The Impact of the MIND Diet on ADHD Symptom Severity in Children With ADHD Not on Pharmacotherapy: A Randomized Controlled Trial in Lebanon
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 158
- Primary Endpoint
- ADHD Symptom Severity
Study Overview
Brief Summary
This study, titled "The Effect of the MIND Diet on ADHD Symptom Severity in Children with ADHD Not on Pharmacotherapy: A Randomized Controlled Trial in Lebanon," aims to evaluate whether a structured dietary intervention can improve behavioral and cognitive outcomes in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD is one of the most common neurodevelopmental disorders in childhood and is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with academic performance, social functioning, and daily activities. Although pharmacological treatments such as stimulant medications are considered the standard approach for ADHD management, many families either prefer to delay medication use or avoid it altogether due to concerns about side effects, stigma, or personal preferences. Consequently, there is growing interest in complementary and non-pharmacological approaches that may help manage symptoms and improve quality of life for children with ADHD.
The present study investigates the potential benefits of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay), a dietary pattern that combines elements of the Mediterranean diet and the DASH diet. The MIND diet emphasizes foods associated with brain health and anti-inflammatory properties, including green leafy vegetables, berries, nuts, whole grains, olive oil, fish, legumes, and poultry, while limiting foods that may negatively affect cognitive function such as processed foods, fried foods, red meats, and sweets. Although the MIND diet has demonstrated neuroprotective effects in adults, particularly in relation to cognitive decline and neurodegenerative diseases, its potential role in managing ADHD symptoms in children remains largely unexplored. This study therefore seeks to address an important gap in the literature by evaluating whether dietary patterns that support brain health can influence behavioral and cognitive outcomes in pediatric ADHD.
The research employs a two-arm randomized controlled trial (RCT) design and will recruit a total of 158 children aged 6-12 years who have been diagnosed with ADHD and are not currently receiving pharmacological treatment. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, which will follow the MIND diet, or a control group, which will receive general dietary advice based on standard nutritional recommendations. The intervention will last for 12 weeks, with data collected at baseline and at monthly follow-up visits throughout the study. During the intervention, families in the MIND diet group will receive education sessions from a nutritionist, educational materials including recipes and meal plans, and biweekly phone calls to support adherence and address any difficulties in implementing the diet.
The primary outcome of the study is the change in ADHD symptom severity, measured using the ADHD Rating Scale-IV (ADHD-RS-IV), a validated instrument completed by both parents and teachers. Assessing symptoms from both home and school settings provides a comprehensive evaluation of behavioral changes over time. Secondary outcomes include measures of executive functioning, assessed using the Behavior Rating Inventory of Executive Function (BRIEF) and selected tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB). These tools allow the study to evaluate both subjective and objective aspects of cognitive functioning, including working memory, planning, and inhibitory control.
Additional outcomes include assessments of quality of life, physical health, and dietary adherence. Quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL), while broader emotional and behavioral functioning will be evaluated using the Strengths and Difficulties Questionnaire (SDQ). Anthropometric measurements such as height, weight, and body mass index (BMI) will be recorded throughout the study to assess potential physical health changes associated with the dietary intervention. Dietary adherence will be monitored using repeated dietary records and a sociodemographic and barriers questionnaire designed to identify factors influencing families' ability to follow the diet. These analyses will also explore predictors of adherence, including caregiver involvement, socioeconomic status, and the child's age.
The study is particularly relevant within the Lebanese and broader Middle East and North Africa (MENA) context, where stigma surrounding mental health and concerns about medication often contribute to underutilization of mental health services. By examining a culturally acceptable and accessible intervention based on widely available foods, the study aims to provide families with an alternative or complementary strategy for ADHD management.
Overall, this research seeks to determine whether adherence to the MIND diet can reduce ADHD symptom severity, improve executive function
Detailed Description
Background and Rationale Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders affecting children worldwide. It is characterized by persistent patterns of inattention, hyperactivity, and impulsivity that interfere with development and functioning across multiple settings, including home, school, and social environments. Children with ADHD frequently experience difficulties in academic performance, behavioral regulation, executive functioning, and interpersonal relationships. In addition to these immediate challenges, untreated ADHD may lead to long-term consequences including poor educational attainment, social difficulties, substance use, and psychiatric comorbidities in adolescence and adulthood.
Standard treatment for ADHD typically involves pharmacological therapy, most commonly stimulant medications, combined with behavioral and psychosocial interventions. Pharmacotherapy has been consistently shown to reduce core ADHD symptoms and improve functioning in many patients. Despite its effectiveness, medication treatment is not always acceptable or accessible for all families. Some parents express concerns about potential side effects, long-term medication use, or the stigma associated with psychiatric treatment. In certain cultural contexts, including the Middle East and North Africa region, stigma related to mental health conditions and psychiatric medication can further contribute to delays in treatment initiation.
As a result, there has been increasing interest in non-pharmacological approaches that may complement or serve as alternatives to traditional ADHD treatments. Lifestyle factors such as diet, sleep, and physical activity have emerged as potential contributors to cognitive and behavioral functioning in children. In particular, nutrition has gained attention as a potentially modifiable factor influencing neurodevelopment and mental health outcomes.
Dietary patterns can influence brain health through several biological pathways, including inflammation, oxidative stress, and neurotransmitter synthesis. Diets rich in whole foods, antioxidants, and unsaturated fats have been associated with improved cognitive functioning and mental well-being. Conversely, diets high in processed foods, saturated fats, and refined sugars have been linked to poorer cognitive outcomes and increased behavioral problems in children.
The MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) is a dietary pattern specifically designed to promote brain health and reduce cognitive decline. It combines elements from two well-established dietary patterns: the Mediterranean diet and the Dietary Approaches to Stop Hypertension (DASH) diet. The MIND diet emphasizes the consumption of foods associated with neuroprotection and anti-inflammatory effects, including green leafy vegetables, berries, nuts, whole grains, olive oil, legumes, fish, and poultry. At the same time, it encourages limiting foods that may negatively affect cognitive health, such as fried foods, red meats, processed foods, butter, and sweets.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged 6 to 12 years at the time of enrollment
- •Clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD) based on DSM-5 diagnostic criteria
- •Not currently receiving pharmacological treatment for ADHD
- •Child and caregiver willing to participate in the study procedures for the full 12-week intervention period
Exclusion Criteria
- •Current use of stimulant or non-stimulant pharmacological treatment for ADHD
- •Presence of medical conditions requiring specialized dietary restrictions (e.g., severe food allergies, metabolic disorders, or medically prescribed diets)
- •Severe neurological or developmental disorders that may interfere with participation or study assessments
- •Serious chronic medical illnesses that may affect growth, nutrition, or participation in dietary interventions
- •Inability of caregiver to comply with study procedures or dietary monitoring requirements
Outcomes
Primary Outcomes
ADHD Symptom Severity
Time Frame: ADHD symptom severity will be assessed at week 4, week8 snd at the end of the study (week 12)
ADHD- Rating Scale
Secondary Outcomes
- Executive Function(Will be assessed AT baseline, week 4, week 8, and week 12)
Investigators
Fadi Maalouf
Professor Doctor
American University of Beirut Medical Center