness experiences. Participants will be encouraged to sitting comfortably, close the eyes, feel themselves in contact with the present moment they are living, paying attention to their breath, noticing the rhythm and any other aspect of the experience of breathing. Then, the therapist guides the participant's attention on the body, noting any part of their body from the head to feet. Then, the sounds around, any noises that could distract their attention on themselves.
Behavioral: FACT Module Awareness
Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

Primary Outcome Measures :
  1. Change in Weight [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The primary outcome of the study is weight loss maintenance. Weight, and height will be assessed to calculate Body Mass Index (BMI= kg/m2). Weight loss maintenance will be assessed considering the difference between initial weight and weight recorded at follow-up. Success in long term weight loss maintenance is achieved if individual loss at list 10% of initial weight, and maintains weight lost for one year (R. R Wing & Hill, 2001)

  2. Change in Psychological Well-Being [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The second outcome measure is psychological well-being. The Psychological General Well-Being Inventory (PGWBI; (Dupuy, 1984) Italian validation of Grossi and colleagues (Grossi et al., 2006) consist of 22 self-administered items rated on a 6-point Likert scale, relative to six subscales that offer a measure of the level of subjective psychological well-being. Subscales are anxiety, depression, positive well-being, self-control, general health, and vitality with a range of Alpha's scores from 0.61 to 0.85 for each subscale.

  3. Change in Psychological Treatment [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The third outcome measure is the outcome of psychological treatment. The Outcome Questionnaire-45.2 (Lambert, Gregersen, & Burlingame, 2004) Italian version by Chiappelli, Coco, Gullo, Bensi, e Prestano (2008) as a measure for the assessment of psychological treatment is a self-report questionnaire composed by 45 items. Subscales are symptoms distress, interpersonal relations and social role functioning. Total Alpha score is excellent (.90 for clinical sample; .92 for non-clinical sample)

Secondary Outcome Measures :
  1. Values [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The Brief Values Inventory (McCracken & Yang, 2006) Italian validation of Baroni, McCracken, Matera, Nerini, & Stefanile ( 2019). It is composed by 12 items aimed to assess the success in living according to personal values. The internal consistency of the Success subscale is .70 in the Italian validation study.

  2. Committed Actions [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The Committed Action Questionnaire (McCracken, 2013) Italian adaptation of Baroni, Matera, Nerini, & Stefanile ( 2017) is 8-items self-report questionnaire rated on 7-point Likert scale, used to assess positive and negative aspects of the ability to engage themselves into committed actions driven by values. The internal consistency of the measure tested on a normative sample was good (α= .80).

  3. Cognitive Fusion [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The Italian-Cognitive Fusion Questionnaire (Gillanders et al., 2014) Italian version by Oppo and colleagues (2019) is 7-items questionnaire administered for the assessment of cognitive fusion. The internal consistency of the Italian version is excellent (α= .82).

  4. Acceptance [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The subscale "Nonjudge" of the Five Facet Mindfulness Questionnaire, described below, is used as a measure of Acceptance. The internal consistency of the subscale is .86

  5. Awareness [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The Five Facet Mindfulness Questionnaire (FFMQ; (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). The Italian version (Boffito et al., 2009) is 39-item-self-report questionnaire used as a measure of Mindfulness. It is composed by five subscales: observe, describe, act with awareness, non-react, nonjudge. The internal consistency of total scale is good (α .86).

  6. Psychological inflexibility and experiential avoidance [ Time Frame: Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3) ]
    The Acceptance and Action Questionnaire (AAQ II: (Bond et al., 2011). The Italian version (Pennato, Berrocal, Bernini, & Rivas, 2013) is the most widely used self-reported questionnaire that measures psychological inflexibility and experiential avoidance. It is composed by 10 items, rated on 7-point Likert scale, the Internal consistency is good (α .83) and test-retest reliability is moderate (.61)

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • BMI>30;
  • Written and informed consent to participate; 4) being technology friendly to use wearable devices.

Exclusion Criteria:

  • other psychiatric disturbances (diagnosed according to DSM 5 criteria);
  • other medical conditions not related to obesity that could compromise participation at the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04474509

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San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS Recruiting
Verbania, Italy, 28921
Contact: Gian Luca Castelnuovo, Ph.D.    0039323514338   
Contact: Roberto Cattivelli, Ph.D.    0039323514246   
Sub-Investigator: Roberto Cattivelli, Psy.D.         
Sub-Investigator: Anna Guerrini Usubini, MD         
Sponsors and Collaborators
Istituto Auxologico Italiano
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gianluca Castelnuovo, Professor, Istituto Auxologico Italiano Identifier: NCT04474509    
Other Study ID Numbers: ACTyourCHANGE
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gianluca Castelnuovo, Istituto Auxologico Italiano:
Acceptance and Commitment Therapy (ACT)
Focused-Acceptance and Commitment Therapy (FACT)
Psychological flexibility
Cognitive Behavioral Therapy (CBT)
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight