PrepareD: Post-delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
Study Details
Study Description
Brief Summary
The goal of PrepareD is to examine whether the prepregnancy weight-loss intervention administered during the Prepare trial [NCT02346162] has an influence in the postnatal period. PrepareD is a cohort study (no intervention) that will address new specific aims through one in-person visit with mothers and children, dietary recalls, actigraphy, and the use of medical record weights. The goal is to collect data when the child is 3 years old. However, due to the COVID-19 pandemic, the investigators expanded the data collection window in order to collect data up to when the child is 5 years old. The investigators hypothesize that intervening on women before pregnancy is the key to breaking the multigenerational cycle of obesity.
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Study Design
Outcome Measures
Primary Outcome Measures
- Child body mass index (BMI) from birth up to 5 years of age [Birth up to 5 years of age]
All child weights, lengths (before age 2), and heights (after age 2) recorded in the electronic medical record (EMR) between delivery and up to 5 years of age will be collected. Child weight and height between 3 years 0 months of age up until 5 years of age will be measured at an in-person research visit. Weight in kilograms (kg) and height in meters (m) will be combined to report BMI in kg/m^2.
- Mother postpartum weight retention (PPWR) in pounds at 5 weeks and 1 year postpartum [5 weeks and 1 year after delivery]
All weights recorded for the mother in the EMR between delivery and up to 5 weeks and 1 year postpartum will be collected. PPWR at 5 weeks and 1 year after delivery will be obtained by subtracting mother's 5-week postpartum weight (in lbs) and 1-year postpartum weight (in lbs) from mother's weight (in lbs) at delivery, respectively.
Secondary Outcome Measures
- Healthy Eating Index (HEI) score for mother and child [At study visit, when child is 3-4 years of age]
Mother and child dietary data will be collected via dietary recalls following the study visit in order to calculate HEI total and component scores for mother and child.
- Daily activity level for mother and child [At study visit, when child is 3-4 years of age]
Mother and child activity level will be collected via actigraphy.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mother must be a Prepare [NCT02346162] participant who has experienced a viable pregnancy during the Prepare trial
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Child must be the first viable offspring born to a Prepare participant after consent into the Prepare study
Exclusion Criteria: None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Center for Health Research | Portland | Oregon | United States | 97227 |
Sponsors and Collaborators
- Kaiser Permanente
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Penn State University
Investigators
- Principal Investigator: Erin S LeBlanc, MD, MPH, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5R01DK125348
- 5R01DK125348