An interventional study of Whole Food, Nutrient-Dense Dietary Intervention and Standard of Care in Inattention, Impulsivity and Anxiety, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Prevention
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.
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 24 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This group will receive normal standard-of-care for pregnancy.
Behavioral: Standard of Care
The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.
Normal standard-of-care for pregnancy.
Functional neuroconnectivity of neonate assessed by MRI
MRI will be used to examine brain morphology and functional connectivity in the neonates.
Time frame: 2-5 weeks after birth
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.
Time frame: Assessed at consent and end of 3rd trimester
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oregon Health and Science University