Attention Deficit Hyperactivity Disorder: Nutrition and Environment
Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder
1 other identifier
interventional
70
1 country
1
Brief Summary
In this study the investigators aim to investigate the relationship between environmental factors, lifestyle and symptoms of Attention Deficit Hyperactivity Disorder (ADHD). Initially the investigators intend to measure the relationship between nutritional quality, exercise and sleep and ADHD symptoms. And then measure whether a change made in the diet can improve the symptoms of ADHD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedDecember 21, 2016
December 1, 2016
6 months
December 1, 2016
December 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Conners
Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type.
At 3 and 6 months
Secondary Outcomes (7)
Change in sleep
At 3 and 6 months
Change in exercise markers
At 3 and 6 months
Change in Anthropometry I
At 3 and 6 months
Change in Anthropometry II
At 3 and 6 months
Change in Anthropometry III
At 3 and 6 months
- +2 more secondary outcomes
Study Arms (2)
Nutritional intervention
EXPERIMENTALPatients subject to nutritional education by CINUSA group protocol
No intervention
NO INTERVENTIONPatients not subject to nutritional education
Interventions
Nutritional education trough a personal online nutritional consultant
Eligibility Criteria
You may qualify if:
- Both genders
- Ages 8-16 years
- ADHD proved
You may not qualify if:
- Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac disease, pancreatitis, hepatitis, HIV...
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital EL Escorial
El Escorial, Madrid, 28200, Spain
Related Publications (1)
Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.
PMID: 37058600DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Andres Blumenfeld Olivares, MD
Hospital El Escoral
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatrician, Responsible of Pediatric Endocrinology. Principal Investigator.
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 21, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
December 21, 2016
Record last verified: 2016-12