Is intensive behavioural change enhanced with dialectical behavioural therapy feasible for weight management in adolescents living with higher body weight? A protocol for a pilot randomised controlled trial in three centres in Canada.

introductionFor adolescents living with higher body weight, changing lifestyle behaviours can be met with challenges due to psychosocial factors, such as mental health and emotional challenges. Few behavioural interventions have included skill development to manage these mental health and emotional challenges. METHODS AND ANALYSIS: The feasibility of a dialectical behavioural therapy (DBT)-enhanced lifestyle intervention will be evaluated through a pilot randomised controlled trial. We will recruit 90 adolescents aged 14-17 years with a body mass index Z-score >1.4 and mild-to-moderate depressive symptoms to participate with a caregiver in the trial. Adolescents will be randomised 2:2:1 to one of the three study arms: (A) behavioural lifestyle intervention with DBT skills training, (B) behavioural lifestyle intervention alone (ie, without DBT skills training) or (C) control. The interventions will include two sessions weekly for 16 weeks that include (1) one modified DBT skills training with two facilitators, supervised by a clinical psychologist, combined with one behavioural lifestyle session delivered by a dietitian and/or a kinesiologist and (2) two behavioural lifestyle sessions alone. DBT skills training will consist of teaching mindfulness, emotion regulation, distress tolerance, interpersonal effectiveness and walking the middle path modules. Behavioural sessions will be guided by evidence-based practices for goal setting, dietary counselling, improving sleep, reducing screen time and structured physical activity. The main outcomes are enrolment rates, adherence to the intervention and retention rates for follow-up measurements. The secondary outcome will be changes in the quality of life (Pediatric Quality of Life Inventory) and daily physical activity levels between baseline and immediately post-intervention. Adolescents will participate in a focus group incorporating photo elicitation to explore satisfaction, acceptability and perceived benefits of the study arms. ETHICS AND DISSEMINATION: This study has received ethical approval from the University of Manitoba's Biomedical Research Ethics Committee (HS24295-H2020:427), Hamilton Health Sciences & McMaster University (HiREB 18159) and The Conjoint Health Research Ethics Board (CHREB), University of Calgary (REB24-1084). Results will be disseminated through publication in peer-reviewed journals and be relevant to researchers and clinicians involved in paediatrics and paediatric weight management. TRIAL REGISTRATION NUMBER: NCT05338944.