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.
ADHD
Children
Cost-effectiveness
Dietary treatment
Short and long-term effects
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
27 05 2020
27 05 2020
Historique:
received:
17
02
2020
accepted:
30
03
2020
entrez:
29
5
2020
pubmed:
29
5
2020
medline:
15
12
2020
Statut:
epublish
Résumé
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. 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. 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. www.trialregister.nl, NTR5434. Registered at October 11th, 2015.
Sections du résumé
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.
Identifiants
pubmed: 32460725
doi: 10.1186/s12888-020-02576-2
pii: 10.1186/s12888-020-02576-2
pmc: PMC7251686
doi:
Banques de données
NTR
['NTR5434']
Types de publication
Clinical Trial Protocol
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
262Subventions
Organisme : H2020 Research and innovation programme
ID : 728018
Pays : International
Références
Lancet. 2011 May 7;377(9777):1567-8; author reply 1568
pubmed: 21550472
Lancet. 2011 Feb 5;377(9764):494-503
pubmed: 21296237
PLoS One. 2017 Jan 25;12(1):e0169277
pubmed: 28121994
CNS Drugs. 2011 Jul;25(7):539-54
pubmed: 21699268
J Ment Health Policy Econ. 2014 Sep;17(3):119-29
pubmed: 25543115
Soc Psychiatry Psychiatr Epidemiol. 2004 Aug;39(8):613-7
pubmed: 15300371
J Child Psychol Psychiatry. 2018 Mar;59(3):232-246
pubmed: 28967099
Lancet. 2011 May 7;377(9777):1567; author reply 1568
pubmed: 21550473
Pediatrics. 2017 Feb;139(2):
pubmed: 28138007
Lancet Psychiatry. 2015 Mar;2(3):271-4
pubmed: 26359904
J Child Psychol Psychiatry. 2014 May;55(5):416-27
pubmed: 24552603
Qual Life Res. 2006 Aug;15(6):1005-21
pubmed: 16900281
Cochrane Database Syst Rev. 2018 May 09;5:CD012069
pubmed: 29744873
J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):86-97.e8
pubmed: 22176942
Psychol Assess. 2018 Sep;30(9):1174-1185
pubmed: 29927304
JAMA. 1995 Nov 22-29;274(20):1617-21
pubmed: 7474248
Int J Educ Psychol Assess. 2012 Apr;10(1):51-70
pubmed: 26504617
Pediatrics. 2011 Nov;128(5):1007-22
pubmed: 22003063
J Atten Disord. 2012 Aug;16(6):510-6
pubmed: 21807955
J Child Adolesc Psychopharmacol. 2020 Apr;30(3):166-172
pubmed: 32101469
Healthc Inform Res. 2011 Mar;17(1):29-37
pubmed: 21818455
Lancet Psychiatry. 2018 Sep;5(9):727-738
pubmed: 30097390
J Child Psychol Psychiatry. 1997 Jul;38(5):581-6
pubmed: 9255702
Lancet. 2011 Feb 5;377(9764):446-8
pubmed: 21296224
J Child Psychol Psychiatry. 2016 Nov;57(11):1218-1226
pubmed: 26990084
Nat Rev Dis Primers. 2015 Aug 06;1:15020
pubmed: 27189265
J Clin Child Adolesc Psychol. 2013;42(6):749-61
pubmed: 23477379
J Child Psychol Psychiatry. 2017 Jun;58(6):663-678
pubmed: 28295312
Med Care. 1986 Jan;24(1):67-74
pubmed: 3945130
Pediatrics. 2015 Apr;135(4):e994-1001
pubmed: 25733754
J Affect Disord. 2019 Jun 1;252:160-173
pubmed: 30986731
J Atten Disord. 2019 Feb;23(3):293-304
pubmed: 27401241
Am J Psychiatry. 2013 Mar;170(3):275-89
pubmed: 23360949
J Affect Disord. 2019 Jan 15;243:290-296
pubmed: 30257225