Pregnancy Eating Attributes Study

Completed

• Conditions: Pregnancy

• Registration Number: NCT02217462
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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 importance of food reward in the context of behavioral control and other related aspects of eating behavior, as well as weight-related biomedical, psychosocial and behavioral factors including genetics, physical activity, stress, sleep and depression. Four hundred and fifty women of varying baseline weight status will be enrolled early in pregnancy (before 12 weeks postpartum) and followed until 1 year postpartum. Assessments will occur at baseline (\<12 weeks postpartum), during pregnancy at 13-18 weeks gestation, 16-22 weeks, and 28-32 weeks, and postpartum at 4-6 weeks, 6 months, 9 months and 12 months. Measures will include assessments of food reward and related constructs, dietary intake, other health behaviors, and anthropometrics. Clinical data and biological specimens will be obtained. Infant anthropometrics and feeding practices will also be assessed. Primary exposures include aspects of food reward and behavioral control, which will be assessed in multiple ways to maximize information and utility. Primary outcomes include gestational weight gain, postpartum weight retention and dietary quality.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Study Start: 2014-10
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 458

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body weight	<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
Dietary intake	<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum

Trial Locations

Locations (1)

UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic; 🇺🇸 Chapel Hill, North Carolina, United States