- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02217462
Pregnancy Eating Attributes Study (PEAS)
26. februar 2020 oppdatert av: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Studieoversikt
Status
Fullført
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
458
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- UNC Hospitals Obstetrics Clinic; Timberlylne Obstetrics & Gynecology Clinic
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 44 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Gravide kvinner
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Body weight
Tidsramme: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
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<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; delivery; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
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Dietary intake
Tidsramme: <12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
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<12 weeks pregnancy; 16-22 weeks pregnancy; 28-32 weeks pregnancy; 4-6 weeks postpartum; 6 months postpartum; 1 year postpartum
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Tonja R. Nansel, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cummings 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.
- Cummings 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.
- Temmen 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.
- Schwedhelm 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.
- Betts 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.
- Nansel 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.
- Lipsky 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.
- Lipsky 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.
- Hill 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.
- Nansel 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2014
Primær fullføring (Faktiske)
1. juni 2018
Studiet fullført (Faktiske)
1. juni 2018
Datoer for studieregistrering
Først innsendt
13. august 2014
Først innsendt som oppfylte QC-kriteriene
13. august 2014
Først lagt ut (Anslag)
15. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HHSN275201300015C
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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