The effect of the DASH diet on the severity of attention deficit and hyperactivity disorder (ADHD) symptoms in children

The purpose of the study is to assess the effect of the dietary approaches to stop hypertension (DASH) diet on the severity of the ADHD compared to the usual diet.

This study will be a randomized controlled clinical trial on 60 children with attention deficit hyperactivity disorder (ADHD) referred to Shahid Sadoughi University of Medical Sciences' clinics, Yazd, Iran. The study participants will be followed for 3 months. After the diagnosis of ADHD, children will be entered into the study according to the eligibility criteria. Verbal and written information about the study protocol will be provided for the parents, and then they will sign an informed consent. Eligible individuals will be randomly assigned to the DASH diet or the control diet group.

Both diets will be designed based on the calculated energy requirements of the participants. Participants are asked to visit the center for each month, in order to determine the severity of ADHD based on Abbreviated ten item Conner’s Scale (ACS), Swanson, Nolan and Pelham Questionnaire (SNAP) and Strengths and Difficulties Questionnaire (SDQ) questionnaires, and assess the anthropometric indices, physical activity and dietary compliance rates. This process will be carried out for three times up to the end of the third month of follow-up.

Inclusion criteria: 1)Children aged 7-12 years; 2) Diagnosed with ADHD according to DSM-IV criteria Exclusion criteria: 1)A sudden change in the diet; 2) Intending not to follow the diet by participants; 3) Use of medication during the intervention period; 4) Unwillingness to continue participating in the study for any reason.

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. 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.

Participants will be visited each month, in order to determine the severity of ADHD based on Abbreviated ten item Conner’s Scale (ACS), Swanson, Nolan and Pelham Questionnaire (SNAP) and Strengths and Difficulties Questionnaire (SDQ), and to assess the anthropometric indices, physical activity, and dietary compliance rates. This process will be carried out each month up to the end of the third month of follow-up. The assessment of ADHD severity will be done by using three questionnaires including Abbreviated ten item Conner’s scale(ACS), Swanson, Nolan and Pelham Questionnaire (SNAP) and Strengths and Difficulties Questionnaire (SDQ). Anthropometric measurements will be done three times during each visit and their mean will be recorded as the final value. The physical activity will be assessed using three-day physical activity record which will be filled by parents before each visit. Furthermore, the parents will provide three-day dietary records each month to assess the compliance of the children with the intervention diets.

Nutrition and Food security research center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran

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.

Data on the baseline and after treatment values of primary and secondary outcome variables will be available for researchers.

Data will be available after the summary data become published.

The data will be available for all researchers interested in the subject.

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.

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

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.