Developmental Origins of Attention Deficit Hyperactivity Disorder

Not Applicable

Completed

• Conditions: Inattention; Anxiety; Impulsivity
• Interventions: Behavioral: Whole Food, Nutrient-Dense Dietary Intervention; Behavioral: Standard of Care

• Registration Number: NCT01982422
• Lead Sponsor: Oregon Health and Science University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Primary Completion: 2014-05
• Study Completion: 2014-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Intervention	Whole Food, Nutrient-Dense Dietary Intervention	A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.
Standard-of Care Group	Standard of Care	This group will receive normal standard-of-care for pregnancy.

Primary Outcome Measures

Name	Time	Method
Functional neuroconnectivity of neonate assessed by MRI	2-5 weeks after birth	MRI will be used to examine brain morphology and functional connectivity in the neonates.

Secondary Outcome Measures

Name	Time	Method
Blood nutrient concentrations	Assessed at consent and end of 3rd trimester	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.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States