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

Completed

• Conditions: Overweight; Obese; Postpartum; Metabolic Disorders

• Registration Number: NCT06067126
• Lead Sponsor: Kaiser Permanente

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-03
• Study First Submitted: 2023-08-13
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-04
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 154

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Kaiser Permanente Center for Health Research; 🇺🇸 Portland, Oregon, United States