Trial Outcomes & Findings for Association Between Mother and Child Weight Gain: Statistical Methods With Validation (NCT NCT04174521)
NCT ID: NCT04174521
Last Updated: 2022-01-31
Results Overview
Obesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.
Recruitment status
COMPLETED
Target enrollment
20670 participants
Primary outcome timeframe
first 5 years of child's life
Results posted on
2022-01-31
Participant Flow
Participant milestones
| Measure |
Mother-Child
Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
|
|---|---|
|
Overall Study
STARTED
|
20670
|
|
Overall Study
COMPLETED
|
20670
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex is reported separately for children and mothers.
Baseline characteristics by cohort
| Measure |
Mother-Child
n=20670 Participants
Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.
|
|---|---|
|
Age, Continuous
Maternal Age at delivery
|
28 years
n=20670 Participants
|
|
Age, Continuous
Child Age at delivery
|
0 years
n=20670 Participants
|
|
Sex: Female, Male
Maternal sex · Female
|
10335 Participants
n=10335 Participants • Sex is reported separately for children and mothers.
|
|
Sex: Female, Male
Maternal sex · Male
|
0 Participants
n=10335 Participants • Sex is reported separately for children and mothers.
|
|
Sex: Female, Male
Child sex · Female
|
4887 Participants
n=10335 Participants • Sex is reported separately for children and mothers.
|
|
Sex: Female, Male
Child sex · Male
|
5448 Participants
n=10335 Participants • Sex is reported separately for children and mothers.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3082 Participants
n=20670 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17168 Participants
n=20670 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
420 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
154 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
Asian
|
1420 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4778 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
White
|
12778 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
More than one race
|
82 Participants
n=20670 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1458 Participants
n=20670 Participants
|
|
Region of Enrollment
United States
|
20670 participants
n=20670 Participants
|
PRIMARY outcome
Timeframe: first 5 years of child's lifeObesity of the child is defined as having a BMI-by-age classification greater than the 95th percentile based on the US CDC percentiles.
Outcome measures
| Measure |
Mother-Child
n=10335 Participants
Mothers-child pairs whose delivery occurred at VUMC and who are seen by Vanderbilt-affiliated physicians.
|
|---|---|
|
Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
|
1845 Participants
|
Adverse Events
Mother-Child
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place