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Pregnancy Eating Attributes Study (PEAS)

This study is currently recruiting participants.
Verified October 2015 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02217462
First Posted: August 15, 2014
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of North Carolina, Chapel Hill
The EMMES Corporation
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 13, 2014
August 15, 2014
August 7, 2017
October 2014
July 2018   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT02217462 on ClinicalTrials.gov Archive Site
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Pregnancy Eating Attributes Study
Diet, Obesity, and Weight Change in Pregnancy
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Serum Plasma White and red blood cells Urine Stool
Non-Probability Sample
PEAS is a prospective observational study of N=450 women without evidence of psychiatric or eating disorders, recruited in early pregnancy (≤12 weeks), targeting N=150 in each weight status group: normal weight (BMI 18.5-24.9), overweight (BMI 25-29.9) and obese (BMI >=30). Women will be followed through pregnancy and until 1 year postpartum, along with their infants from birth to 1 year, with collection of blood, stool, and urine specimens, previous and current medical information, dietary intake and eating behaviors, anthropometrics, and demographic information.
Pregnancy
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Pregnant women
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
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July 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 44 Years   (Adult)
No
Contact: Karen Dorman, RN, MS 919-966-2550 kdorman@med.unc.edu
United States
 
 
NCT02217462
HHSN275201300015C
No
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of North Carolina, Chapel Hill
  • The EMMES Corporation
Principal Investigator: Tonja R. Nansel, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2015