Pregnancy RelatedMINTNCT04132310
Mother Infant Nutrition Study
An observational study of Pregnancy Related and Infant Development, run by University of Texas at Austin at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Infant Development
- What is being tested?
- N/A This is an observational study.
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2019to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- <16 weeks gestation
- Age >18 years old
- BMI <35 kg/m2
- Width <48 cm
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Health Discovery Building Biomedical Imaging Center
Austin, Texas, 78712
Dell Pediatric Research Institute
Austin, Texas, 78723
About this study
Official title: Pregnancy Weight Trajectories and Offspring Adiposity
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.
Read the detailed description
The Institute of Medicine (IOM) recommendations were established with limited evidence showing how the pattern of weight gain is associated with short-and long-term health of mothers and their children. Previous studies evaluated the impact of overall gestational weight gain pattern across gestation using latent class analysis and others have evaluated maternal weight change pattern-by trimester or early/late pregnancy-on offspring size and adiposity. However, it remains unclear if there are weight gain trajectories or specific periods of weight gain that are associated with greater adiposity in offspring, and whether effects persist across the life course.
The MINT study will expand our understanding of determinants that are influencing maternal weight trajectories, including race/ethnicity, prepregnancy BMI and parity. Although many factors are well-established determinants of pregnancy weight gain, such as prepregnancy BMI and parity, there is limited understanding of whether these factors and others, such as maternal diet, race, psychosocial health or socio-economic status, influence the overall pattern of pregnancy weight gain and the IOM has called for research in this area. This knowledge is essential for providing personalized clinical recommendations for weight gain monitoring and to develop interventions to support healthy weight gain that optimizes health outcomes for mother and child.
This study is an observational, prospective cohort design, and will recruit up to 60 volunteers with singleton gestations of BMI 18.5-35. The mothers' will be assessed at 14-15, 24-25, and 35 weeks of pregnancy, and at 6 weeks post-delivery. Additional measurements may also be collected at 6-, 12-, and 24-months postpartum. The measurements will include anthropometry (weight, height, circumferences, and skin fold thicknesses), and whole body magnetic resonance imaging (MRI) and/or dual-energy X-ray absorptiometry (DXA). The infants' measurements will be anthropometry at birth (2-3 days), and approximately 1 and 6 weeks. Additional measurements may also be collected at 6-, 12-, and 24-months. Infants will also undergo air displacement plethysmography (PeaPod) at approximately 1 week and 6 weeks, and potentially DXA at 12- and 24-months. Biospecimen samples will be collected, including: maternal serum, plasma, urine, microbiome, breastmilk, placenta, umbilical cord and cord blood, infant meconium and stool, and infant saliva. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry). Other data to be collected include questionnaires on quality of life, socio-economic status, health behaviors and intentions. If the woman identifies a partner, the partner will be invited to complete questionnaires on health, health behaviors and anthropometry measures.
- Conditions
- Pregnancy Related, Infant Development
- Being tested
- N/A This is an observational study.
- Keywords
- Pregnancy, body composition, infant adiposity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A This is an observational study.Other
This is an observational study.
| Study group | Role | What they receive |
|---|---|---|
| MINT Participants | Up to 60 MINT maternal participant are linked with 60 infant participants, and 60 partner participants. Receives: Other: N/A This is an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24-72 hours after birth
Secondary outcomes (3)
Maternal weight trajectories during pregnancy and postpartum
Mother's weekly weights will be modeled using trajectory modeling as a continuous variable.
Measured: Weekly after enrollment (up to 6 weeks postpartum), biweekly 2 to 24 months postpartum
Maternal regional adipose tissue during pregnancy and postpartum
Mother's weight at 14 weeks, 24 weeks, and 35 weeks gestation, and up to 24-months postpartum, as a continuous variable. This will be ascertained through anthropometry, DXA, and MRI.
Measured: 14, 24,35 weeks gestation, and up to 24-months postpartum
Infant percent fat after birth
Infant percent fat at 1-week, 6-weeks, 6-months, 12-months, and 24-months old as a continuous variable. This will be ascertained through anthropometry, PeaPod, and DXA.
Measured: 1-week to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start21 Aug 2019
- Primary completion3 Dec 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Widen, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132310
- Sponsor's protocol ID
- R00HD086304
- Acronym
- MINT
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will only be shared with individuals who are collaborating with the research team on this study; these investigators will be added to the IRB or only provided with a limited deidentified dataset. The data will not be destroyed.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Weight Trajectories and Offspring Adiposity
- ClinicalTrials.gov ID
- NCT04132310
- Acronym / sponsor ID
- MINT / R00HD086304
- Conditions
- Pregnancy Related, Infant Development
- Keywords
- Pregnancy, body composition, infant adiposity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Institute of Medicine (IOM) recommendations were established with limited evidence showing how the pattern of weight gain is associated with short-and long-term health of mothers and their children. Previous studies evaluated the impact of overall gestational weight gain pattern across gestation using latent class analysis and others have evaluated maternal weight change pattern-by trimester or early/late pregnancy-on offspring size and adiposity. However, it remains unclear if there are weight gain trajectories or specific periods of weight gain that are associated with greater adiposity in offspring, and whether effects persist across the life course.
The MINT study will expand our understanding of determinants that are influencing maternal weight trajectories, including race/ethnicity, prepregnancy BMI and parity. Although many factors are well-established determinants of pregnancy weight gain, such as prepregnancy BMI and parity, there is limited understanding of whether these factors and others, such as maternal diet, race, psychosocial health or socio-economic status, influence the overall pattern of pregnancy weight gain and the IOM has called for research in this area. This knowledge is essential for providing personalized clinical recommendations for weight gain monitoring and to develop interventions to support healthy weight gain that optimizes health outcomes for mother and child.
This study is an observational, prospective cohort design, and will recruit up to 60 volunteers with singleton gestations of BMI 18.5-35. The mothers' will be assessed at 14-15, 24-25, and 35 weeks of pregnancy, and at 6 weeks post-delivery. Additional measurements may also be collected at 6-, 12-, and 24-months postpartum. The measurements will include anthropometry (weight, height, circumferences, and skin fold thicknesses), and whole body magnetic resonance imaging (MRI) and/or dual-energy X-ray absorptiometry (DXA). The infants' measurements will be anthropometry at birth (2-3 days), and approximately 1 and 6 weeks. Additional measurements may also be collected at 6-, 12-, and 24-months. Infants will also undergo air displacement plethysmography (PeaPod) at approximately 1 week and 6 weeks, and potentially DXA at 12- and 24-months. Biospecimen samples will be collected, including: maternal serum, plasma, urine, microbiome, breastmilk, placenta, umbilical cord and cord blood, infant meconium and stool, and infant saliva. Data will be collected regarding mothers' dietary intake and physical activity (questionnaires and accelerometry). Other data to be collected include questionnaires on quality of life, socio-economic status, health behaviors and intentions. If the woman identifies a partner, the partner will be invited to complete questionnaires on health, health behaviors and anthropometry measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MINT Participants | – | Other: N/A This is an observational study.Up to 60 MINT maternal participant are linked with 60 infant participants, and 60 partner participants. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- <16 weeks gestation
- Age >18 years old
- BMI <35 kg/m2
- Width <48 cm
Key exclusion criteria (7 listed)
- Diabetes
- Claustrophobia
- Recent weight loss of >5% of body weight before pregnancy
- Weight-loss related surgery
- Currently breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A This is an observational study.This is an observational study. | Other | MINT Participants |
Primary outcome
Maternal fat mass changes during pregnancy and postpartum
Time frame: 14, 24, 35 weeks gestation, and up to 24-months 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.
Infant percent fat at birth
Time frame: 24-72 hours after birth
Infant percent fat at birth as a continuous variable. This will be ascertained through neonatal skinfolds and anthropometry.
3 secondary outcomes
Maternal weight trajectories during pregnancy and postpartum
Time frame: Weekly after enrollment (up to 6 weeks postpartum), biweekly 2 to 24 months postpartum
Maternal regional adipose tissue during pregnancy and postpartum
Time frame: 14, 24,35 weeks gestation, and up to 24-months postpartum
Infant percent fat after birth
Time frame: 1-week to 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided. Data will only be shared with individuals who are collaborating with the research team on this study; these investigators will be added to the IRB or only provided with a limited deidentified dataset. The data will not be destroyed.
Related trials for Pregnancy Related
RecruitingPhase 2
E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers
Cervical Cancer, Throat Cancer
RecruitingPhase 3
A Study to Find Out if BI 764198 Helps Adults and Adolescents With a Kidney Condition Called Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental Glomerulosclerosis
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 1/2
E7 T-cell Receptor (TCR) -T Cell Induction Therapy for Locoregionally Advanced HPV-associated Cancers
HPV-Associated Cervical Carcinoma, HPV-Related Carcinoma
Recruiting
PTSD Screening in Pregnant Black Women
Pregnancy Early, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Infant Development, run by University of Texas at Austin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal fat mass changes during pregnancy and postpartum (time frame: 14, 24, 35 weeks gestation, and up to 24-months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.