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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
May 27, 2020
Annick Bosch et al. (22 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the short-term (5 weeks) and long-term (1 year) effects of an elimination diet and a healthy diet versus care as usual (CAU) in children with ADHD.

Results Summary

The study is ongoing, so no results are reported yet, but it aims to assess treatment response, nutritional quality, cost-effectiveness, and long-term effects of dietary interventions for ADHD.

Population

Children aged 5-12 years with ADHD.

Effective Dosage

Not specified

Duration

5 weeks (short-term), 1 year (long-term)

Interactions

None mentioned

Extracted Claims (3)
InterventionDirectionEndpointPopulationDosageImpactClaim #
elimination diet (ED)
decrease
Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms
children with ADHD
-
might be an effective treatment
#1
elimination diet
decrease
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)
children with ADHD
≥ 30% reduction
effects
#2
healthy diet
decrease
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)
children with ADHD
≥ 30% reduction
effects
#3
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.

Medical Subject Headings (MeSH)
ChildFemaleHumansMaleAttention Deficit Disorder with HyperactivityDiet, HealthyNetherlandsParentsResearch DesignSchool TeachersTreatment OutcomeRandomized Controlled Trials as TopicMulticenter Studies as Topic
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations6
Citations/Year1.2
Relative Citation Ratio0.52
NIH Percentile27.9%
Research Impact Scores
APT Score0.25
Weight Score2.31
Normalized Score0.67
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