ACTyourCHANGE Study Protocol. Promoting Healthy Lifestyle With ACT for Obesity

NCT04474509 | Recruiting

• 1 other identifier: 03C024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Behavior

Keywords

Acceptance and Commitment Therapy (ACT); Focused-Acceptance and Commitment Therapy (FACT); Obesity; Psychological flexibility; Cognitive Behavioral Therapy (CBT)

Outcome Measures

Primary Outcomes (3)

• Change in Weight

  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)

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Change in Psychological Well-Being

  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.

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Change in Psychological Treatment

  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)

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

Secondary Outcomes (6)

• Values

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Committed Actions

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Cognitive Fusion

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Acceptance

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

• Awareness

  Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)

Study Arms (3)

FACT Module Engagement

EXPERIMENTAL

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

FACT Module Openness

EXPERIMENTAL

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

FACT Module Awareness

EXPERIMENTAL

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

Interventions

FACT Module Engagement BEHAVIORAL

Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

FACT Module Engagement

FACT Module Openness BEHAVIORAL

Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

FACT Module Openness

FACT Module Awareness BEHAVIORAL

Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)

FACT Module Awareness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS

Verbania, 28921, Italy

RECRUITING

Related Publications (5)

• Fairburn CG, Rothwell ER. Apps and eating disorders: A systematic clinical appraisal. Int J Eat Disord. 2015 Nov;48(7):1038-46. doi: 10.1002/eat.22398. Epub 2015 Feb 27.

  PMID: 25728705 BACKGROUND

• Cattivelli R, Pietrabissa G, Ceccarini M, Spatola CA, Villa V, Caretti A, Gatti A, Manzoni GM, Castelnuovo G. ACTonFOOD: opportunities of ACT to address food addiction. Front Psychol. 2015 Apr 9;6:396. doi: 10.3389/fpsyg.2015.00396. eCollection 2015. No abstract available.

  PMID: 25914662 BACKGROUND

• Villatte JL, Vilardaga R, Villatte M, Plumb Vilardaga JC, Atkins DC, Hayes SC. Acceptance and Commitment Therapy modules: Differential impact on treatment processes and outcomes. Behav Res Ther. 2016 Feb;77:52-61. doi: 10.1016/j.brat.2015.12.001. Epub 2015 Dec 10.

  PMID: 26716932 RESULT

• Forman EM, Butryn ML, Manasse SM, Crosby RD, Goldstein SP, Wyckoff EP, Thomas JG. Acceptance-based versus standard behavioral treatment for obesity: Results from the mind your health randomized controlled trial. Obesity (Silver Spring). 2016 Oct;24(10):2050-6. doi: 10.1002/oby.21601.

  PMID: 27670400 RESULT

• Guerrini Usubini A, Cattivelli R, Giusti EM, Riboni FV, Varallo G, Pietrabissa G, Manzoni GM, Consoli S, Bastoni I, Granese V, Volpi C, Villa V, Caretti A, Bottacchi M, Castelnuovo G, Molinari E. The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy-a randomized controlled trial. Trials. 2021 Apr 20;22(1):290. doi: 10.1186/s13063-021-05191-y.

  PMID: 33879183 DERIVED

MeSH Terms

Conditions

Health Behavior; Obesity

Condition Hierarchy (Ancestors)

Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-arm Individually Randomized Group Treatment Trial

Study Record Dates

• First Submitted: July 4, 2020
• First Posted: July 16, 2020
• Study Start: February 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)