Maternal; MalnutritionNCT02755012
Impact of Maternal Stress on Infant Stunting
An observational study of Maternal; Malnutrition and Infant Malnutrition, run by McGill University.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal; Malnutrition, Infant Malnutrition, Physiological Stress
- How many people
- 271 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Woman from study communities
- Either pregnant or 0-6 wk postpartum or 4-6 mo postpartum
- Consenting to participate
Who cannot join
- Twin pregnancy
- Not consenting to participate
About this study
Official title: Reducing Maternal Stress Due to Infection, Malnutrition and Psychosocial Conditions of Poverty: A New Paradigm for Tackling Infant Stunting
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.
Read the 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.
- Conditions
- Maternal; Malnutrition, Infant Malnutrition, Physiological Stress, Emotional Stress, Life Stress, Domestic Violence
- Keywords
- Maternal Health, Guatemala, Indigenous Population, Stunting, Food Insecurity, Poverty, Social Support, Maternal Autonomy, Paternal Support, Cortisol Rhythm
- Medical subject headings
- Malnutrition, Infant Nutrition Disorders, Stress, Psychological, Infections, Breast Feeding, Mastitis, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant stunting (Infant height-for-age score)
Infant height-for-age score measured at 0-6 wk
Measured: 0-6 wk
Infant stunting (Infant height-for-age score)
Infant height-for-age score measured at 4-6 mo postpartum
Measured: 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
Measured: Change over time (between 0-6wk and 4-6mo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startJun 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Maternal; MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Studies of Sensory Impairment, Aging and Metabolism
- Responsible party
- Principal investigator, Anne Marie Chomat, McGill University
- Investigators
- Anne Marie Chomat, MD, PhD, MPH, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755012
- Sponsor's protocol ID
- A04-B01-12A
- Status last verified
- Apr 2016
- First submitted
- 19 Apr 2016
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 26481796Solomons 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.
PubMed 26017476Wren 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.
PubMed 25583316Lopez Leyva L, Gonzalez E, Maurice CF, Koski KG. Distinct associations among human milk microbiota and minerals in relation to early infant growth: a longitudinal study. J Transl Med. 2026 May 28. doi: 10.1186/s12967-026-08315-7. Online ahead of print.
PubMed 42210393
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Maternal Stress Due to Infection, Malnutrition and Psychosocial Conditions of Poverty: A New Paradigm for Tackling Infant Stunting
- ClinicalTrials.gov ID
- NCT02755012
- Acronym / sponsor ID
- A04-B01-12A
- Conditions
- Maternal; Malnutrition, Infant Malnutrition, Physiological Stress, Emotional Stress, Life Stress, Domestic Violence
- Keywords
- Maternal Health, Guatemala, Indigenous Population, Stunting, Food Insecurity, Poverty, Social Support, Maternal Autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Center for Studies of Sensory Impairment, Aging and Metabolism
- Study start
- Jun 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Woman from study communities
- Either pregnant or 0-6 wk postpartum or 4-6 mo postpartum
- Consenting to participate
Key exclusion criteria (2 listed)
- Twin pregnancy
- Not consenting to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infant stunting (Infant height-for-age score)
Time frame: 0-6 wk
Infant height-for-age score measured at 0-6 wk
Infant stunting (Infant height-for-age score)
Time frame: 4-6 mo postpartum
Infant height-for-age score measured at 4-6 mo postpartum
Change in infant HAZ per month
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Results publication: PubMed 26481796Chomat 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.
- Results publication: PubMed 26017476Solomons 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.
- Results publication: PubMed 25583316Wren 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.
- Derived from this study: PubMed 42210393Lopez Leyva L, Gonzalez E, Maurice CF, Koski KG. Distinct associations among human milk microbiota and minerals in relation to early infant growth: a longitudinal study. J Transl Med. 2026 May 28. doi: 10.1186/s12967-026-08315-7. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Marie Chomat, MD, PhD, MPH principal investigator
McGill University
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal; Malnutrition and Infant Malnutrition, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant stunting (Infant height-for-age score) (time frame: 0-6 wk). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02755012, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.