Postnatal Exercise to Activate Baby's Brown Fat
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active group.
- Who it may be relevant to
- Registry conditions: Childhood Obesity Prevention, Childhood Obesity, Physical Activity, Lactation. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk
Overview
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
- Behavioral Active 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.
Primary outcome measures
- Altered breast milk lipidome [Time frame: 8 weeks]
- Altered breast milk metabolome [Time frame: 8 weeks]
Secondary outcome measures (3)
- Infant body composition [Time frame: 3 months, 6 months, and 12 months]
- Infant body mass index (BMI) [Time frame: 3 months, 6 months, and 12 months]
- Infant resting metabolic rate [Time frame: 3 months of age]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Joslin Diabetes Center — Boston
- Oklahoma University College of Medicine — Oklahoma City
Identifiers
NCT: NCT07467694 · STUDY00000313 · R01HD117197