Mother Infant Nutrition Study

NCT ID: NCT04132310

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MINT Participants

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

N/A This is an observational study.

Intervention Type: OTHER

This is an observational study.

Interventions

N/A This is an observational study.

This is an observational study.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Widen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Discovery Building Biomedical Imaging Center

Austin, Texas, United States

Dell Pediatric Research Institute

Austin, Texas, United States

Countries

United States

Other Identifiers

R00HD086304

Identifier Type: NIH

Identifier Source: org_study_id

View Link