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

NCT06067126 | Completed

• 1 other identifier: 5R01DK125348
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese; Metabolic Disorders; Postpartum

Keywords

Wellness/Behavior Change

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for PrepareD will be recruited from the pool of women who consented to participate in the Prepare trial \[NCT02346162\]. The investigators expect to re-enroll around 180 Prepare mother-offspring pairs in the PrepareD study.

You may qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Penn State University: collaborator

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, stool

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erin S LeBlanc, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: October 4, 2023
• Study Start: April 3, 2019
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)