Developmental Origins of Attention Deficit Hyperactivity Disorder

NCT ID: NCT01982422

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Inattention; Impulsivity; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dietary Intervention

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

Group Type: EXPERIMENTAL

Whole Food, Nutrient-Dense Dietary Intervention

Intervention Type: BEHAVIORAL

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

Standard-of Care Group

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

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

Normal standard-of-care for pregnancy.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care

Normal standard-of-care for pregnancy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Joel Nigg, Ph.D.

Director, Division of Psychology and Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Nigg, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

6749

Identifier Type: -

Identifier Source: org_study_id