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Pregnancy Eating Attributes Study (PEAS)

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ClinicalTrials.gov Identifier: NCT02217462
Recruitment Status : Recruiting
First Posted : August 15, 2014
Last Update Posted : August 7, 2017
Sponsor:
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)

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.

Condition or disease
Pregnancy

Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diet, Obesity, and Weight Change in Pregnancy
Study Start Date : October 2014
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Group/Cohort
Pregnant women



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Serum Plasma White and red blood cells Urine Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217462


Contacts
Contact: Karen Dorman, RN, MS 919-966-2550 kdorman@med.unc.edu

Locations
United States, North Carolina
UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic Recruiting
Chapel Hill, North Carolina, United States, 27514
Principal Investigator: Myles S. Faith, PhD         
Principal Investigator: Anna Maria Siega-Riz, PhD         
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
The EMMES Corporation
Investigators
Principal Investigator: Tonja R. Nansel, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT02217462     History of Changes
Other Study ID Numbers: HHSN275201300015C
First Posted: August 15, 2014    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: October 2015

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
pregnancy
gestational weight gain
dietary intake
food reward