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Sleep and Tracking Effects in Pregnancy Study (STEP)

12 września 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

250

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • North Carolina
      • Chapel Hill, North Carolina, Stany Zjednoczone, 27599
        • University of North Carolina
        • Kontakt:
          • Tracy Manuck, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 51 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Usual care
Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.
Eksperymentalny: Activity Intervention
Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Reduction in Perceived Maternal Stress
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of activity goals met by personalized activity level group
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of North Carolina, Chapel Hill

Śledczy

  • Główny śledczy: Tracy A Manuck, MD, University of North Carolina, Chapel Hill

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

1 maja 2023

Zakończenie podstawowe (Oczekiwany)

14 maja 2025

Ukończenie studiów (Oczekiwany)

14 maja 2025

Daty rejestracji na studia

Pierwszy przesłany

20 listopada 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 listopada 2019

Pierwszy wysłany (Rzeczywisty)

22 listopada 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 września 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 września 2022

Ostatnia weryfikacja

1 lipca 2022

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 18-2434

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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).

Ramy czasowe udostępniania IPD

12 to 36 months after initial publication

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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