The ACTyourCHANGE Study Protocol for Adolescents

NCT04896372 | Recruiting

• 1 other identifier: 03C121
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Well-being

Outcome Measures

Primary Outcomes (1)

• Psychological Well-Being

  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.).

  Change from baseline baseline psychological well-being to 3 weeks

Secondary Outcomes (4)

• Experiential avoidance and fusion

  Change from baseline baseline experiential avoidance and fusion to 3 weeks

• Psychological distress.

  Change from baseline psychological distress 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

Study Arms (2)

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.

Other: ACT comprehensive of standard care

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

Other: TAU only

Interventions

ACT comprehensive of standard care OTHER

The proposed intervention was designed by the authors of the study. It was developed following the main ACT-based manuals, with adjustments according to the users and the context of the study implementation. Specifically, we developed a practical and interactive intervention, which comprises practical activities such as roleplay and writing activities and imaginative activities supported by metaphors. The sessions are based on the use of age-appropriate language to convey the most complex therapeutic processes easily. According to Strosahl and colleagues' model, sessions will respectively target the components of openness, awareness, and engagement.

ACT intervention

TAU only OTHER

adolescents will be assessed by a staff dietician and placed on an individualized hy-pocaloric balanced Mediterranean diet. They will also follow a nutritional counselling aimed at promoting the adoption of a healthy lifestyle. Moreover, they will attend a physical activity program consisting of five training sessions per week lasting one hour each with trainers; In addition, they will be involved in psychological counselling pro-vided once a week by a clinical psychologist, aimed to address psychological factors related to dysfunctional lifestyle habits.

Standard care

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

• NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in body-mass index, underweight, overweight, and obesity from 1975 to 2016: a pooled analysis of 2416 population-based measurement studies in 128.9 million children, adolescents, and adults. Lancet. 2017 Dec 16;390(10113):2627-2642. doi: 10.1016/S0140-6736(17)32129-3. Epub 2017 Oct 10.

  PMID: 29029897 BACKGROUND

• Sagar R, Gupta T. Psychological Aspects of Obesity in Children and Adolescents. Indian J Pediatr. 2018 Jul;85(7):554-559. doi: 10.1007/s12098-017-2539-2. Epub 2017 Nov 18.

  PMID: 29150753 BACKGROUND

• Giusti EM, Spatola CA, Brunani A, Kumbhare D, Oral A, Ilieva E, Kiekens C, Pietrabissa G, Manzoni GM, Imamura M, Castelnuovo G, Capodaglio P. ISPRM/ESPRM guidelines on Physical and Rehabilitation Medicine professional practice for adults with obesity and related comorbidities. Eur J Phys Rehabil Med. 2020 Aug;56(4):496-507. doi: 10.23736/S1973-9087.20.06232-2. Epub 2020 Apr 15.

  PMID: 32293813 BACKGROUND

• Sainsbury K, Evans EH, Pedersen S, Marques MM, Teixeira PJ, Lahteenmaki L, Stubbs RJ, Heitmann BL, Sniehotta FF. Attribution of weight regain to emotional reasons amongst European adults with overweight and obesity who regained weight following a weight loss attempt. Eat Weight Disord. 2019 Apr;24(2):351-361. doi: 10.1007/s40519-018-0487-0. Epub 2018 Feb 16.

  PMID: 29453590 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

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: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)