Mother Infant Nutrition Study

Pregnancy Related Clinical Trial

— MINT  

Official title:

Pregnancy Weight Trajectories and Offspring Adiposity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04132310
• Other study ID #: R00HD086304
• Status: Enrolling by invitation
• Start date: August 21, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: December 31, 2025
• Est. primary completion date: December 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. <16 weeks gestation

2. Age >18 years old

3. BMI <35 kg/m2

4. Width <48 cm

Exclusion Criteria:

1. Diabetes

2. Claustrophobia

3. Recent weight loss of >5% of body weight before pregnancy

4. Weight-loss related surgery

5. Currently breastfeeding

6. Smoking

7. Presence of any mechanically or magnetically activated implants, or any other contraindication for MRI

Related Conditions & MeSH terms

• Infant Development
• Pregnancy Related

Intervention

Other:
• N/A This is an observational study.
This is an observational study.

Locations

Country	Name	City	State
United States	Dell Pediatric Research Institute	Austin	Texas
United States	Health Discovery Building Biomedical Imaging Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Maternal weight trajectories during pregnancy and postpartum	Mother's weekly weights will be modeled using trajectory modeling as a continuous variable.	Weekly after enrollment (up to 6 weeks postpartum), biweekly 2 to 24 months postpartum
Secondary	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.	14, 24,35 weeks gestation, and up to 24-months postpartum
Secondary	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.	1-week to 24-months