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Teaching Appropriate Gestational Weight Gain (TAGG)

13 de agosto de 2019 actualizado por: Geisinger Clinic
The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.

The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.

Tipo de estudio

Intervencionista

Inscripción (Actual)

218

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

  • Estados Unidos
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Geisinger Health System

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
  • Less than 16 weeks gestation
  • Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
  • Singleton gestation
  • Access to a phone

Exclusion Criteria:

  • BMI less than 30 kg/m2
  • Gestational age greater than or equal to 16 weeks
  • Active diagnosis of cancer on their electronic health record problem list
  • Acquired immunodeficiency syndrome (AIDS)
  • Palliative medicine patients
  • Multiple gestations
  • GWG in excess of 11 pounds prior to study enrollment
  • Patients with Non-Geisinger prenatal care providers
  • Vegan diet
  • Malabsorptive conditions
  • Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
  • Non-English Speaking

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Standard of Care (SOC)
Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.
Experimental: Enhanced Care (EC)

In addition to standard of care, the study participants will also receive:

i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.
Conductual: Enhanced Care

In addition to standard of care, the study participants will also receive:

i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.

Otros nombres:
  • CE

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Gestational weight gain, adjusting for time in the study
Periodo de tiempo: at delivery
at delivery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient knowledge and expectations factors
Periodo de tiempo: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Attitude on pregnancy weight gain
Periodo de tiempo: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Self-efficacy of healthy eating
Periodo de tiempo: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Eating, sleeping and physical activity behavior
Periodo de tiempo: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Patient-experience and involvement in care
Periodo de tiempo: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Delivery of large for gestational age infants
Periodo de tiempo: At Delivery
This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.
At Delivery
Diagnosis of gestational diabetes mellitus
Periodo de tiempo: Baseline through 4-12 Weeks Postpartum
This measure will be obtained using EHR data and analyzed utilizing clinic data points.
Baseline through 4-12 Weeks Postpartum
Neonatal intensive care unit (NICU) admissions
Periodo de tiempo: At Delivery
At Delivery
Cost of Treatment
Periodo de tiempo: Baseline through 4-12 Weeks Postpartum
Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.
Baseline through 4-12 Weeks Postpartum
Mode of delivery
Periodo de tiempo: At Delivery
Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.
At Delivery
Rate of gestational weight gain
Periodo de tiempo: Baseline through 4-12 weeks postpartum
Baseline through 4-12 weeks postpartum
Perceived stress measured via Perceived Stress Scale
Periodo de tiempo: Baseline through 4-12 weeks postpartum
Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al.
Baseline through 4-12 weeks postpartum
Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Periodo de tiempo: Baseline through 4-12 Weeks postpartum
Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.
Baseline through 4-12 Weeks postpartum

Colaboradores e Investigadores

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

Patrocinador

Geisinger Clinic

Colaboradores

Penn State University

Investigadores

  • Investigador principal: Awathif D Mackeen, MD, MPH, Geisinger Clinic

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

1 de noviembre de 2016

Finalización primaria (Actual)

1 de julio de 2018

Finalización del estudio (Actual)

1 de julio de 2019

Fechas de registro del estudio

Enviado por primera vez

12 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

10 de noviembre de 2016

Publicado por primera vez (Estimar)

15 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2019

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

13 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2016-0205

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

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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