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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD117197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Oklahoma | OTHER |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced physical activity | Experimental | Participants in this group will be encouraged to engage in daily physical activity |
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| Control group | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Altered breast milk lipidome | Milk composition measured through lipidomics | 8 weeks |
| Altered breast milk metabolome | Human milk composition measured via metabolomics | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months, and 12 months |
| Infant body mass index (BMI) |
| Measure | Description | Time Frame |
|---|---|---|
| Infant brown adipose tissue anatomy | MRI measurement of brown adipose tissue (BAT) volume and distribution | 2 months |
| Heat production | Infant Infrared Thermography to measure brown adipose tissue activity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elvira M Isganaitis, MD, MPH | Contact | 617-309-4554 | elvira.isganaitis@joslin.harvard.edu | |
| Study Coordinator | Contact | 857-289-3455 | PeaBaBy@joslin.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Body mass index (BMI) z-score for age and sex, usual range [-4,4]; lower BMI z-score represents lower adiposity |
| 3 months, 6 months, and 12 months |
| Infant resting metabolic rate | Infant Resting Metabolic Rate | 3 months of age |
| 1 month and 3 months |
| Oklahoma University College of Medicine | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D005247 | Feeding Behavior |