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Monitored Home Exercise in Pregnancy

16 de septiembre de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21205
        • Johns Hopkins Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Sin intervención: Control
Patients will receive standard counseling regarding activity recommendations in pregnancy

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence rate
Periodo de tiempo: 20 weeks
Total number of performed exercise sessions divided by prescribed exercise sessions (3 per week at minimum)
20 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gestational Diabetes
Periodo de tiempo: 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
Periodo de tiempo: 20 weeks
measured in kilograms
20 weeks
Gestational age at delivery
Periodo de tiempo: One year
Infant's gestational age at delivery
One year
Rate of Cesarean delivery
Periodo de tiempo: One year
measured as the number of cesarean deliveries per total number of deliveries
One year
Infant weight
Periodo de tiempo: One year
Infant weight in grams measured post delivery
One year
Neonatal Apgar scores
Periodo de tiempo: 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
Periodo de tiempo: One year
Rate of admission of infants post-delivery to the NICU
One year
Neonatal hypoglycemia rates
Periodo de tiempo: One year
Number of infants with hypoglycemia divided by the total number of delivered infants
One year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Jeanne Sheffield, MD, Johns Hopkins University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2018

Finalización primaria (Actual)

8 de octubre de 2019

Finalización del estudio (Actual)

8 de octubre de 2019

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

7 de junio de 2018

Publicado por primera vez (Actual)

11 de junio de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

16 de septiembre de 2020

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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