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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Intervention | Experimental | A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake. |
|
| Standard-of Care Group | Placebo Comparator | This group will receive normal standard-of-care for pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Food, Nutrient-Dense Dietary Intervention | Behavioral | The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Nigg, PhD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97223 | United States |
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| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D001008 | Anxiety Disorders |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000098845 | Developmental Origins of Health and Disease |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Behavioral | Normal standard-of-care for pregnancy. |
|
| D011297 | Prenatal Exposure Delayed Effects |
| D049188 | Prenatal Injuries |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |