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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06067126
Acronym
PrepareD
Enrollment
154
Registered
2023-10-04
Start date
2019-04-03
Completion date
2024-03-12
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Disorders, Obese, Overweight, Postpartum

Keywords

Wellness/Behavior Change

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.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Penn State University
CollaboratorOTHER
Kaiser Permanente
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mother postpartum weight retention (PPWR) in pounds at 5 weeks and 1 year postpartum5 weeks and 1 year after deliveryAll 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.
Child body mass index (BMI) from birth up to 5 years of ageBirth up to 5 years of ageAll 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.

Secondary

MeasureTime frameDescription
Healthy Eating Index (HEI) score for mother and childAt study visit, when child is 3-4 years of ageMother 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 childAt study visit, when child is 3-4 years of ageMother and child activity level will be collected via actigraphy.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026