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Maternal and Child HealthPENNCT02979418

Pii Ngima: Consequences of Water Insecurity for Maternal and Child Health

An observational study of Maternal and Child Health and HIV, run by Northwestern University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will implement the validated household-level water insecurity scale developed by study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a range of outcomes linked to water insecurity, such as viral load, hydration status, maternal depression, stress, food insecurity, and… Read more about this study

Who is it for?
Ages 18 to 48 years, women onlyHealthy volunteers can take part
Conditions the study is for
Maternal and Child Health, HIV
How many people
266 participants
Where
No sites listed yet
Study dates
Feb 2016to 31 Jul 2017
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 18 to 48 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: A cohort of postpartum HIV-infected and -uninfected women (ratio 1:1) who were previously enrolled into the Pith Moromo (clinical trials ID: NCT02974972) research study in Nyanza, Kenya.

Who may be able to join

  • Women >18 years of age with infants enrolled into the Pith Moromo (clinical trials ID: NCT02974972) study
  • Infants born to pregnant women enrolled in the cohort study

Who cannot join

  • Individuals <18 years of age that are not infants born to women enrolled in the cohort study

About this study

This study will implement the validated household-level water insecurity scale developed by study investigators among a cohort of postpartum women in Nyanza, Kenya and will assess a range of outcomes linked to water insecurity, such as viral load, hydration status, maternal depression, stress, food insecurity, and cognitive development.

Read the detailed description

This study will develop the first well-known household water insecurity scale. Currently, water insecurity cannot be measured at the level of the household or individual, i.e. at the endpoint of water use. Although there are myriad national, regional, community, and hydrological indexes of water availability, to the investigators' knowledge, there is no way of measuring water access at the household or individual levels. Without a comprehensive, validated scale to measure household water insecurity, the scientific, programmatic, and public health communities cannot empirically test the prevalence of household water insecurity access and its potential impacts on economic, nutrition, disease, and psychosocial health pathways and outcomes.

Keywords
Water insecurity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine if water insecurity (novel scale) is detrimental to physical health (hemoglobin, hair cortisol, other biomarkers) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)

    The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).

    Measured: 2 years

  2. Determine if water insecurity (novel scale) is detrimental to nutrition (Household Dietary Diversity Scale) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)

    The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).

    Measured: 2 years

  3. Determine if water insecurity (novel scale) is detrimental to psychosocial health (Perceived Stress Scale, Center for Epidemiology Depression (CES-D) scale, etc.), in ways distinct from food insecurity (Individual Food Insecurity Access Scale)

    The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).

    Measured: 2 years

  4. Determine if water insecurity (novel scale) is detrimental to economic security (asset index) in ways distinct from food insecurity (Individual Food Insecurity Access Scale)

    The investigators are collecting longitudinal cohort data from women who were recruited during pregnancy and have been followed through the first 18 months of the infant's life. Participants are interviewed at regular intervals to gather information on the various pathways through which water insecurity (measured using a novel scale) may be deleterious in ways similar to food insecurity (measured using the Individual Food Insecurity Access Scale).

    Measured: 2 years

Secondary outcomes (1)

  1. Determining if water insecurity (measured using a novel tool) will differ by HIV status

    The investigators collected longitudinal data to assess water insecurity among the cohort (using a novel tool) and will compare the prevalences and impacts of water insecurity by HIV status

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion31 Jul 2017
  4. Study completion31 Jul 2017

Resources

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
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02979418
Sponsor's protocol ID
STU00203155
Acronym
PEN
Status last verified
Nov 2020
First submitted
28 Nov 2016
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Krumdieck NR, Collins SM, Wekesa P, Mbullo P, Boateng GO, Onono M, Young SL. Household water insecurity is associated with a range of negative consequences among pregnant Kenyan women of mixed HIV status. J Water Health. 2016 Dec;14(6):1028-1031. doi: 10.2166/wh.2016.079.

    PubMed 27959881

  • Brooks YM, Collins SM, Mbullo P, Boateng GO, Young SL, Richardson RE. Evaluating Human Sensory Perceptions and the Compartment Bag Test Assays as Proxies for the Presence and Concentration of Escherichia coli in Drinking Water in Western Kenya. Am J Trop Med Hyg. 2017 Oct;97(4):1005-1008. doi: 10.4269/ajtmh.16-0878. Epub 2017 Jul 27.

    PubMed 28749760

  • Miller JD, Fitzgerald KG, Smith AL, Young SL. Geophagy among a Cohort of Kenyan Women with Mixed HIV Status: A Longitudinal Analysis. Am J Trop Med Hyg. 2019 Sep;101(3):654-660. doi: 10.4269/ajtmh.19-0149.

    PubMed 31333167

  • Boateng GO, Workman CL, Miller JD, Onono M, Neilands TB, Young SL. The syndemic effects of food insecurity, water insecurity, and HIV on depressive symptomatology among Kenyan women. Soc Sci Med. 2022 Feb;295:113043. doi: 10.1016/j.socscimed.2020.113043. Epub 2020 May 15.

    PubMed 32482382

  • Collins SM, Mbullo Owuor P, Miller JD, Boateng GO, Wekesa P, Onono M, Young SL. 'I know how stressful it is to lack water!' Exploring the lived experiences of household water insecurity among pregnant and postpartum women in western Kenya. Glob Public Health. 2019 May;14(5):649-662. doi: 10.1080/17441692.2018.1521861. Epub 2018 Sep 20.

    PubMed 30231793

  • Alvarez GG, Miller JD, Santoso MV, Wekesa P, Owuor PM, Onono M, Young SL. Prevalence and Covariates of Food Insecurity Across the First 1000 Days Among Women of Mixed HIV Status in Western Kenya: A Longitudinal Perspective. Food Nutr Bull. 2021 Sep;42(3):319-333. doi: 10.1177/0379572121999024. Epub 2021 May 20.

    PubMed 34011176

  • Benzaken CL, Miller JD, Onono M, Young SL. Development of a cumulative metric of vaccination adherence behavior and its application among a cohort of 12-month-olds in western Kenya. Vaccine. 2020 Apr 16;38(18):3429-3435. doi: 10.1016/j.vaccine.2020.03.011. Epub 2020 Mar 14.

    PubMed 32184035

Questions about this trial

What is this clinical trial studying?

An observational study of Maternal and Child Health and HIV, run by Northwestern 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 2 inclusion and 1 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 13 Nov 2020. 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?

Determine if water insecurity (novel scale) is detrimental to physical health (hemoglobin, hair cortisol, other biomarkers) in ways distinct from food insecurity (Individual Food Insecurity Access Scale) (time frame: 2 years). The study lists 4 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 NCT02979418, which also lists 7 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 13 Nov 2020.

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