PrepareD: Examining Post-Delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kaiser Permanente
- Enrollment
- 154
- Locations
- 1
- Primary Endpoint
- Child body mass index (BMI) from birth up to 5 years of age
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Mother must be a Prepare [NCT02346162] participant who has experienced a viable pregnancy during the Prepare trial
- •Child must be the first viable offspring born to a Prepare participant after consent into the Prepare study
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Child body mass index (BMI) from birth up to 5 years of age
Time Frame: 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
Time Frame: 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 Outcomes
- Healthy Eating Index (HEI) score for mother and child(At study visit, when child is 3-4 years of age)
- Daily activity level for mother and child(At study visit, when child is 3-4 years of age)