Acceptance and Commitment Therapy for adolescents with obesity
The ACTyourCHANGE Study Protocol: An ACT Based Inter-vention for Adolescents With Obesity: A Randomized Controlled Trial
This study is testing if adding a special therapy to regular weight loss treatment can help improve mental health for teenagers with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Verbania) |
| Trial ID | NCT04896372 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of a brief Acceptance and Commitment Therapy (ACT) intervention combined with treatment as usual (TAU) in improving psychological well-being among adolescents with obesity. Fifty adolescents aged 12-17 with a BMI above the 97th percentile will be recruited from a clinical center for obesity rehabilitation and randomly assigned to either the ACT + TAU group or the TAU only group. Both groups will participate in a three-week multidisciplinary rehabilitation program focused on weight loss, with the ACT group receiving additional psychological support based on ACT principles. The study aims to assess changes in psychological conditions pre- and post-intervention.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-17 with obesity, defined as a BMI greater than the 97th percentile for their age and sex.
Not a fit: Patients with physical problems or cognitive impairments that hinder participation in the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the psychological well-being of adolescents struggling with obesity.
How similar studies have performed: While there is growing interest in psychological interventions for obesity, this specific combination of ACT and standard care is relatively novel and has not been extensively tested in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * any physical problems or cognitive impairment that could compromise the participation in the study.
Where this trial is running
Verbania
- San Giuseppe Hospital, Istituto Auxologico Italiano IRCSS — Verbania, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.