Pregnancy Eating Attributes Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Body Weight Body Weight Changes Gestational Weight Gain Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

Body weight

Time frame: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
Dietary intake

Time frame: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

The Emmes Company, LLC
University of North Carolina, Chapel Hill

Registry information

Official study title

Diet, Obesity, and Weight Change in Pregnancy

Acronym: PEAS

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Aug 15, 2014
Registry last updated: Feb 28, 2020

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.

Completed