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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02755012
Other study ID # A04-B01-12A
Secondary ID
Status Completed
Phase N/A
First received April 19, 2016
Last updated April 26, 2016
Start date June 2012
Est. completion date November 2013

Study information

Verified date April 2016
Source McGill University
Contact n/a
Is FDA regulated No
Health authority Canada: Institutional Review BoardGuatemala: Comité de Estudios en Humanos
Study type Observational

Clinical Trial Summary

This study takes place in rural Mam-Mayan communities of Guatemala characterized by high rates of childhood stunting. It aims to characterize women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, to evaluate 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 to evaluate whether maternal cortisol may be a mediator in the vertical transmission of stress.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 271
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
McGill University Center for Studies of Sensory Impairment, Aging and Metabolism

References & Publications (3)

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 West — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Infant stunting (Infant height-for-age score) Infant height-for-age score measured at 0-6 wk 0-6 wk No
Primary Infant stunting (Infant height-for-age score) Infant height-for-age score measured at 4-6 mo postpartum 4-6 mo postpartum No
Primary Change in infant HAZ per month 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) No
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