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Monitored Home Exercise in Pregnancy

16 settembre 2020 aggiornato da: Johns Hopkins University

A Randomized Controlled Trial of the Feasibility and Adherence of a Prescribed, Monitored Home Exercise Program in High Risk Pregnant Women

The Study Investigators intend to study the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

Panoramica dello studio

Descrizione dettagliata

The obesity epidemic has affected the reproductive age population with a resultant increase in Gestational Diabetes Mellitus (GDM). Two to 10% of pregnant women are now diagnosed with gestational diabetes, imposing significant increased risk of maternal and fetal/neonatal morbidity and mortality.

Diabetes and obesity can both be combated by participating in daily physical activity, and has been shown to be beneficial for women of all ages, including women that are pregnant. The health benefits of exercise in pregnancy have been extensively studied, demonstrating improved pregnancy outcomes [both maternal (decreased gestational weight gain, decreased rates of cesarean section, and reduced rates of pregnancy induced complications such as hypertension and pre-eclampsia) and neonatal (reduction in proportion of large for gestational age infants)] with no evidence of harm when not contraindicated. Research should now focus on determining the most feasible, constructive, and efficient methods to improve fitness in pregnant women.

Pregnancy provides an ideal opportunity to focus on physical health and fitness; however, physical activity recommendations are rarely met and physical activity consistently decreases in pregnancy. With the development of mobile, technology-based interventions, at-home fitness regimens are now more accessible, thus reducing logistical constraints and burdens posed by traditional physical activity interventions. Moreover, the sustainability of at-home fitness regimens may be more successful long-term/post-intervention due to ease of engagement and more personalized motivational tools. Finally, wearable technology provides real-time feedback of progress and compliance to the intervention team, allowing improved monitoring of goals and compliance. In this way, contemporaneous, mobile health technology can maximize patient care by providing a novel, efficient, low burden, and scalable method to pursue pregnancy fitness, the economic implications of which could be significant.

The objective of this study is to determine the adherence to and effect of a prescribed, monitored at-home exercise regimen in a pregnant population at risk for gestational diabetes, with a specific goal of understanding factors relating to adoption and performance of regular, sustained physical activity.

There will be two arms of the study: an intervention group that will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription, and a comparison group who will receive standard obstetric care, which will include counseling about diet and exercise utilizing American Congress of Obstetricians and Gynecologists (ACOG) guidelines and literature, as well as a FitBit heart rate + activity monitor to track activity levels via step count. The project team will not interact with the comparison group regarding the patient's activity levels during the study duration.

A sample size of 25 women for each arm of the study (50 women total) will be recruited. Basic demographic data will be obtained for all enrolled subjects, including age, parity, pre-pregnancy BMI, family history of diabetes, history of GDM (and number of previously affected pregnancies), preterm birth history, and baseline activity level (type of job, exercise, hours of standing). All participants will be asked to fill out a physical activity in pregnancy readiness survey as well as a baseline, previously validated international physical activity questionnaire, which will be utilized for comparison to activity level data collected during the study period. All enrolled patients will receive a FitBit heart rate + activity monitor, which will provide overall activity data in the form of steps per day through the duration of the trial. Those randomized to the intervention group will also utilize the FitBit during exercise sessions to provide data on duration, heart rate, and intensity, all of which will confirm that exercise is being accomplished as prescribed. This immediate exercise compliance feedback will enable automated motivational factors to engage the patient and optimize their continued exercise participation. Data regarding mode of delivery as well as infant details will be collected by chart review by the research team. Long term follow up may be obtained via email surveys, thus patient emails will be obtained at the time of enrollment.

Tipo di studio

Interventistico

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.

Luoghi di studio

    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21205
        • Johns Hopkins Hospital

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • 18 years of age or greater
  • Singleton gestation
  • History of gestational diabetes
  • OR
  • BMI ≥30
  • OR
  • Significant family history of diabetes (two or more first degree relatives with DM)

Exclusion Criteria:

  • Non-English or non-Spanish speaking patients
  • Women unwilling to provide consent
  • Patients with current diagnosis of diabetes
  • Multiple gestation
  • Medical or pregnancy complications and/or comorbidities that preclude exercise in pregnancy
  • Unwillingness to commit to the prescribed exercise program

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Physical Activity Intervention
Patients will be allocated to a physical activity intervention to be performed 3-5 days per week
Patients will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription
Nessun intervento: Control
Patients will receive standard counseling regarding activity recommendations in pregnancy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence rate
Lasso di tempo: 20 weeks
Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)
20 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gestational Diabetes
Lasso di tempo: 20 weeks
Development of Gestational diabetes as determined by routine 1 hour and then subsequent 3 hour glucose testing results
20 weeks
Maternal Weight Gain
Lasso di tempo: 20 weeks
measured in kilograms
20 weeks
Gestational age at delivery
Lasso di tempo: One year
Infant's gestational age at delivery
One year
Rate of Cesarean delivery
Lasso di tempo: One year
measured as the number of cesarean deliveries per total number of deliveries
One year
Infant weight
Lasso di tempo: One year
Infant weight in grams measured post delivery
One year
Neonatal Apgar scores
Lasso di tempo: 1, 5, and 10 minutes of neonatal life
An assessment of neonatal wellbeing measured at 1, 5, and 10 minutes post-delivery, and is measured on a scale of 0-9, with 9 being the highest, and 0 being the lowest.
1, 5, and 10 minutes of neonatal life
Neonatal Intensive Care Unit (NICU) Admission Rate
Lasso di tempo: One year
Rate of admission of infants post-delivery to the NICU
One year
Neonatal hypoglycemia rates
Lasso di tempo: One year
Number of infants with hypoglycemia divided by the total number of delivered infants
One year

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Jeanne Sheffield, MD, Johns Hopkins University

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 (Effettivo)

1 novembre 2018

Completamento primario (Effettivo)

8 ottobre 2019

Completamento dello studio (Effettivo)

8 ottobre 2019

Date di iscrizione allo studio

Primo inviato

3 maggio 2018

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2018

Primo Inserito (Effettivo)

11 giugno 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2020

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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 .

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