Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Sleep and Tracking Effects in Pregnancy Study (STEP)

12 settembre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

250

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • University of North Carolina
        • Contatto:
          • Tracy Manuck, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 51 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Usual care
Women randomized to this group will receive no guidance regarding exercise / activity / sleep during pregnancy.
Sperimentale: Activity Intervention
Women randomized to this group will receive detailed information and reminders about physical activity and sleep in pregnancy. .
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction in Perceived Maternal Stress
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of activity goals met by personalized activity level group
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of North Carolina, Chapel Hill

Investigatori

  • Investigatore principale: Tracy A Manuck, MD, University of North Carolina, Chapel Hill

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 maggio 2023

Completamento primario (Anticipato)

14 maggio 2025

Completamento dello studio (Anticipato)

14 maggio 2025

Date di iscrizione allo studio

Primo inviato

20 novembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

20 novembre 2019

Primo Inserito (Effettivo)

22 novembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 settembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2022

Ultimo verificato

1 luglio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18-2434

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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).

Periodo di condivisione IPD

12 to 36 months after initial publication

Criteri di accesso alla condivisione 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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Activity Intervention

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Tanzania

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi