Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas

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

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.

Study Overview

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month of age
24 hour recall using NDSR
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
Exclusivity, duration and mixed feeding
0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight
Time Frame: Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18 and 24 month postpartum
Smart scale
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
macronutrients, micronutrients and non-nutritive components
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
Smart device, at home collection
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
Accelerometry
Third trimester and 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 18, 24 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 299710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maternal Health

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