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Health Coach Intervention Pilot Study (AHA)

14 de marzo de 2017 actualizado por: Harvard Pilgrim Health Care

Supporting Healthful Lifestyles During Pregnancy: A Health Coach Intervention Pilot Study

In this mixed methods study, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women. At one northeastern US clinic, the investigators enrolled 30 overweight (pre-pregnancy BMI≥25 kg/m2) pregnant women at a median gestation of 12.5 weeks (IQR: 11-15) into a one arm intervention trial. The investigators connected participants with a health coach to provide behavioral support to help participants adopt or maintain healthy lifestyle goals during pregnancy. Health coaches contacted participants by phone every 2-3 weeks to monitor goals, and sent emails and text messages to check-in between calls. To assess the intervention, participants completed baseline (N=30) and follow-up surveys at the end of the intervention (N=26), as well as follow-up phone interviews (N=18).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

<Health Coach Intervention > The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation. During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track. Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.

During the first call, health coaches invited participants to prioritize these goals according to their level of self-efficacy, readiness to change, preferences, and values. Throughout the intervention, health coaches used principles of motivational interviewing that relied on a patient-centered approach to enhance readiness to change by exploring ambivalence and resistance to change. In addition to setting personal goals, health coaches also presented optimal goals for ideal cardiovascular health.

During follow-up calls, health coaches monitored progress and helped adjust goals when necessary (e.g. too many goals, or the goal was too ambitious). Health coaches also addressed barriers and potential solutions with participants, and helped them target higher goal settings or select novel goals when participants attained them. Health coaches sent emails or text messages depending on participant preferences to check-in about progress toward goals or clinical appointments between calls. Research staff (including an MD) met weekly with health coaches to review their conversations with participants, and to address any medical issues to ensure that it would be reported to the primary care provider obstetric team if appropriate.

<Study Design and Sample> Participants completed baseline (N=30) and follow-up (N=26) surveys at the end of the intervention as well as follow-up phone interviews (N=18). Surveys collected information on demographics, attitudes related to weight status and pregnancy, opinions about the intervention, and included food frequency questions . Interviews followed a guide of open-ended questions to determine insights on what helped achieve goals, motivation, opinions of the health coach intervention, and areas for improvement. One study staff member, who has experience with qualitative data collection, conducted all of the individual interviews. This study was approved by the Harvard Pilgrim Health Care Human Studies Committee.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

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

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Harvard Pilgrim Health Care Institute

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:

  • pregnant (less than 16 weeks of gestation),
  • overweight or obese (pre-pregnancy BMI≥25 kg/m2),
  • 18 years of age or older,
  • English speaking,
  • planned to remain at the same obstetrics clinic for the duration of their pregnancies.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Health Coach Intervention
The investigators connected participants at enrollment (median gestation of 12.5 weeks, IQR: 11-15) with a trained health coach who called participants every 2-3 weeks until 36 weeks of gestation. During these phone calls, health coaches helped participants adopt and maintain new healthful lifestyle behaviors that were evidence-based, simple, and easy to track. Goals aimed to promote appropriate gestational weight gain and covered several domains including diet, physical activity, screen time, and sleep.
Please see arm description.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Satisfaction with the health coach intervention as assessed by surveys
Periodo de tiempo: From enrollment until the end of the intervention at 36 weeks of gestation.
The investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women using baseline and follow-up surveys.
From enrollment until the end of the intervention at 36 weeks of gestation.
Satisfaction with the health coach intervention as assessed by phone interviews
Periodo de tiempo: From enrollment until the end of the intervention at 36 weeks of gestation.
Using an interview guide, the investigators assessed the feasibility and acceptability of a remote health coach intervention to promote healthful lifestyle behaviors among overweight pregnant women.
From enrollment until the end of the intervention at 36 weeks of gestation.

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Marie-France Hivert, MD, MMSc, Harvard Pilgrim Health Care Institute

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.

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)

16 de julio de 2015

Finalización primaria (Actual)

27 de junio de 2016

Finalización del estudio (Actual)

27 de junio de 2016

Fechas de registro del estudio

Enviado por primera vez

22 de febrero de 2017

Primero enviado que cumplió con los criterios de control de calidad

14 de marzo de 2017

Publicado por primera vez (Actual)

15 de marzo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de marzo de 2017

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

14 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PH000523C
  • 14CRP20490354 (Otro número de subvención/financiamiento: American Heart Association)

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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