Mother Infant Nutrition Study

NCT04132310 | Enrolling By Invitation

• 1 other identifier: R00HD086304
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

Early life influences (including the intrauterine environment, birth weight, and early postnatal growth) shape subsequent weight trajectories and future chronic disease risk. The MINT study will evaluate whether maternal fat mass changes are associated with specific maternal weight trajectories during pregnancy, and with neonatal adiposity at birth. The study is a prospective observational cohort currently enrolling women in early pregnancy,and following mothers and infants after birth.

Conditions

Pregnancy Related; Infant Development

Keywords

Pregnancy; body composition; infant adiposity

Outcome Measures

Primary Outcomes (2)

• Maternal fat mass changes during pregnancy and postpartum

  Mother's fat mass at 14 weeks, 24 weeks, and 35 weeks gestation, and up to 24-months postpartum as a continuous variable. This will be ascertained through MRI and DXA.

  14, 24, 35 weeks gestation, and up to 24-months postpartum

• Infant percent fat at birth

  Infant percent fat at birth as a continuous variable. This will be ascertained through neonatal skinfolds and anthropometry.

  24-72 hours after birth

Secondary Outcomes (3)

• Maternal weight trajectories during pregnancy and postpartum

  Weekly after enrollment (up to 6 weeks postpartum), biweekly 2 to 24 months postpartum

• Maternal regional adipose tissue during pregnancy and postpartum

  14, 24,35 weeks gestation, and up to 24-months postpartum

• Infant percent fat after birth

  1-week to 24-months

Study Arms (1)

MINT Participants

Up to 60 MINT maternal participant are linked with 60 infant participants, and 60 partner participants.

Other: N/A This is an observational study.

Interventions

N/A This is an observational study. OTHER

This is an observational study.

MINT Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We plan to recruit up to 60 pregnant women around 8-14 weeks gestation and will follow the 60 babies after birth. If the pregnant mother identifies a partner for the partner component, we will seek to enroll the partner in the study, and therefore, we estimate that we will enroll up to 60 partners.

You may qualify if:

• \<16 weeks gestation
• Age \>18 years old
• BMI \<35 kg/m2
• Width \<48 cm

You may not qualify if:

• Diabetes
• Claustrophobia
• Recent weight loss of \>5% of body weight before pregnancy
• Weight-loss related surgery
• Currently breastfeeding
• Smoking
• Presence of any mechanically or magnetically activated implants, or any other contraindication for MRI

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (2)

Health Discovery Building Biomedical Imaging Center

Austin, Texas, 78712, United States

Location

Dell Pediatric Research Institute

Austin, Texas, 78723, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal biospecimen samples collected: blood (serum and plasma), urine, microbiome, breastmilk, placenta, umbilical cord and cord blood. Infant biospecimen samples collected: saliva, meconium, transitional stool, fecal sample.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 18, 2019
• Study Start: August 21, 2019
• Primary Completion: December 3, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (2)