About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Active group
BehavioralFor 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.
Treatment groups
Trial outcomes
Primary outcomes
Altered breast milk lipidome
Milk composition measured through lipidomics
Altered breast milk metabolome
Human milk composition measured via metabolomics
Secondary outcomes
Infant body composition
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.
Infant body mass index (BMI)
Body mass index (BMI) z-score for age and sex, usual range \[-4,4\]; lower BMI z-score represents lower adiposity
Infant resting metabolic rate
Infant Resting Metabolic Rate
Other outcomes
Infant brown adipose tissue anatomy
MRI measurement of brown adipose tissue (BAT) volume and distribution
Heat production
Infant Infrared Thermography to measure brown adipose tissue activity
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joslin Diabetes Center
Lead sponsor
University of Oklahoma
Collaborator
National Institutes of Health (NIH)
Collaborator