Maternal Obesity, Breast Milk Composition, and Infant Growth
(MILK)
2 other identifiers
observational
2,050
1 country
2
Brief Summary
Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform among women, having been optimized through evolutionary time to provide adequate sole nutrition for the growing infant regardless of the environmental circumstances. However, recent evidence shows that breast milk is a highly complex fluid with significant inter-individual variation in hormonal and cytokine concentrations, human milk oligosaccharides (HMOs) and other features. Pervasive maternal obesity and gestational diabetes are evolutionarily novel conditions for the human species but little effort has yet been made to systematically examine how they are associated with breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, HMOs, or other features, or whether that variation relates to infant metabolic status. The objective of this study is to comprehensively assess the "lactational programming" hypothesis, that is, whether or not recently documented variation in breast-milk composition is related to both maternal and infant metabolic status. The central hypothesis is that a graded, dose-response relationship between maternal adiposity and GDM exists with adipocytokine concentrations, HMOs, and other features in breast milk and that the milk concentrations of these features are associated with altered body composition in their exclusively breast-fed offspring. The results of the study will be used to design interventions to reduce maternal weight during pregnancy and lactation and to augment lactation education materials to focus on the needs of breastfeeding women with obesity and GDM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 13, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
August 24, 2025
August 1, 2025
12.5 years
September 13, 2017
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Milk Composition Changes
Breastmilk hormone concentration changes
1-3 months post-partum
Secondary Outcomes (1)
Infant Body Composition Changes
0-6 months of age
Eligibility Criteria
(Minneapolis site): In the Twin Cities metro area, subjects will be recruited from patients who attend medical group clinics for Ob/Gyn care in their second trimester of pregnancy through the various means, including through the OB/GYN department of the University of Minneosta Medical School via letter and follow-up phone call for final screening. (Oklahoma City site): Recruitment in the OKC metro area will be through OUHSC Ob/Gyn clinic, and local private practice OB/GYN clinics during the second trimester, through the La Leche League, and public announcements.
You may qualify if:
- Pregnant females
- to 45 years of age at the time of delivery
- Pre-gravid BMI between 18.5 to 40 kg/m2
- Healthy pregnancy defined as \<3 days in hospital following delivery
- Report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3-months
- If parity \>1, report that they successfully breast fed a previous pregnancy for at least 3 months
- Singleton gestation
- Term pregnancy (gestational age \>37 but \<42 weeks)
- Infant birth weight \>2,500 grams but \<4,500 grams.
You may not qualify if:
- Alcohol consumption \>1 drink per week during pregnancy/lactation
- Tobacco consumption during pregnancy/lactation
- History/current Type I or II diabetes
- Inability to speak/understand English
- Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- HealthPartners Institutecollaborator
- University of Oklahomacollaborator
Study Sites (2)
University of Minnesota School of Public Health
Minneapolis, Minnesota, 55454, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
Sadr Dadres G, Whitaker KM, Haapala JL, Foster L, Smith KD, Teague AM, Jacobs DR Jr, Kharbanda EO, McGovern PM, Schoenfuss TC, Le LJ, Harnack L, Fields DA, Demerath EW. Relationship of Maternal Weight Status Before, During, and After Pregnancy with Breast Milk Hormone Concentrations. Obesity (Silver Spring). 2019 Apr;27(4):621-628. doi: 10.1002/oby.22409.
PMID: 30900412DERIVED
Related Links
Biospecimen
2 ml aliquots of breastmilk are stored for future chemical analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Fields, PhD
University of Oklahoma
- PRINCIPAL INVESTIGATOR
Ellen Demerath, PhD
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2017
First Posted
October 4, 2017
Study Start
July 1, 2014
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Within 6 months of funding end date
- Access Criteria
- Anyone who has access to the NIH/NICHD Data and Specimen Sharing Hub (DASH) will be able to access the IPD
As required by the NICHD, we will upload our clinical subject data and non-genomic milk specimen analyses to the NICHD Data and Specimen Hub (DASH). Data submitted to NICHD DASH will be individual-level research data that has been de-identified and is usable for secondary analysis. This will include maternal and infant demographics, diet intake data, clinical status information, body weight and growth data, body composition data, infant feeding and breastfeeding data, maternal physical activity and behavioral data, milk compositional data, and infant fecal microbiome data. All research data submitted to NICHD DASH will be accompanied by proper documentation including study protocol, data collection instruments, data dictionaries, and data de-identification methodology.