ADHD, Diet Modification
Conditions
Keywords
ADHD, Diet Modification
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.
Detailed description
Children with Attention Deficit Hyperactivity Disorder (ADHD) can suffer debilitating symptoms, including problematic behaviour and sleep. Research suggests dietary manipulations may be a helpful treatment option for children with ADHD, although the most effective are highly restrictive, with little known about why they might work. Optimising gut bacteria in individuals with ADHD may help alleviate some of the symptoms of this condition via the gut-brain-axis and would provide a plausible mechanism by which dietary interventions operate. We propose to conduct a feasibility pilot study of a dietary intervention designed to optimise gut bacteria in children diagnosed with ADHD.
Interventions
OTHERDiet modification
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.
Sponsors
Goldsmiths, University of London
St Mary's University College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Parent-reported diagnosis of ADHD. 2. Children aged between 8 years - 13 years 11 months at onset of study. 3. Children not taking ADHD medication (such as methylphenidate) at the time of the study. 4. Parental permission to attend three group sessions and for themselves and their child to complete the requisite assessments. 5. Both males and females are eligible to take part. 6. Children with a co-occurring diagnosis will be accepted onto the trial. 7. Children with food allergies/sensitivities/coeliac disease will be accepted onto the trial.
Exclusion criteria
1. Children undergoing a current course of behavioural therapy. 2. Children currently on ADHD medication (such as methylphenidate). 3. Children who have taken antibiotics in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of study | final week | What proportion of participants completed the study? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side-effects | duration of the 6 week diet | Parent-reported side effects during course of study. (Qualitative) (More/more side-effects reflect poorer outcome). |
| The Conners Clinical Index (Conners CI) - Parent-report | Baseline and week 6 of diet | Parental report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator |
| The Conners Clinical Index (Conners CI) - Teacher-report | Baseline and week 6 of diet | Teacher report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator |
| The Conners Clinical Index (Conners CI) - Self-report | Baseline and week 6 of diet | Child self-report of clinical symptoms (percentile score - higher score reflects more/more severe symptoms) 1. Disruptive Behavior Indicator 2. Learning and Language Disorder Indicator 3. Mood Disorder Indicator 4. Anxiety Disorder Indicator 5. ADHD Indicator |
| Delayed Match to Sample test (Cambridge Neuropsychological Test Automated Battery - CANTAB) Latency (response time) Accuracy (correct patterns selected). | Baseline and week 6 of diet | Computerised test of visual working memory * DMS Percent Correct (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-100% - higher score reflects greater accuracy. * DMS Mean & Median Correct Latency (overall, for all delays, simultaneous, 0 sec delay, 4 sec delay, 12 sec delay). Range 0-∞ ms - higher score reflects worse performance. * DMS Correct Latency Standard Deviation. Range 0-∞ ms - higher score reflects worse performance. * DMS Mean Choices to Correct response. Range 0-4 - higher score reflects worse performance. * DMS Probability of Error Given Error. Range 0-1 - higher score reflects worse performance. |
| The Consensus Sleep Diary | Baseline and week 6 of diet | Record of sleep - used qualitatively to detect and remove artefacts from the data. |
| Adherence to diet | week 6 of diet | Percentage adherence to diet over the 4-week period based on parental report (range 0-100 % - high score reflecting greater degree of adherence). |
| Sleep self-report questionnaire | Baseline and week 6 of diet | Week long retrospective sleep survey (Scores range from 13-39 with a higher score indicating more/more severe sleep difficulties). |
| Actigraphy recordings | Baseline and week 6 of diet | Objective measure of sleep quality and daytime activity * Mean activity during sleep. Range 0-∞. A higher score = less sound sleep (worse). * Minutes spent awake during the down period. Range 0-∞. A higher score = less sound sleep (worse). * Sleep latency (time taken to fall asleep). Range 0-∞. A higher score = more time taken to fall asleep (worse). * Sleep efficiency (% down period spent asleep, after removing sleep latency). A higher score = better. * Wake after sleep onset (minutes spent awake during the down period after removing sleep latency). Range 0-∞. A higher score = less sound sleep (worse). * Sleep fragmentation (number of awakenings/ total minutes of sleep x 100) - Higher score = more fragmented sleep (worse). * Mean daytime activity (0-∞) not necessarily worse or better. |
| The Gastrointestinal Symptom Rating | Baseline and week 6 of diet | Questionnaire to evaluate common gastrointestinal symptoms Total scores range from 15-105 (with higher scores reflecting more/more severe gastrointestinal symptoms). Subscales: 1. Abdominal pain (abdominal pain, hunger pains and nausea). Range 3-21 - a high score reflects worse symptoms. 2. Reflux syndrome (heartburn and acid regurgitation). Range 3-21 - a high score reflects worse symptoms. 3. Diarrhoea syndrome (diarrhoea, loose stools and urgent need for defecation). Range 3-21 - a high score reflects worse symptoms. 4. Indigestion syndrome (borborygmus, abdominal distension, eructation and increased flatus). Range 3-21 - a high score reflects worse symptoms. Range 3-21 - a high score reflects worse symptoms. 5. Constipation syndrome (constipation, hard stools and feeling of incomplete evacuation). Range 3-21 - a high score reflects worse symptoms. |
| Stool sample analysis for commensal bacteria and microbial diversity using 16S rRNA sequencing | Baseline and week 6 of diet | Analysis of bacterial strains and diversity within stool sample |
| Treatment Acceptability Scale | Baseline and week 6 of diet | Questionnaire to assess the acceptability of the diet to parents of the children taking part in the study Score range 6-42 (High score reflects more positive attitude to treatment) |
| Children's Sleep Habits Questionnaire | Baseline and week 6 of diet | Parental report of child's sleep A Total Sleep Disturbances score is calculated as the sum of all CSHQ scored questions, and can range from 33 to 99. A higher score indicates more problematic sleep. |
Countries
United Kingdom
Outcome results
None listed