- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477106
Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas
March 13, 2026 updated by: Arkansas Children's Hospital Research Institute
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
Status
Not yet recruiting
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
-
-
Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Research Institute
-
Contact:
- Audrey Martinez, PhD, RD
- Phone Number: 5013642785
- Email: martinezae@archildrens.org
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Contact:
- Email: andresaline@uams.edu
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Principal Investigator:
- Aline Andres, PhD, RD, CLC
-
-
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.
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