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Completed

NCT Number: NCT02979418

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

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.

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Key information

Conditions

Maternal and Child Health HIV

Age range

18 year–48 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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)

    Time frame: 2 years

    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).

  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)

    Time frame: 2 years

    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).

  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)

    Time frame: 2 years

    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).

  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)

    Time frame: 2 years

    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).

Secondary outcomes

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

    Time frame: 2 years

    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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Kenya Medical Research Institute

Registry information

Acronym: PEN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2016
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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