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Not Yet Recruiting NCT05619445

Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health

Conditions: Depression, Anxiety, Stress

Sex: Female
Ages: 19 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 30
Sponsor: University of Idaho

Location: United States

Summary

The goals of this study are to assess the feasibility and acceptability of a dietary intervention to increase choline intake through whole foods (eggs) in pregnant and lactating women for mental health benefits. We will achieve these goals through the following specific aims:To determine the effects of including eggs as a source of choline in the diets of pregnant and lactating women on biomarkers, we will measure concentrations of choline and choline metabolites in maternal serum and breastmilk at 24-26 weeks gestation and 4-6 weeks postpartum.To evaluate adherence to a food-based dietary choline intervention in pregnant and lactating women, we will track intake via daily photo and written food logs.To assess the feasibility of collecting repeated measures of dietary intake and maternal depression, anxiety, and stress in the perinatal period, we will track completion rates for project surveys.The data from this study will inform the design and sample size calculations for a longitudinal cohort study that will assess neurological outcomes for both mother and child and follow the offspring over time to reassess mental health and cognitive development in preschool-aged children.Choline is an underconsumed nutrient of concern for public health, specifically during pregnancy and lactation. There is limited data on biomarker or health outcomes related to perinatal choline intake. Determining relationships between perinatal choline intake and maternal mental health has the potential to impact public health by ultimately informing development of nutrition education materials in the clinical setting focused on encouraging maternal perinatal choline intake through whole foods such as eggs.

Eligibility Criteria

Inclusion Criteria:18 to 26 weeks pregnanthave access to internet and an electronic device (phone, tablet, or computer)willing to consume eggsExclusion Criteria:score 11 or higher on the Edinburgh Postnatal Depression Scaleunder 19 years of agenon-English speakingpregnant with multiplesconsume a vegan dietself-reported use of alcohol or drugs during pregnancyhave diagnosed egg allergyhave physical, cognitive, or logistical limitations to being able to follow the study protocoldo not plan to breastfeed

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05619445). StuddyBuddy aggregates publicly available trial information.