Pregnancy Eating Attributes Study

Pregnancy Clinical Trial

— PEAS  

Official title:

Diet, Obesity, and Weight Change in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217462
• Other study ID #: HHSN275201300015C
• Status: Completed
• Start date: October 2014
• Est. completion date: June 2018

Study information

• Verified date: February 2020
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
United States	UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	The Emmes Company, LLC, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight		<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
Primary	Dietary intake		<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum