Developmental Origins of Attention Deficit Hyperactivity Disorder
Primary Purpose
Inattention, Impulsivity, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Food, Nutrient-Dense Dietary Intervention
Standard of Care
Sponsored by
About this trial
This is an interventional prevention trial for Inattention focused on measuring Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dietary Intervention
Standard-of Care Group
Arm Description
A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.
This group will receive normal standard-of-care for pregnancy.
Outcomes
Primary Outcome Measures
Functional neuroconnectivity of neonate assessed by MRI
MRI will be used to examine brain morphology and functional connectivity in the neonates.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01982422
First Posted
November 6, 2013
Last Updated
August 8, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01982422
Brief Title
Developmental Origins of Attention Deficit Hyperactivity Disorder
Official Title
Developmental Origins of Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inattention, Impulsivity, Anxiety
Keywords
Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary Intervention
Arm Type
Experimental
Arm Description
A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake.
Arm Title
Standard-of Care Group
Arm Type
Placebo Comparator
Arm Description
This group will receive normal standard-of-care for pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Whole Food, Nutrient-Dense Dietary Intervention
Intervention Description
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
Intervention Name(s)
Standard of Care
Intervention Description
Normal standard-of-care for pregnancy.
Primary Outcome Measure Information:
Title
Functional neuroconnectivity of neonate assessed by MRI
Description
MRI will be used to examine brain morphology and functional connectivity in the neonates.
Time Frame
2-5 weeks after birth
Secondary Outcome Measure Information:
Title
Blood nutrient concentrations
Description
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.
Time Frame
Assessed at consent and end of 3rd trimester
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Nigg, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Developmental Origins of Attention Deficit Hyperactivity Disorder
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