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IRCT20130223012571N6 IRCT 2018-01-08 Yazd University of Medical Sciences The effect of DASH diet on attention deficit and hyperactivity disorder (ADHD) in children The effect of the DASH diet on the severity of attention deficit and hyperactivity disorder (ADHD) symptoms in children 2016-11-21 anticipated 60 Complete https://irct.ir/trial/12623 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The first 60 participants will be randomized to DASH or control diet (30 participants in each group) using simple randomization method by SPSS software. When the 60th participant entered to the study, the participants will be included in the trial using block randomization with the block size of 10. The allocation concealment was done by putting the randomized groups in sealed opaque envelopes, therefore the investigator could not predict the intervention group of invited participants before opening the envelopes. N/A Attention deficit hyperactivity disorder. Intervention 1: Control group: The usual diet which is similar to the usual Iranian diet with a macro-nutrient composition of 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Intervention 2: Intervention group: The Dietary Approaches to Stop Hypertension (DASH) diet, which is characterized by high intake of fruits, vegetables, low-fat dairy products, whole grains, poultry, fish, nuts and legumes and low intake of saturated fat, red meat, sweets, food colors, and sweetened beverages. The macro-nutrient composition of the diet will be 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Yes - There is a plan to make this available What will be shared: Data on the baseline and after treatment values of primary and secondary outcome variables will be available for researchers. When: Data will be available after the summary data become published. To whom: The data will be available for all researchers interested in the subject. Conditions: Data will be available if the interested researcher(s) fills the proposal for a joint project and the sponsor of the study (Shahid Sadoughi University of Medical Sciences) confirms the protocol of the project. Where to obtain: The data can be obtained from: ​Dr. Amin Salehi-Abargouei, Ph.D. in Nutrition Department of Nutrition Faculty of Public Health Sahid Sadoughi University of Medical Sciences Yazd, PO Code 8915173160 Iran Tel:+98-35-31492229 Fax:+98-35-38209119 Email: abargouei@ssu.ac.ir Alternate email: abargouei@gmail.com How to obtain: The interested investigators should provide a brief description of the data needed and their reason for asking the data by contacting the principal investigator. The principal investigator will assess the possibility of sharing the data and if applicable will ask for a joint proposal. The joint proposal will be sent to the vice chancellery for research, ShahidSadoughi University of Medical Sciences (the sponsor) and the data will be sent by the principal investigator if the sponsor confirms the cooperation. Comments:
public Yadollah khoshbakht
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) ​8915173160 +98 35 3820 9100 Y.khoshbakht1369@gmail.com Nutrition and Food Security Research Center, Shahid Sadughi University of medical Sciences, Yazd, Ir scientific Amin Salehi-Abargouei
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
Yazd Iran (Islamic Republic of) ​8915173160 +98 35 3820 9100 abargouei@ssu.ac.ir Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, I Iran (Islamic Republic of) Children aged 7-12 years; Diagnosis of ADHD according to DSM-IV criteria 7 years 12 years Both A sudden change in the diet; Intending not to follow the diet by participants; Use of medication during the intervention period; Unwillingness to continue participating in the study for any reason F90 Attention-deficit hyperactivity disorders Lifestyle Lifestyle Control group: The usual diet which is similar to the usual Iranian diet with a macro-nutrient composition of 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Intervention group: The Dietary Approaches to Stop Hypertension (DASH) diet, which is characterized by high intake of fruits, vegetables, low-fat dairy products, whole grains, poultry, fish, nuts and legumes and low intake of saturated fat, red meat, sweets, food colors, and sweetened beverages. The macro-nutrient composition of the diet will be 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins. Inattention. Timepoint: Before the study. One , two and three months after the start of the study. Method of measurement: Swanson, Nolan and Pelham (SNAP) Questionnaire. Hyperactivity. Timepoint: Before the study. One , two and three months after the start of the study. Method of measurement: Swanson, Nolan and Pelham (SNAP) Questionnaire. Inattention with Hyperactivity. Timepoint: Before the study. One , two and three months after the start of the study. Method of measurement: Abbreviated ten item Conner’s scale(ACS), Strengths and Difficulties Questionnaire (SDQ) and Swanson, and Nolan and Pelham (SNAP) Questionnaire. Blood pressure. Timepoint: Before starting the study. One, two and three months after the start of the study. Method of measurement: Sphygmomanometer. Weight. Timepoint: Before starting the study. One, two and three months after the start of the study. Method of measurement: Scales. Height. Timepoint: Before starting the study. One, two and three months after the start of the study. Method of measurement: Meter. Yazd University of Medical Sciences Approved 2016-11-05 Ethics committee of Shahid Sadoughi University of Medical Sciences Yazd Yazd, Bahonar Square, Research Deputy Yazd Yazd Iran (Islamic Republic of)