Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorArkansas Children's Hospital Research Institute
About this trial
The investigators want to learn how women's diets may impact breastfeeding outcomes. This study will help the investigators learn more about how diet and social factors like food access may impact mothers' health, breastfeeding, and their baby's health. Participants will attend a visit before birth, then 11 visits as their baby grows up. All visits will be remote using RedCap, phone or video call, text messaging or any other communication modalities of preference to the participant. The investigators will ask for personal information about participants' family, home, and finances, health literacy, medical history, current medications, pregnancy complications, mental health (depression, quality of life), confidence in breastfeeding, eating habits, and plan to feed their baby. After childbirth, the investigators will ask about participants' delivery and child's health, and request access to their child's medical records. Across all visits, the investigators will ask participants to measure their weight, height, blood pressure, activity and sleep, and child's length; the investigators will also ask them to ship urine, stool, and breast milk samples. The investigators will obtain a 24-hour feeding log for the child, as well as a log of what the mother ate and drank over 24 hours.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
At least 30 weeks pregnant
Ability to engage in study procedures throughout the first 12 months postpartum
Disqualifiers
None
Trial population
This longitudinal prospective study will recruit a cohort representative of the state of Arkansas We will achieve this goal by designing a study with assessments that are fully developed for remote data and sample collections.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Maternal dietary intake
24 hour dietary recall using ASA24
Time frame
Third trimester of pregnancy and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 months postpartum2
Child dietary pattern
24 hour recall using NDSR
Time frame
0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month of age3
Breastfeeding outcomes
Exclusivity, duration and mixed feeding
Time frame
0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartumSecondary outcomes
1
Maternal weight
Smart scale
Time frame
Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum2
Human milk composition
macronutrients, micronutrients and non-nutritive components
Time frame
0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum or as long as lactating3
Blood pressure
Smart device, at home collection
Time frame
Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum4
Physical activity
Accelerometry
Time frame
Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: