PregnancyPEASNCT02217462
Pregnancy Eating Attributes Study
An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnancy
- How many people
- 458 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
- Conditions
- Pregnancy
- Keywords
- pregnancy, gestational weight gain, dietary intake, food reward
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
Dietary intake
Measured: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill, The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Tonja R. Nansel, PhD, Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217462
- Sponsor's protocol ID
- HHSN275201300015C
- Acronym
- PEAS
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2014
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Lipsky LM, Burger KS, Faith MS, Shearrer GE, Nansel TR. Eating in the absence of hunger is not associated with weight, self-reported eating behaviors, or well-being in pregnant adults: Prospective cohort study. PLoS One. 2025 Jun 24;20(6):e0325478. doi: 10.1371/journal.pone.0325478. eCollection 2025.
PubMed 40554514Cummings JR, Faith MS, Lipsky LM, Liu A, Mooney JT, Nansel TR. Prospective relations of maternal reward-related eating, pregnancy ultra-processed food intake and weight indicators, and feeding mode with infant appetitive traits. Int J Behav Nutr Phys Act. 2022 Aug 3;19(1):100. doi: 10.1186/s12966-022-01334-9.
PubMed 35922793Cummings JR, Lipsky LM, Schwedhelm C, Liu A, Nansel TR. Associations of ultra-processed food intake with maternal weight change and cardiometabolic health and infant growth. Int J Behav Nutr Phys Act. 2022 May 26;19(1):61. doi: 10.1186/s12966-022-01298-w.
PubMed 35619114Temmen CD, Lipsky LM, Faith MS, Nansel TR. Prospective relations between maternal emotional eating, feeding to soothe, and infant appetitive behaviors. Int J Behav Nutr Phys Act. 2021 Aug 11;18(1):105. doi: 10.1186/s12966-021-01176-x.
PubMed 34380499Schwedhelm C, Lipsky LM, Shearrer GE, Betts GM, Liu A, Iqbal K, Faith MS, Nansel TR. Using food network analysis to understand meal patterns in pregnant women with high and low diet quality. Int J Behav Nutr Phys Act. 2021 Jul 23;18(1):101. doi: 10.1186/s12966-021-01172-1.
PubMed 34301273Betts GM, Lipsky LM, Temmen CD, Siega-Riz AM, Faith MS, Nansel TR. Poorer mental health and sleep quality are associated with greater self-reported reward-related eating during pregnancy and postpartum: an observational cohort study. Int J Behav Nutr Phys Act. 2021 May 1;18(1):58. doi: 10.1186/s12966-021-01124-9.
PubMed 33933087Nansel TR, Lipsky LM, Faith M, Liu A, Siega-Riz AM. The accelerator, the brake, and the terrain: associations of reward-related eating, self-regulation, and the home food environment with diet quality during pregnancy and postpartum in the pregnancy eating attributes study (PEAS) cohort. Int J Behav Nutr Phys Act. 2020 Nov 23;17(1):149. doi: 10.1186/s12966-020-01047-x.
PubMed 33228724Lipsky LM, Burger KS, Faith MS, Shearrer GE, Nansel TR. Eating in the Absence of Hunger Is Related to Worse Diet Quality throughout Pregnancy. J Acad Nutr Diet. 2021 Mar;121(3):501-506. doi: 10.1016/j.jand.2020.09.037. Epub 2020 Nov 3.
PubMed 33158801Lipsky LM, Burger KS, Faith MS, Siega-Riz AM, Liu A, Shearrer GE, Nansel TR. Pregnant Women Consume a Similar Proportion of Highly vs Minimally Processed Foods in the Absence of Hunger, Leading to Large Differences in Energy Intake. J Acad Nutr Diet. 2021 Mar;121(3):446-457. doi: 10.1016/j.jand.2020.09.036. Epub 2020 Oct 24.
PubMed 33109504Hill C, Lipsky LM, Betts GM, Siega-Riz AM, Nansel TR. A Prospective Study of the Relationship of Sleep Quality and Duration with Gestational Weight Gain and Fat Gain. J Womens Health (Larchmt). 2021 Mar;30(3):405-411. doi: 10.1089/jwh.2020.8306. Epub 2020 Sep 18.
PubMed 32945728Nansel TR, Lipsky LM, Siega-Riz AM, Burger K, Faith M, Liu A. Pregnancy eating attributes study (PEAS): a cohort study examining behavioral and environmental influences on diet and weight change in pregnancy and postpartum. BMC Nutr. 2016;2:45. doi: 10.1186/s40795-016-0083-5. Epub 2016 Jul 15.
PubMed 28663822
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Obesity, and Weight Change in Pregnancy
- ClinicalTrials.gov ID
- NCT02217462
- Acronym / sponsor ID
- PEAS / HHSN275201300015C
- Conditions
- Pregnancy
- Keywords
- pregnancy, gestational weight gain, dietary intake, food reward
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- University of North Carolina, Chapel Hill, The Emmes Company, LLC
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | – |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Derived from this study: PubMed 40554514Lipsky LM, Burger KS, Faith MS, Shearrer GE, Nansel TR. Eating in the absence of hunger is not associated with weight, self-reported eating behaviors, or well-being in pregnant adults: Prospective cohort study. PLoS One. 2025 Jun 24;20(6):e0325478. doi: 10.1371/journal.pone.0325478. eCollection 2025.
- Derived from this study: PubMed 35922793Cummings JR, Faith MS, Lipsky LM, Liu A, Mooney JT, Nansel TR. Prospective relations of maternal reward-related eating, pregnancy ultra-processed food intake and weight indicators, and feeding mode with infant appetitive traits. Int J Behav Nutr Phys Act. 2022 Aug 3;19(1):100. doi: 10.1186/s12966-022-01334-9.
- Derived from this study: PubMed 35619114Cummings JR, Lipsky LM, Schwedhelm C, Liu A, Nansel TR. Associations of ultra-processed food intake with maternal weight change and cardiometabolic health and infant growth. Int J Behav Nutr Phys Act. 2022 May 26;19(1):61. doi: 10.1186/s12966-022-01298-w.
- Derived from this study: PubMed 34380499Temmen CD, Lipsky LM, Faith MS, Nansel TR. Prospective relations between maternal emotional eating, feeding to soothe, and infant appetitive behaviors. Int J Behav Nutr Phys Act. 2021 Aug 11;18(1):105. doi: 10.1186/s12966-021-01176-x.
- Derived from this study: PubMed 34301273Schwedhelm C, Lipsky LM, Shearrer GE, Betts GM, Liu A, Iqbal K, Faith MS, Nansel TR. Using food network analysis to understand meal patterns in pregnant women with high and low diet quality. Int J Behav Nutr Phys Act. 2021 Jul 23;18(1):101. doi: 10.1186/s12966-021-01172-1.
- Derived from this study: PubMed 33933087Betts GM, Lipsky LM, Temmen CD, Siega-Riz AM, Faith MS, Nansel TR. Poorer mental health and sleep quality are associated with greater self-reported reward-related eating during pregnancy and postpartum: an observational cohort study. Int J Behav Nutr Phys Act. 2021 May 1;18(1):58. doi: 10.1186/s12966-021-01124-9.
- Derived from this study: PubMed 33228724Nansel TR, Lipsky LM, Faith M, Liu A, Siega-Riz AM. The accelerator, the brake, and the terrain: associations of reward-related eating, self-regulation, and the home food environment with diet quality during pregnancy and postpartum in the pregnancy eating attributes study (PEAS) cohort. Int J Behav Nutr Phys Act. 2020 Nov 23;17(1):149. doi: 10.1186/s12966-020-01047-x.
- Derived from this study: PubMed 33158801Lipsky LM, Burger KS, Faith MS, Shearrer GE, Nansel TR. Eating in the Absence of Hunger Is Related to Worse Diet Quality throughout Pregnancy. J Acad Nutr Diet. 2021 Mar;121(3):501-506. doi: 10.1016/j.jand.2020.09.037. Epub 2020 Nov 3.
- Derived from this study: PubMed 33109504Lipsky LM, Burger KS, Faith MS, Siega-Riz AM, Liu A, Shearrer GE, Nansel TR. Pregnant Women Consume a Similar Proportion of Highly vs Minimally Processed Foods in the Absence of Hunger, Leading to Large Differences in Energy Intake. J Acad Nutr Diet. 2021 Mar;121(3):446-457. doi: 10.1016/j.jand.2020.09.036. Epub 2020 Oct 24.
- Derived from this study: PubMed 32945728Hill C, Lipsky LM, Betts GM, Siega-Riz AM, Nansel TR. A Prospective Study of the Relationship of Sleep Quality and Duration with Gestational Weight Gain and Fat Gain. J Womens Health (Larchmt). 2021 Mar;30(3):405-411. doi: 10.1089/jwh.2020.8306. Epub 2020 Sep 18.
- Derived from this study: PubMed 28663822Nansel TR, Lipsky LM, Siega-Riz AM, Burger K, Faith M, Liu A. Pregnancy eating attributes study (PEAS): a cohort study examining behavioral and environmental influences on diet and weight change in pregnancy and postpartum. BMC Nutr. 2016;2:45. doi: 10.1186/s40795-016-0083-5. Epub 2016 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonja R. Nansel, PhD principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217462, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.