Status:
COMPLETED
Pregnancy Eating Attributes Study
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
University of North Carolina, Chapel Hill
The Emmes Company, LLC
Conditions:
Pregnancy
Eligibility:
FEMALE
18-44 years
Brief Summary
The primary purpose of this observational cohort study is to examine the role of "food reward" in maternal diet and weight change during pregnancy and postpartum. The study will further examine the im...
Eligibility Criteria
Inclusion
- Female confirmed pregnant \<12 weeks at screening
- Uncomplicated singleton pregnancy anticipated
- Age \>=18 and \<45 at screening
- Willingness to undergo study procedures and provide informed consent for her participation and assent for the baby's participation
- BMI \>=18.5 (to qualify as normal: 18.5-24.9; overweight 25-29.9; or obese : \>=30)
- Able to complete self-reported assessments in English
- Access to Internet with email to complete self-reported assessments
- Plan to deliver at UNC Hospital
- Plan to remain in the area for 1 year following delivery
Exclusion
- Pre-existing diabetes (type 1 or type 2)
- Multiple pregnancy
- Participant-reported eating disorder
- Any fetal anomaly requiring surgery with hospital admission following delivery (e.g. NTDs, gastroschisis, cardiac defects, Trisomy 21)
- Any medical condition contraindicating participation in the study such as chronic illnesses or use of medication that could affect diet or weight e.g. cancer, HIV, active renal disease, MI in the last 6 months, chronic steroid use, thyroid disease requiring medication, or autoimmune disease (rheumatoid arthritis, lupus, antiphospholipid antibody syndrome, scleroderma)
- Psychosocial condition contraindicating participation in the study such as bipolar, schizophrenia, major affective disorder, substance abuse.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT02217462
Start Date
October 1 2014
End Date
June 1 2018
Last Update
February 28 2020
Active Locations (1)
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1
UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic
Chapel Hill, North Carolina, United States, 27514