- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04499404
A WeChat-based Intervention to Support Breastfeeding
A WeChat-based Intervention to Promote and Support Breastfeeding in China: A Multi-center Randomized Controlled Trial
The aim of the randomized controlled trial (RCT) is to evaluate the effects of an intervention program delivered via WeChat platform to support exclusive breastfeeding in China. WeChat, a free smart phone application, is the most popular social networking platform in China. It will be used to deliver health educational messages to the study participants. Our hypothesis is that the intervention program can lead to at least a 10% increase in exclusive breastfeeding prevalence at 6 months when compared to the control group.
A multicenter RCT of 1,000 participants will be conducted at four maternity hospitals in Chengdu, China. Eligible pregnant women who consent to participate will be recruited from the antenatal clinic at around 30 weeks of gestation and will be randomly assigned to either the intervention or control group on a 1:1 ratio.
After randomization, all participants will be asked to scan a Quick Response code to follow our WeChat public account, which can send push notifications to alert participants for new content, topics, links to a searchable library and frequently asked questions and answers. From baseline until childbirth, control group participants will receive non-breastfeeding related messages, such as healthy lifestyle and nutrition during pregnancy, from WeChat, whereas the intervention group participants will receive breastfeeding related messages, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from WeChat. After childbirth, intervention group mothers will continue to receive information about breastfeeding for 6 months. The investigators will use WeChat to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding. Meanwhile, the control group participants will receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc.
Each participant will be interviewed in person by trained nurses at baseline, at discharge and be interviewed by telephone using structured questionnaires at 1, 4, and 6 months postpartum to collect detailed information on breastfeeding practices. All participants receive normal prenatal and postpartum maternity services. Cox proportional hazard models and multilevel mixed regression models will be performed respectively to compare the duration of exclusive breastfeeding and the rates of exclusive breastfeeding within six months postpartum between intervention and control groups.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Li Tang, PhD
- Número de teléfono: +86 15002872018
- Correo electrónico: tangli207@hotmail.com
Ubicaciones de estudio
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Chengdu, Porcelana
- Reclutamiento
- Chengdu Qingyang Maternal and Child Health Hospital
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Contacto:
- Xu Yan
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- own a smart phone;
- 18 years or above;
- sufficient language skills (completed secondary school education);
- carry a singleton fetus;
- at a gestational age of 28 to 30 weeks;
Exclusion Criteria:
- have existing medical conditions or pregnancy complications which may inhibit breastfeeding initiation, according to their medical doctor;
- intend to give birth in health institutes other than the study hospitals.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
Participants receive breastfeeding-related information from WeChat
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Participants in the intervention group will be asked to follow our WeChat public account immoderately after randomization.
They will receive breastfeeding related messages three times a week from WeChat, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from baseline until childbirth.
After childbirth, intervention group mothers will continue to receive information, which is mainly about breastfeeding, once a week for 6 months.
WeChat will send push notifications to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding.
|
Comparador activo: Control group
Participants receive non-breastfeeding information from WeChat
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Participants in the control group will be asked to follow our WeChat public account immoderately after randomization.
They will receive messages mainly on topics of healthy lifestyle and nutrition during pregnancy, from baseline until childbirth.
After childbirth, they will continue to receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc., until 6 months postpartum.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Exclusive breastfeeding rate at 6 months postpartum
Periodo de tiempo: 6 months postpartum
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Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
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6 months postpartum
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Full breastfeeding rate at 6 months postpartum
Periodo de tiempo: 6 months postpartum
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Infants who are receiving almost all of their nutrients from breast milk but take some other liquids such as water, water-based drinks, oral rehydration solutions, ritual fluids, and drops or syrups.
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6 months postpartum
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Infant's first feed
Periodo de tiempo: 0-7 days postpartum
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% of infants fed with breastmilk as their first feed
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0-7 days postpartum
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Exclusive breastfeeding duration to 4 months postpartum
Periodo de tiempo: 0-4 months postpartum
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Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
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0-4 months postpartum
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Exclusive breastfeeding duration to 6 months postpartum
Periodo de tiempo: 0-6 months postpartum
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Breastfeeding while giving no other food or liquid, not even water, with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines.
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0-6 months postpartum
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Rate of early introduction of complementary feeding
Periodo de tiempo: 0-4 months postpartum
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Complementary feeding is defined as feeding infants with solid foods and liquids other than breastmilk or infant formula.
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0-4 months postpartum
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Any breastfeeding duration to 6 months postpartum
Periodo de tiempo: 0-6 months postpartum
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The child has received breastmilk (direct from the breast or expressed) with or without other drink, formula or other infant food
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0-6 months postpartum
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2019FYH014
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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