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

Overweight Clinical Trial

— PrepareD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06067126
• Other study ID #: 5R01DK125348
• Secondary ID: 5R01DK125348
• Status: Completed
• Start date: April 3, 2019
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolic Disorders
• Obese
• Overweight
• Postpartum
• Weight Loss

Locations

Country	Name	City	State
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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