Developmental Origins of Attention Deficit Hyperactivity Disorder

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Inattention; Impulsivity; Anxiety

Treatments: Behavioral: Whole Food, Nutrient-Dense Dietary Intervention; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01982422

6749

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups, including a placebo group

Dietary Intervention

Experimental group

Description:

A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.

Treatment:

Behavioral: Whole Food, Nutrient-Dense Dietary Intervention

Standard-of Care Group

Placebo Comparator group

Description:

This group will receive normal standard-of-care for pregnancy.

Treatment:

Behavioral: Standard of Care