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Developmental Origins of Attention Deficit Hyperactivity Disorder

Developmental Origins of Attention Deficit Hyperactivity Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01982422
Enrollment
24
Registered
2013-11-13
Start date
2012-08-31
Completion date
2014-08-31
Last updated
2019-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Impulsivity, Inattention

Keywords

Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease

Brief summary

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

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.

Interventions

BEHAVIORALWhole Food, Nutrient-Dense Dietary Intervention

The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.

BEHAVIORALStandard of Care

Normal standard-of-care for pregnancy.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Functional neuroconnectivity of neonate assessed by MRI2-5 weeks after birthMRI will be used to examine brain morphology and functional connectivity in the neonates.

Secondary

MeasureTime frameDescription
Blood nutrient concentrationsAssessed at consent and end of 3rd trimesterMaternal 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026