Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:50 AM
Study NCT ID:
NCT07467694
Status:
RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postnatal Exercise to Activate Baby's Brown Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005247', 'term': 'Feeding Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-11', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Infant brown adipose tissue anatomy', 'timeFrame': '2 months', 'description': 'MRI measurement of brown adipose tissue (BAT) volume and distribution'}, {'measure': 'Heat production', 'timeFrame': '1 month and 3 months', 'description': 'Infant Infrared Thermography to measure brown adipose tissue activity'}], 'primaryOutcomes': [{'measure': 'Altered breast milk lipidome', 'timeFrame': '8 weeks', 'description': 'Milk composition measured through lipidomics'}, {'measure': 'Altered breast milk metabolome', 'timeFrame': '8 weeks', 'description': 'Human milk composition measured via metabolomics'}], 'secondaryOutcomes': [{'measure': 'Infant body composition', 'timeFrame': '3 months, 6 months, and 12 months', 'description': '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.'}, {'measure': 'Infant body mass index (BMI)', 'timeFrame': '3 months, 6 months, and 12 months', 'description': 'Body mass index (BMI) z-score for age and sex, usual range \\[-4,4\\]; lower BMI z-score represents lower adiposity'}, {'measure': 'Infant resting metabolic rate', 'timeFrame': '3 months of age', 'description': 'Infant Resting Metabolic Rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lactation', 'Breastfeeding', 'Breast milk', 'Pregnancy', 'Exercise'], 'conditions': ['Childhood Obesity Prevention', 'Childhood Obesity', 'Physical Activity', 'Lactation', 'Breastfeeding', 'Pregnancy', 'Exercise']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 y of age at the time of enrollment\n* Pre-gravid or first trimester BMI 18.5 -40 kg/m2\n* Uncomplicated singleton pregnancy\n* Intention to exclusively breastfeed for \\>3 months and, if parity \\>1, that they successfully breastfed a previous pregnancy\n* Term pregnancy (gestational age 37 to \\<42 weeks)\n* Infant with birth weight \\>10th percentile of weight for gestational age\n\nExclusion Criteria:\n\n* Any obstetric contra-indication to exercise at 1 month\n* Diagnosis of uncontrolled (HbA1c \\>7%) type 1 or type 2 diabetes, or gestational diabetes managed with insulin\n* Intrauterine growth restriction\n* Pre-eclampsia or other pregnancy complications\n* Alcohol, cannabis or tobacco use\n* Known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding/growth\n* Major fetal anomalies\n* Musculoskeletal issues that would make exercise difficult'}, 'identificationModule': {'nctId': 'NCT07467694', 'acronym': 'PEABaBy', 'briefTitle': "Postnatal Exercise to Activate Baby's Brown Fat", 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'Impact of Acute Exercise and Habitual Physical Activity on Human Milk Composition and Childhood Obesity Risk', 'orgStudyIdInfo': {'id': 'STUDY00000313'}, 'secondaryIdInfos': [{'id': 'R01HD117197', 'link': 'https://reporter.nih.gov/quickSearch/R01HD117197', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enhanced physical activity', 'description': 'Participants in this group will be encouraged to engage in daily physical activity', 'interventionNames': ['Behavioral: Active group']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care'}], 'interventions': [{'name': 'Active group', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Enhanced physical activity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elvira Isganaitis, MD', 'role': 'CONTACT', 'email': 'elvira.isganaitis@joslin.harvard.edu'}], 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Katy Duncan', 'role': 'CONTACT', 'email': 'katy-duncan@ou.edu'}, {'name': 'David Fields, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oklahoma University College of Medicine', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'centralContacts': [{'name': 'Elvira M Isganaitis, MD, MPH', 'role': 'CONTACT', 'email': 'elvira.isganaitis@joslin.harvard.edu', 'phone': '617-309-4554'}, {'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'PeaBaBy@joslin.harvard.edu', 'phone': '857-289-3455'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}