Postnatal Exercise to Activate Baby's Brown Fat

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJoslin Diabetes Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Enhanced physical activityExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Altered breast milk lipidome

Milk composition measured through lipidomics

Time frame
8 weeks
2

Altered breast milk metabolome

Human milk composition measured via metabolomics

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
3 months, 6 months, and 12 months
2

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

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

Infant resting metabolic rate

Infant Resting Metabolic Rate

Time frame
3 months of age

Other outcomes

1

Infant brown adipose tissue anatomy

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

Time frame
2 months
2

Heat production

Infant Infrared Thermography to measure brown adipose tissue activity

Time frame
1 month and 3 months

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