- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02755012
Impact of Maternal Stress on Infant Stunting
Reducing Maternal Stress Due to Infection, Malnutrition and Psychosocial Conditions of Poverty: A New Paradigm for Tackling Infant Stunting
Descripción general del estudio
Estado
Descripción detallada
Grounded in participatory action research and a socio-ecological framework, this mixed-methods, observational study enrolled a longitudinal cohort of 155 women, seen during pregnancy (6-9 mo), early (0-6 wks) and later (4-6 mo) postpartum, and two cross-sectional cohorts (60 early, 56 later postpartum).
Maternal and infant anthropometry was recorded, maternal fecal, urine and saliva samples were collected, and questionnaires were used to explore household factors (socioeconomic status, food security), social factors (autonomy, paternal/social support, domestic violence), and maternal-level factors (nutrition, infection, emotional distress).
Analyses focused on (1) characterizing women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, (2) describing the maternal diurnal salivary cortisol rhythm in pregnancy and postpartum and explore its association with psychosocial variables, (3) assessing the cumulative impact of maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy, social support, domestic violence), and household factors (socioeconomic status, food security) on early infant growth, and (4) evaluating whether maternal cortisol may be a mediator in the vertical transmission of stress.
In addition, Photovoice activities involved giving a camera to 23 women from study communities, who documented sources of stress vs. resilience for local women, and shared photo-elicited narratives through six group sessions.
Tipo de estudio
Inscripción (Actual)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Woman from study communities
- Either pregnant or 0-6 wk postpartum or 4-6 mo postpartum
- Consenting to participate
Exclusion Criteria:
- Twin pregnancy
- Not consenting to participate
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Longitudinal
155 women enrolled in 2nd or 3rd trimester of pregnancy, and seen again, with their infant, at 0-6 wk postpartum, and 4-6 mo postpartum
|
Early Postpartum
60 women enrolled at 0-6 wk postpartum and seen once with their infant (cross-sectional)
|
Later Postpartum
56 women enrolled at 0-6 wk postpartum and seen once with their infant (cross-sectional)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Infant stunting (Infant height-for-age score)
Periodo de tiempo: 0-6 wk
|
Infant height-for-age score measured at 0-6 wk
|
0-6 wk
|
Infant stunting (Infant height-for-age score)
Periodo de tiempo: 4-6 mo postpartum
|
Infant height-for-age score measured at 4-6 mo postpartum
|
4-6 mo postpartum
|
Change in infant HAZ per month
Periodo de tiempo: Change over time (between 0-6wk and 4-6mo)
|
Change in infant HAZ score between 1st (0-6 wk) and 2nd (4-6 mo) visits
|
Change over time (between 0-6wk and 4-6mo)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anne Marie Chomat, MD, PhD, MPH, McGill University
Publicaciones y enlaces útiles
Publicaciones Generales
- Chomat AM, Solomons NW, Koski KG, Wren HM, Vossenaar M, Scott ME. Quantitative Methodologies Reveal a Diversity of Nutrition, Infection/Illness, and Psychosocial Stressors During Pregnancy and Lactation in Rural Mam-Mayan Mother-Infant Dyads From the Western Highlands of Guatemala. Food Nutr Bull. 2015 Dec;36(4):415-40. doi: 10.1177/0379572115610944. Epub 2015 Oct 19.
- Solomons NW, Vossenaar M, Chomat AM, Doak CM, Koski KG, Scott ME. Stunting at birth: recognition of early-life linear growth failure in the western highlands of Guatemala. Public Health Nutr. 2015 Jul;18(10):1737-45. doi: 10.1017/S136898001400264X.
- Wren HM, Solomons NW, Chomat AM, Scott ME, Koski KG. Cultural determinants of optimal breastfeeding practices among indigenous Mam-Mayan women in the Western Highlands of Guatemala. J Hum Lact. 2015 Feb;31(1):172-84. doi: 10.1177/0890334414560194.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A04-B01-12A
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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