Developmental Origins of Attention Deficit Hyperactivity Disorder

Study Overview
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Brief Summary
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This is a study evaluating the relationship between prenatal nutrition and neural development in infants born to mothers with Attention Deficit Hyperactivity Disorder (ADHD). We are hypothesizing that women randomized to a whole food, nutrient-dense diet during their 3rd trimester of pregnancy will have infants with more advanced neural development as compared to infants born to mothers receiving standard-of-care treatment.

Detailed Description
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Pregnant women with ADHD will be recruited from the patient population at Oregon Health & Science University (OHSU). They will be recruited during their 1st or 2nd trimester. After consent, baseline measures will be collected including height, weight, body composition measurements using calipers, 24-hour dietary recalls, and blood and urine samples. Women will also complete questionnaires regarding ADHD symptoms, stress, depression, and lifestyle. Women will be given a one-week food diary to fill out at home, which will be mailed in upon completion. Upon receipt of the food diary, women will be randomized into either a nutrition intervention group or a standard-of-care group. Women who are randomized to the intervention group will receive individual nutritional counseling every 2 weeks during their 3rd trimester of pregnancy. Before delivery, the baseline measures described above will again be collected. At delivery, placenta and cord blood samples will be taken. After birth, the infant will undergo an MRI between 2 and 5 weeks of age. The scan is completed while the baby sleeps, and special ear protection is worn to limit sleep disruption from the noise of the MRI. When the infant is 3 months old, mothers will complete questionnaires about infant feeding, sleep and behavior.

Official Title
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Developmental Origins of Attention Deficit Hyperactivity Disorder

Conditions
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Inattention, Impulsivity, Anxiety

Intervention / Treatment
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* Behavioral: Whole Food, Nutrient-Dense Dietary Intervention
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women in general good health 18 years of age or older Confirmed pregnancy and currently between 8 and 24 weeks pregnant With symptoms of inattention or impulsivity Exclusion Criteria: Obstetrician confirmed high-risk pregnancy Current drug/alcohol addiction Current smoker Unwilling/unable to discontinue psychiatric medication during pregnancy Comorbid schizophrenia, bipolar, or major depressive disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Intervention<br>A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake. | Behavioral: Whole Food, Nutrient-Dense Dietary Intervention<br>* The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.<br>|
| Placebo Comparator: Standard-of Care Group<br>This group will receive normal standard-of-care for pregnancy. | Behavioral: Standard of Care<br>* Normal standard-of-care for pregnancy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional neuroconnectivity of neonate assessed by MRI | MRI will be used to examine brain morphology and functional connectivity in the neonates. | 2-5 weeks after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood nutrient concentrations | Maternal blood nutrient concentrations will be examined to assess whether or not the intervention group had higher nutrient levels in the 3rd trimester than the standard-of-care group. | Assessed at consent and end of 3rd trimester | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease