The Feasibility of a Dietary Intervention in Children With ADHD

NCT03737877 | Unknown

• 1 other identifier: SMEC_2017-18_132
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.

Conditions

ADHD; Diet Modification

Keywords

ADHD; Diet Modification

Outcome Measures

Primary Outcomes (1)

• Completion of study

  What proportion of participants completed the study?

  final week

Secondary Outcomes (13)

• Adherence to diet

  week 6 of diet

• Side-effects

  duration of the 6 week diet

• The Conners Clinical Index (Conners CI) - Parent-report

  Baseline and week 6 of diet

• The Conners Clinical Index (Conners CI) - Teacher-report

  Baseline and week 6 of diet

• The Conners Clinical Index (Conners CI) - Self-report

  Baseline and week 6 of diet

Study Arms (1)

Diet modification

EXPERIMENTAL

Other: Diet modification

Interventions

Diet modification OTHER

The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles: * Eat at least seven portions of different varieties of fruit and vegetables each day. * Have a 12 hour overnight break from food (water only during this time). * Drink a Kefir drink each day - provided free of charge. * Eat a microbiome friendly, protein rich, breakfast from our menu. * Reduce sugar and artificial sweeteners.

Diet modification

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent-reported diagnosis of ADHD.
• Children aged between 8 years - 13 years 11 months at onset of study.
• Children not taking ADHD medication (such as methylphenidate) at the time of the study.
• Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments.
• Both males and females are eligible to take part.
• Children with a co-occurring diagnosis will be accepted onto the trial.
• Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.

You may not qualify if:

• Children undergoing a current course of behavioural therapy.
• Children currently on ADHD medication (such as methylphenidate).
• Children who have taken antibiotics in the past 3 months

Sponsors & Collaborators

• St Mary's University College: lead
• Goldsmiths, University of London: collaborator

Study Sites (1)

St Mary's University

London, TW14SX, United Kingdom

Location

Related Publications (1)

• Lawrence K, Myrissa K, Toribio-Mateas M, Minini L, Gregory AM. Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study. Pilot Feasibility Stud. 2022 May 23;8(1):108. doi: 10.1186/s40814-022-01058-4.

  PMID: 35606889 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: May 14, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: June 6, 2019

Record last verified: 2019-06

Locations

GB (1)