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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS
RECRUITING
Verbania
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2024-03-31
Participants
Target number of participants: 50
Treatments
Experimental: ACT intervention
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: Standard care
The TAU comprises a three-week in-hospital multidisciplinary rehabilitation program for weight loss and the standard psychological assessment and support to the hospitalization
Related Therapeutic Areas
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov