- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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
|
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infant stunting (Infant height-for-age score)
Time Frame: 0-6 wk
|
Infant height-for-age score measured at 0-6 wk
|
0-6 wk
|
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Infant stunting (Infant height-for-age score)
Time Frame: 4-6 mo postpartum
|
Infant height-for-age score measured at 4-6 mo postpartum
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4-6 mo postpartum
|
|
Change in infant HAZ per month
Time Frame: Change over time (between 0-6wk and 4-6mo)
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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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Marie Chomat, MD, PhD, MPH, McGill University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A04-B01-12A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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