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Postnatal Exercise to Activate Baby's Brown Fat

Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07467694
Acronym
PEABaBy
Enrollment
200
Registered
2026-03-12
Start date
2025-12-01
Completion date
2030-07-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Childhood Obesity, Childhood Obesity Prevention, Exercise, Lactation, Physical Activity, Pregnancy

Keywords

Lactation, Breastfeeding, Breast milk, Pregnancy, Exercise

Brief summary

The purpose of this study is to learn how exercise and physical activity during pregnancy and after pregnancy may affect the composition of breastmilk. Certain changes in breast milk after exercise may have an impact on how infants use energy. Understanding this process may improve public health recommendations for exercise during and after pregnancy. This study can help investigators learn more about how maternal exercise patterns may affect body growth and obesity risk in infants who are breastfed. This research may help identify how different factors can influence healthy weight and early development in infants.

Detailed description

Epidemiological studies suggest that breastfeeding protects against risk of obesity, diabetes, asthma, and other childhood diseases. However, the specific compounds within breastmilk that are responsible for its protective effects are not fully understood. Moreover, prior work from this investigative team has shown that human milk composition varies substantially between individuals according to factors such as body mass index (BMI), diabetes status, diet, and physical activity. Gaining a better understanding of how modifiable risk factors may impact human milk composition would have the potential to identify strategies to enhance the health-promoting benefits of human milk. In this project, the investigators will study the impact of maternal exercise on human milk composition. The central hypothesis is that maternal exercise induces changes in breast milk metabolites and lipids that result in activation of infant brown fat, increased infant energy expenditure, and reduced obesity risk. The study will include assessments of habitual activity during pregnancy and the postpartum period, supervised bouts acute moderate exercise, as well as analysis of human milk composition, infant growth and body composition, and infant energy expenditure.

Interventions

BEHAVIORALActive group

For participants randomized to the Active group, there will be weekly phone calls with study staff during which step counts and exercise bouts from the previous week will be reviewed, and exercise goals for the following week will be gradually increased.

Sponsors

Joslin Diabetes Center
Lead SponsorOTHER
University of Oklahoma
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-45 y of age at the time of enrollment * Pre-gravid or first trimester BMI 18.5 -40 kg/m2 * Uncomplicated singleton pregnancy * Intention to exclusively breastfeed for \>3 months and, if parity \>1, that they successfully breastfed a previous pregnancy * Term pregnancy (gestational age 37 to \<42 weeks) * Infant with birth weight \>10th percentile of weight for gestational age

Exclusion criteria

* Any obstetric contra-indication to exercise at 1 month * Diagnosis of uncontrolled (HbA1c \>7%) type 1 or type 2 diabetes, or gestational diabetes managed with insulin * Intrauterine growth restriction * Pre-eclampsia or other pregnancy complications * Alcohol, cannabis or tobacco use * Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth * Major fetal anomalies * Musculoskeletal issues that would make exercise difficult

Design outcomes

Primary

MeasureTime frameDescription
Altered breast milk lipidome8 weeksMilk composition measured through lipidomics
Altered breast milk metabolome8 weeksHuman milk composition measured via metabolomics

Secondary

MeasureTime frameDescription
Infant body composition3 months, 6 months, and 12 monthsInfant body composition will be measured using air-displacement plethysmography (ADP; i.e., PeaPod) at 1 and 3-mo and by DXA at 6 and 12-mo: percentage fat, total fat mass.
Infant body mass index (BMI)3 months, 6 months, and 12 monthsBody mass index (BMI) z-score for age and sex, usual range \[-4,4\]; lower BMI z-score represents lower adiposity
Infant resting metabolic rate3 months of ageInfant Resting Metabolic Rate

Countries

United States

Contacts

CONTACTElvira M Isganaitis, MD, MPH
elvira.isganaitis@joslin.harvard.edu617-309-4554
CONTACTStudy Coordinator
PeaBaBy@joslin.harvard.edu857-289-3455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026