Developmental Origins of Attention Deficit Hyperactivity Disorder

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Impulsivity; Inattention
• Intervention / Treatment: Behavioral: Whole Food, Nutrient-Dense Dietary Intervention; Behavioral: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary Intervention; 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; The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.
Placebo Comparator: Standard-of Care Group; This group will receive normal standard-of-care for pregnancy.	Behavioral: Standard of Care; Normal standard-of-care for pregnancy.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Joel Nigg, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Nutrition; Diet; Attention Deficit and Hyperactivity Disorder; Developmental Origins of Disease
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Impulsive Behavior
• Other Study ID Numbers: 6749