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NCT Number: NCT07467694

Postnatal Exercise to Activate Baby's Brown Fat

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active group

Behavioral

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.

Primary outcomes

  1. Altered breast milk lipidome

    Time frame: 8 weeks

    Milk composition measured through lipidomics

  2. Altered breast milk metabolome

    Time frame: 8 weeks

    Human milk composition measured via metabolomics

Secondary outcomes

  1. Infant body composition

    Time frame: 3 months, 6 months, and 12 months

    Infant 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.

  2. Infant body mass index (BMI)

    Time frame: 3 months, 6 months, and 12 months

    Body mass index (BMI) z-score for age and sex, usual range [-4,4]; lower BMI z-score represents lower adiposity

  3. Infant resting metabolic rate

    Time frame: 3 months of age

    Infant Resting Metabolic Rate

Other outcomes

  1. Infant brown adipose tissue anatomy

    Time frame: 2 months

    MRI measurement of brown adipose tissue (BAT) volume and distribution

  2. Heat production

    Time frame: 1 month and 3 months

    Infant Infrared Thermography to measure brown adipose tissue activity

Study contacts

Contact information is provided by the study sponsor or research team.

Elvira M Isganaitis, MD, MPH

CONTACT

[email protected]

617-309-4554

Study Coordinator

CONTACT

[email protected]

857-289-3455

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • National Institutes of Health (NIH)
  • University of Oklahoma

Registry information

Official study title

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

Acronym: PEABaBy

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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