ADHD Clinical Trial
Official title:
Nutritional and Environmental Conditions in Attention Deficit Hyperactivity Disorder
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | June 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Both genders - Ages 8-16 years - ADHD proved Exclusion Criteria: - Presence of serious or chronic illnesses: leukemia, spinal cord injury, celiac disease, pancreatitis, hepatitis, HIV... |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Spain | Hospital EL Escorial | San Lorenzo de El Escorial | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital El Escorial |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Conners | Conners conduct questionnaire: attention deficit and disruptive behavior disorders; hyperactivity; and combined type. | At 3 and 6 months | Yes |
Secondary | Change in sleep | Markers related to sleep: adapted Short Form Health Survey-36 for sleep quality. | At 3 and 6 months | Yes |
Secondary | Change in exercise markers | Markers related to activity: Ipad-Minnesota questionnaire for physical activity. | At 3 and 6 months | Yes |
Secondary | Change in Anthropometry I | Arm circumference and triceps skinfold, muscle area and arm fat area using the manual for evaluation of body composition in humans of the Spanish population. | At 3 and 6 months | Yes |
Secondary | Change in Anthropometry II | BMI, calculated using height and weight. | At 3 and 6 months | Yes |
Secondary | Change in Anthropometry III | % total body fat,% visceral fat,% muscle. Measured by electrical bioimpedance, apparatus for medical use which analyzes the opposition of a biological tissue (fat) to the passage of an electric current through it. It is a noninvasive, painless study based on the application of an electrical current through the body and the record of physical parameters that depend on body's water content. The investigators will use a M230 InBody bioimpedance, multi-frequency (20 to 100 Hz), tetra-pole or similar. | At 3 and 6 months | Yes |
Secondary | Change in Anthropometry IV | Arm circumference and triceps skinfold, muscle area and arm fat area using the manual for evaluation of body composition in humans of the Spanish population. | At 3 and 6 months | Yes |
Secondary | Change in nutritional habits | Kidmed ( mediterranean diet adherence) questionnaire at baseline, 3 and 6 month | At 3 and 6 months |
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