InattentionNCT01982422
Developmental Origins of Attention Deficit Hyperactivity Disorder
A study testing Whole Food, Nutrient-Dense Dietary Intervention in people with Inattention and Impulsivity, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inattention, Impulsivity, Anxiety
- What is being tested?
- Whole Food, Nutrient-Dense Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97223
About this study
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.
Read the 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
- Being tested
- Whole Food, Nutrient-Dense Dietary Intervention, Standard of Care
- Keywords
- Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease
- Medical subject headings
- Impulsive Behavior, Anxiety Disorders, Attention Deficit Disorder with Hyperactivity, Developmental Origins of Health and Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food, Nutrient-Dense Dietary InterventionBehavioural
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 CareBehavioural
Normal standard-of-care for pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | A whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake. Receives: Behavioral: Whole Food, Nutrient-Dense Dietary Intervention |
| Standard-of Care Group | Placebo comparator | This group will receive normal standard-of-care for pregnancy. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional neuroconnectivity of neonate assessed by MRI
MRI will be used to examine brain morphology and functional connectivity in the neonates.
Measured: 2-5 weeks after birth
Secondary outcomes (1)
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.
Measured: Assessed at consent and end of 3rd trimester
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InattentionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Nigg, Ph.D., Oregon Health and Science University
- Investigators
- Joel Nigg, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982422
- Sponsor's protocol ID
- 6749
- Status last verified
- Aug 2019
- First submitted
- 6 Nov 2013
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Origins of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01982422
- Acronym / sponsor ID
- 6749
- Conditions
- Inattention, Impulsivity, Anxiety
- Keywords
- Attention Deficit and Hyperactivity Disorder, Nutrition, Diet, Developmental Origins of Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Behavioral: Whole Food, Nutrient-Dense Dietary InterventionA whole food, nutrient-dense dietary intervention which restricts processed foods high in food additives and optimizes micronutrient intake. |
| Standard-of Care Group | Placebo comparator | Behavioral: Standard of CareThis group will receive normal standard-of-care for pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food, Nutrient-Dense Dietary InterventionThe dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake. | Behavioural | Dietary Intervention |
| Standard of CareNormal standard-of-care for pregnancy. | Behavioural | Standard-of Care Group |
Primary outcome
Functional neuroconnectivity of neonate assessed by MRI
Time frame: 2-5 weeks after birth
MRI will be used to examine brain morphology and functional connectivity in the neonates.
1 secondary outcome
Blood nutrient concentrations
Time frame: Assessed at consent and end of 3rd trimester
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Nigg, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food, Nutrient-Dense Dietary Intervention in people with Inattention and Impulsivity, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional neuroconnectivity of neonate assessed by MRI (time frame: 2-5 weeks after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.