Childhood Obesity PreventionPEABaByNCT07467694
Postnatal Exercise to Activate Baby's Brown Fat
A study testing Active group in people with Childhood Obesity Prevention and Childhood Obesity, run by Joslin Diabetes Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity Prevention, Childhood Obesity, Physical Activity
- What is being tested?
- Active group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2025to 1 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Elvira Isganaitis, MD, elvira.isganaitis@joslin.harvard.edu
- Recruiting
Oklahoma University College of Medicine
Oklahoma City, Oklahoma, 73104
Katy Duncan, katy-duncan@ou.edu
David Fields, PhD
About this study
Official title: Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk
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.
Read the 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.
- Conditions
- Childhood Obesity Prevention, Childhood Obesity, Physical Activity, Lactation, Breastfeeding, Pregnancy
- Being tested
- Active group
- Keywords
- Lactation, Breastfeeding, Breast milk, Pregnancy, Exercise
- Medical subject headings
- Pediatric Obesity, Motor Activity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced physical activity | Experimental | Participants in this group will be encouraged to engage in daily physical activity Receives: Behavioral: Active group |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered breast milk lipidome
Milk composition measured through lipidomics
Measured: 8 weeks
Altered breast milk metabolome
Human milk composition measured via metabolomics
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 3 months, 6 months, and 12 months
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
Measured: 3 months, 6 months, and 12 months
Infant resting metabolic rate
Infant Resting Metabolic Rate
Measured: 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Dec 2025
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Obesity PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467694
- Sponsor's protocol ID
- STUDY00000313
- Other IDs
- R01HD117197
- Acronym
- PEABaBy
- Status last verified
- Mar 2026
- First submitted
- 17 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk
- ClinicalTrials.gov ID
- NCT07467694
- Acronym / sponsor ID
- PEABaBy / STUDY00000313
- Conditions
- Childhood Obesity Prevention, Childhood Obesity, Physical Activity, Lactation, Breastfeeding, Pregnancy
- Keywords
- Lactation, Breastfeeding, Breast milk, Pregnancy, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- University of Oklahoma, National Institutes of Health (NIH)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced physical activity | Experimental | Behavioral: Active groupParticipants in this group will be encouraged to engage in daily physical activity |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active groupFor 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. | Behavioural | Enhanced physical activity |
Primary outcome
Altered breast milk lipidome
Time frame: 8 weeks
Milk composition measured through lipidomics
Altered breast milk metabolome
Time frame: 8 weeks
Human milk composition measured via metabolomics
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active group in people with Childhood Obesity Prevention and Childhood Obesity, run by Joslin Diabetes Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvira M Isganaitis, MD, MPH (617-309-4554, elvira.isganaitis@joslin.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered breast milk lipidome (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.