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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| University of Pennsylvania | OTHER |
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Using retrospective data from the Vanderbilt University Medical Center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age.
The investigators are extracting de-identified retrospective data from the Vanderbilt University Medical Center electronic health record for mother-child pairs. From this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life. Included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mother-Child | Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. |
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| Measure | Description | Time Frame |
|---|---|---|
| Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life | Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles. | first 5 years of child's life |
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Inclusion Criteria:
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Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
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| Name | Affiliation | Role |
|---|---|---|
| Bryan Shepherd, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mother-Child | Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Mother-child pairs meeting inclusion criteria, mothers and children are reported individually.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mother-Child | Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life | Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles. | Posted | Count of Participants | Participants | first 5 years of child's life |
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Retrospective observational study; not applicable
Retrospective observational study; not applicable. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mother-Child | Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians. All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. |
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This was a retrospective observational study, and subject to all of the usual challenges with that type of data (e.g., confounding and measurement error). The data provided here are extracted from the electronic health record and may be prone to errors. We performed an extensive chart review for a subset of 996 mother-child records and incorporated these validated data into analyses using statistical methods that account for measurement error.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Shepherd | Vanderbilt University Medical Center | 615-343-3496 | bryan.shepherd@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2020 | Aug 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| years |
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| Sex: Female, Male | Sex is reported separately for children and mothers. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |