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Sleep and Tracking Effects in Pregnancy Study (STEP)

12. september 2022 opdateret af: University of North Carolina, Chapel Hill

Improving Perinatal Outcomes Through Activity and Sleep Tracking

Purpose: The investigators hypothesize that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women reduce their stress during pregnancy.

Participants: Pregnant women enrolled in prenatal care at the University of North Carolina who have a documented moderate or high level of perceived stress ( ≥ 14) and are at high risk for adverse pregnancy outcomes due to body mass index of ≥ 30 kg/m2 or history of gestational hypertension, preeclampsia, intrauterine growth restriction, or preterm birth <37 weeks' in a prior pregnancy.

Procedures: Women meeting inclusion criteria will be recruited through the University of North Carolina prenatal care clinics. They will be contacted for possible participation at regularly scheduled prenatal visits and/or ultrasound. They may also be contacted for possible participation by remote methods (e.g., Telehealth). Women who are enrolled will complete validated dietary, stress, sleep, and body image questionnaires. Enrolled women will then be randomized to receive standard obstetrical care or enhanced counseling. All participants will receive a wrist-based activity tracker. Maternal blood sample for biochemical markers of stress and gene expression will be obtained at the initial visit; a followup blood sample will be obtained later in pregnancy, and a small portion of the placenta saved at delivery. Maternal and neonatal outcomes will be compared between groups.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

During pregnancy, women regularly interact with healthcare professionals, an often untapped resource and opportune time to minimize stress and optimize weight gain, nutrition, and activity, positively impacting outcomes and lifelong health. The overarching hypothesis of this study is that a simple, personalized, smartphone-based activity intervention using a wrist-based activity tracker will help high risk pregnant women increase their activity level during pregnancy, reduce stress, and optimize gestational weight gain and biometric parameters. Importantly, the investigators propose that women can be engaged in care via a simple, personalized text-message based intervention.

Women will be enrolled early in pregnancy and followed prospectively. All women will receive a wrist-based activity tracker. Some women (those randomized to receive individualized counseling) will receive weekly text messages based on their activity and sleep in the prior week. Other women will not receive any specific instructions regarding activity level. The investigators will follow their outcomes prospectively. Biologic samples (including blood, urine, vaginal swabs, placental tissue) will be collected at enrollment and at delivery.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

250

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina
        • Kontakt:
          • Tracy Manuck, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 51 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • At high risk for adverse pregnancy outcomes, due to either body mass index ≥ 30 kg/m^2, or a prior history of preeclampsia, intrauterine growth restriction or preterm birth prior to 37 weeks' gestation in a previous pregnancy and a perceived stress score of >/= 14 (10-question scale)
  • Gestational age of 8.0 to 19.9 weeks' gestation using American College of Obstetricians and Gynecologists dating criteria (combination of ultrasound and menstrual dating, as available)
  • Current singleton viable intrauterine pregnancy. Spontaneous reduction of twin to singleton gestation is allowable provided it occurred prior to 14 weeks' gestation.
  • No structural abnormalities or aneuploidy
  • Ability to communicate in and provide consent in English
  • Maternal age 18 to 51 years of age
  • Owns smartphone compatible with wrist-based activity tracker (over 200 devices supported)

Exclusion Criteria:

  • Women pregnant with multifetal gestations
  • Women who have a medical condition where a modest increase in low-impact activity is contraindicated (at the discretion of the woman's treating physician)
  • Planned delivery prior to 36 weeks' of gestation
  • Unwilling to wear wrist-based activity tracker for at least 6 out of 7 days per week

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual care
Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.
Eksperimentel: Activity Intervention
Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .
Adfærdsmæssigt: Activity Intervention
After 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction in Perceived Maternal Stress
Tidsramme: through delivery, an average of 7 months per participant
Perceived stress score will be calculated using a validated 10-question stress scale; score = 14 indicates moderate stress
through delivery, an average of 7 months per participant
Proportion of women with adverse perinatal outcomes
Tidsramme: outcome will be ascertained at delivery
The investigators will define adverse pregnancy outcomes as a composite of preterm birth <37 weeks, intrauterine growth restriction, preeclampsia, and placental abruption; outcomes will be compared between randomization groups.
outcome will be ascertained at delivery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of activity goals met by personalized activity level group
Tidsramme: through delivery, an average of 7 months per participant
Proportion of weekly activity goals that were successfully met by women randomized to personalized activity group
through delivery, an average of 7 months per participant
Mean Daily steps
Tidsramme: through delivery, an average of 7 months per participant
Mean number of daily steps; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Median Daily steps
Tidsramme: through delivery, an average of 7 months per participant
median number of daily steps; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Mean 'Moderate' or greater physical activity
Tidsramme: through delivery, an average of 7 months per participant
Mean number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Median 'Moderate' or greater physical activity
Tidsramme: through delivery, an average of 7 months per participant
median number of weekly minutes of 'moderate' or 'intense' physical activity as registered by the wrist-based activity monitor; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Mean Nightly sleep minutes
Tidsramme: through delivery, an average of 7 months per participant
Mean number of sleep minutes per night; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Median Nightly sleep minutes
Tidsramme: through delivery, an average of 7 months per participant
median number of sleep minutes per night; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Median resting heart rate parameters
Tidsramme: through delivery, an average of 7 months per participant
The change in the median resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Mean Resting heart rate parameters
Tidsramme: through delivery, an average of 7 months per participant
The change in the mean resting heart rate level and nadir of the resting heart rate (in beats per minute), between enrollment and delivery ; amount will be compared between randomization groups.
through delivery, an average of 7 months per participant
Median Body composition change during study - total body water
Tidsramme: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
The change in median total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - total body water
Tidsramme: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
The change in mean total body water measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Median Body composition change during study - percent body fat
Tidsramme: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
The change in median percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Mean Body composition change during study - percent body fat
Tidsramme: through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
The change in mean percent body fat measurements between enrollment and re-assessment at 8 and 16 weeks (as applicable, if still pregnant) after enrollment will be compared between randomization groups.
through reassessment of body composition at 16 weeks after randomization, an average of 4 months per participant.
Gestational weight gain
Tidsramme: through delivery, an average of 7 months per participant
The amount of weight gained by each participant during pregnancy, in pounds. outcomes will be compared between randomization groups.
through delivery, an average of 7 months per participant
Gestational weight gain, per week after study enrollment
Tidsramme: through delivery, an average of 7 months per participant
The amount of weight gained per week by each participant, in pounds, between study enrollment and delivery. outcomes will be compared between randomization groups.
through delivery, an average of 7 months per participant
Proportion of women with gestational diabetes mellitus
Tidsramme: through delivery, an average of 7 months per participant.
The diagnosis of gestational diabetes mellitus during pregnancy, using standard criteria as set forth by American College of Obstetricians and Gynecologists. outcomes will be compared between randomization groups.
through delivery, an average of 7 months per participant.
Proportion of women with hypertensive complications of pregnancy
Tidsramme: through 6 weeks' postpartum, an average of 7 months per participant
The diagnosis of gestational hypertension, preeclampsia, or eclampsia, using standard American College of Obstetricians and Gynecologists diagnostic criteria. outcomes will be compared between randomization groups.
through 6 weeks' postpartum, an average of 7 months per participant

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Carolina, Chapel Hill

Efterforskere

  • Ledende efterforsker: Tracy A Manuck, MD, University of North Carolina, Chapel Hill

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. maj 2023

Primær færdiggørelse (Forventet)

14. maj 2025

Studieafslutning (Forventet)

14. maj 2025

Datoer for studieregistrering

Først indsendt

20. november 2019

Først indsendt, der opfyldte QC-kriterier

20. november 2019

Først opslået (Faktiske)

22. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. september 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 18-2434

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC).

IPD-delingstidsramme

12 to 36 months after initial publication

IPD-delingsadgangskriterier

Access will be given provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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