A two arm randomized controlled trial comparing the short and long term effects of an elimination diet and a healthy diet in children with ADHD (TRACE study). Rationale, study design and methods
BMC Psychiatry, vol. 20, pp. 262
Abstract
BACKGROUND: Food may trigger Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. Therefore, an elimination diet (ED) might be an effective treatment for children with ADHD. However, earlier studies were criticized for the nature of the control group, potential confounders explaining the observed effects, unsatisfactory blinding, potential risks of nutritional deficiencies and unknown long term and cost-effectiveness. To address these issues, this paper describes the rationale, study design and methods of an ongoing two arm randomized controlled trial (RCT) comparing the short (5 week) and long term (1 year) effects of an elimination diet and a healthy diet compared with care as usual (CAU) in children with ADHD. METHODS: A total of N = 162 children (5-12 years) with ADHD will be randomized to either an ED or a healthy diet. A comparator arm including N = 60 children being solely treated with CAU (e.g. medication) is used to compare the effects found in both dietary groups. The two armed RCT is performed in two youth psychiatry centers in the Netherlands, with randomization within each participating center. The primary outcome measure is response to treatment defined as a ≥ 30% reduction on an ADHD DSM-5 rating scale (SWAN) and/or on an emotion dysregulation rating scale (SDQ: dysregulation profile). This is assessed after 5 weeks of dietary treatment, after which participants continue the diet or not. Secondary outcome measures include the Disruptive Behavior Diagnostic Observational Schedule (DB-DOS), parent and teacher ratings of comorbid symptoms, cognitive assessment (e.g. executive functions), school functioning, physical measurements (e.g. weight), motor activity, sleep pattern, food consumption, nutritional quality of the diet, adherence, parental wellbeing, use of health care resources and cost-effectiveness. Assessments take place at the start of the study (T0), after five weeks (T1), four months (T2), eight months (T3) and 12 months of treatment (T4). T0, T1 and T4 assessments take place at one of the psychiatric centers. T2 and T3 assessments consist of filling out online questionnaires by the parents only. DISCUSSION: This RCT will likely contribute significantly to clinical practice for ADHD by offering insight into the feasibility, nutritional quality, (cost-)effectiveness and long term effects of dietary treatments for ADHD. TRIAL REGISTRATION: www.trialregister.nl, NTR5434. Registered at October 11th, 2015.
Authors 22
-
Annick Bosch corresponding
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands. a.bosch@karakter.com
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Utrecht University · University Medical Center Utrecht · National Institute for Public Health and the Environment
Affiliation as printed
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands
-
Affiliation as printed
Leiden University, Institute of Psychology and Leiden Institute for Brain and Cognition, Leiden, The Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Affiliation as printed
Accare, Child and Adolescent Psychiatry, Groningen, the Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Affiliation as printed
Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands
-
Huf Hülsbeck & Fürst (Germany)
Affiliation as printed
Freelance dietician, Velp, the Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Affiliation as printed
De Bascule, Center for Child and Adolescent Psychiatry, Amsterdam, The Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Radboud University Nijmegen · Radboud University Medical Center · Amalia Kinderziekenhuis
Affiliation as printed
Department of Pediatrics, Radboud University Medical Center Amalia Children's hospital, Nijmegen, the Netherlands
-
Radboud University Medical Center
Affiliation as printed
Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
University Medical Center Groningen · University of Groningen
Affiliation as printed
Department of Child and Adolescent Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
-
Affiliation as printed
Triversum - GGZ-NHN, Child and Adolescent Psychiatry, Alkmaar, the Netherlands
-
Radboud University Medical Center · Donders Institute for Brain, Cognition and Behaviour
Affiliation as printed
Department of Human Genetics, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands
Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands
-
Affiliation as printed
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
Radboud University Medical Center · Donders Institute for Brain, Cognition and Behaviour
Affiliation as printed
Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
-
National Institute for Public Health and the Environment
Affiliation as printed
National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands
-
Radboud University Medical Center
Affiliation as printed
Department of Psychiatry, Radboud University Medical Center, Nijmegen, The Netherlands
Karakter, Child and Adolescent Psychiatry, Reinier Postlaan 12, 6525, GC, Nijmegen, the Netherlands
Cited by 11 stored of 12
11 results
No patents citing this paper on Lens.org (checked 2026-10-11).