Examining the efficacy of a telehealth intervention targeting addictive eating in Australian adults (the TRACE Programme): a randomised controlled trial protocol.

INTRODUCTION: Approximately 15%-20% of the adult population self-report symptoms of addictive eating. There are currently limited options for management. Motivational interviewing-based interventions, containing personalised coping skills training, have been found to be effective for behaviour change in addictive disorders (eg, alcohol). This project builds upon foundations of an addictive eating feasibility study previously conducted and co-design process involving consumers. The primary aim of this study is to examine the efficacy of a telehealth intervention targeting addictive eating symptoms in Australian adults compared with passive intervention and control groups.

METHODS AND ANALYSIS: This three-arm randomised controlled trial will recruit participants 18-85 years, endorsing ≥3 symptoms on the Yale Food Addiction Scale (YFAS) 2.0, with body mass index >18.5 kg/m2 . Addictive eating symptoms are assessed at baseline (pre-intervention), 3 months (post-intervention) and 6 months. Other outcomes include dietary intake and quality, depression, anxiety, stress, quality of life, physical activity and sleep hygiene. Using a multicomponent clinician-led approach, the active intervention consists of five telehealth sessions (15-45 min each) delivered by a dietitian over 3 months. The intervention uses personalised feedback, skill-building exercises, reflective activities and goal setting. Participants are provided with a workbook and website access. The passive intervention group receives the intervention via a self-guided approach with access to the workbook and website (no telehealth). The control group receives personalised written dietary feedback at baseline and participants advised to follow their usual dietary pattern for 6 months. The control group will be offered the passive intervention after 6 months. The primary endpoint is YFAS symptom scores at 3 months. A cost-consequence analysis will determine intervention costs alongside mean change outcomes.

ETHICS AND DISSEMINATION: Human Research Ethics Committee of University of Newcastle, Australia provided approval (H-2021-0100). Findings will be disseminated via publication in peer-reviewed journals, conference presentations, community presentations and student theses.

TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry (ACTRN12621001079831).