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

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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Key information

Conditions

Overweight Body Weight Metabolic Diseases Metabolic Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Postpartum Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Time frame: 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

Time frame: At study visit, when child is 3-4 years of age

Mother and child activity level will be collected via actigraphy.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Penn State University

Registry information

Official study title

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

Acronym: PrepareD

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Oct 4, 2023
Registry last updated: Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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