Post-delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention

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.

Official Title
-----------------
PrepareD: Examining Post-Delivery Maternal-offspring Obesity and Metabolic Risk After a Prepregnancy Weight-loss Intervention

Conditions
-----------------
Overweight, Obese, Metabolic Disorders, Postpartum

Participation Criteria
=================
Eligibility Criteria
-----------------
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: None
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child body mass index (BMI) from 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. | Birth up to 5 years of age | 
| Mother postpartum weight retention (PPWR) in pounds at 5 weeks and 1 year postpartum | 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. | 5 weeks and 1 year after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthy Eating Index (HEI) score for mother and child | 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. | At study visit, when child is 3-4 years of age | 
| Daily activity level for mother and child | Mother and child activity level will be collected via actigraphy. | At study visit, when child is 3-4 years of age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wellness/Behavior Change