NCT02755012

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

April 19, 2016

Last Update Submit

April 26, 2016

Conditions

Maternal; MalnutritionInfant MalnutritionPhysiological StressEmotional StressLife StressDomestic ViolenceInfectionBreast FeedingMastitis

Keywords

Maternal HealthGuatemalaIndigenous PopulationStuntingFood InsecurityPovertySocial SupportMaternal AutonomyPaternal SupportCortisol Rhythm

Outcome Measures

Primary Outcomes (3)

  • Infant stunting (Infant height-for-age score)

    Infant height-for-age score measured at 0-6 wk

    0-6 wk

  • Infant stunting (Infant height-for-age score)

    Infant height-for-age score measured at 4-6 mo postpartum

    4-6 mo postpartum

  • 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)

Study Arms (3)

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)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Indigenous Mam-Mayan women living in 8 rural hamlets (or communities) in the municipality of San Juan Ostuncalco, in the department of Quetzaltenango, Guatemala.

You may qualify if:

  • Woman from study communities
  • Either pregnant or 0-6 wk postpartum or 4-6 mo postpartum
  • Consenting to participate

You may not qualify if:

  • Twin pregnancy
  • Not consenting to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 Western Highlands of Guatemala. Food Nutr Bull. 2015 Dec;36(4):415-40. doi: 10.1177/0379572115610944. Epub 2015 Oct 19.

    PMID: 26481796RESULT

  • 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.

    PMID: 26017476RESULT

  • 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.

    PMID: 25583316RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool sample (mother and infant) Urine sample (mother) Saliva sample (mother) Breast milk sample (mother)

MeSH Terms

Conditions

MalnutritionInfant Nutrition DisordersStress, PsychologicalInfectionsBreast FeedingMastitisGrowth Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavioral SymptomsBehaviorFeeding BehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anne Marie Chomat, MD, PhD, MPH

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 28, 2016

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 28, 2016

Record last verified: 2016-04