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Not yet recruiting NCT07477106

Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas

Observational Maternal Nutrition Infant Nutrition Pediatric Nutrition Maternal Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Maternal Nutrition, Infant Nutrition, Pediatric Nutrition, Maternal Health. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas - The Thrive Study

Overview

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.

Primary outcome measures

  • Maternal dietary intake [Time frame: Third trimester of pregnancy and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 months postpartum]
  • Child dietary pattern [Time frame: 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month of age]
  • Breastfeeding outcomes [Time frame: 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum]
Secondary outcome measures (4)
  • Maternal weight [Time frame: Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum]
  • Human milk composition [Time frame: 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum or as long as lactating]
  • Blood pressure [Time frame: Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum]
  • Physical activity [Time frame: Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 months postpartum]

Eligibility criteria

Inclusion criteria

  • At least 30 weeks pregnant
  • Ability to engage in study procedures throughout the first 12 months postpartum

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Arkansas Children's Research Institute — Little Rock

Identifiers

NCT: NCT07477106 · 299710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗