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This study will help researchers learn more about how babies respond to bottle nipples with larger or smaller holes. Researchers guess that infants of mothers with obesity who did not lose weight prior to pregnancy will have the greatest Suck Effect on the challenging compared with the typical nipple.
The researchers will recruit babies from the original cohort in the PLAN study (NCT03244722), regardless of which arms they participated in. However, the researchers will test the study arms from the original PLAN study for effects on the study's dependent variables. Their between-subjects arms included Pre-pregnancy obesity with intensive weight loss intervention, pre-pregnancy obesity with standard of care intervention, and pre-pregnancy healthy weight with no intervention. So, although the researchers are not assigning babies to any arms, their original assignment will still be assessed the study analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nipple order 1 | Experimental | First the typical nipple and then challenging nipple |
|
| Nipple order 2 | Experimental | First the challenging nipple and then the typical nipple |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Typical Nipple | Behavioral | Infants are fed their typical milk/formula by their caregiver when hungry, one feeding with their typical nipple. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suck effect | Sucking will be measured with the NFANT® Feeding Solution | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sucking pressure | Sucking will be measured with the NFANT® Feeding Solution | Up to 6 weeks |
| Sucking frequency | Sucking will be measured with the NFANT® Feeding Solution |
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To be eligible to participate in this study...
Mother
-Current or previous participation in the PLAN study resulting in a live birth.
Child
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Crandall, PhD | University of Michigan | Principal Investigator |
| Julie Lumeng, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
The researchers may consider sharing data but hesitate due to difficulties de-identifying data of small samples. Please contact the study team if you have questions.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D018730 | Infant Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Order of nipple size use is counter-balanced, caregivers are blind to nipple size and amount of milk in the bottle (i.e., the bottle is covered) to minimize their influence over the infant's consumption. Research assistants will not be blind to nipple size as they will need to set the bottles ups for the mothers.
| Challenging Nipple | Behavioral | Infants are fed with a smaller sized nipple (i.e. with a smaller aperture, slowing the rate of milk delivery). |
|
| Up to 6 weeks |
| Milk/Formula intake | Up to 6 weeks |
| Milk/Formula consumption rate | Up to 6 weeks |
| Number of Feedings Over 24 Hours | Up to 6 weeks |
| Total Hours of Sleep per 24 Hours within 24 hours of intervention | Up to 6 weeks |
| Total Night Wake-ups within 24 hours of intervention | Up to 6 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002652 | Child Behavior |
| D001519 | Behavior |