Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas

NCT07477106 | Not Yet Recruiting

• 1 other identifier: 299710
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Maternal Nutrition; Infant Nutrition; Pediatric Nutrition; Maternal Health

Outcome Measures

Primary Outcomes (3)

• Maternal dietary intake

  24 hour dietary recall using ASA24

  Third trimester of pregnancy and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 months postpartum

• Child dietary pattern

  24 hour recall using NDSR

  0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month of age

• Breastfeeding outcomes

  Exclusivity, duration and mixed feeding

  0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum

Secondary Outcomes (4)

• Maternal weight

  Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum

• Human milk composition

  0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum or as long as lactating

• Blood pressure

  Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 month postpartum

• Physical activity

  Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 months postpartum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

human milk, stool and urine

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)