Feeding BehaviorNCT03209999
Maternal Employment in Low and Middle-income Countries and Infant Feeding
An observational study of Feeding Behavior and Maternal Health, run by University of Washington at 1 site in United States.
Trial summary
Using cross-sectional samples from over 40 Demographic and Health Surveys, the investigators studied the association between maternal employment and 3 indicators of Infant and Young Child Feeding (IYCF): exclusive breastfeeding (EBF) among children less than 6 months old (N=39,791) and minimum diet diversity (MDD) and… Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Feeding Behavior, Maternal Health
- How many people
- 39,791 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 1 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 1 month to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Maternal-child dyads within one of 50 low and middle-income countries with a Demographic and Health Survey since 2010
Who may be able to join
- Last born child, ages 1 to < 24 months
- Child living with mother
Who cannot join
- Complete data available for maternal employment, children's dietary diversity, minimum meal frequency data
- Complete covariates available for maternal education, maternal age, marital status, parity, morbidity in the past 2 weeks, child age, and urban/rural status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Employment in Low and Middle-income Countries is Associated With Improved Infant and Young Child Feeding in Children
Using cross-sectional samples from over 40 Demographic and Health Surveys, the investigators studied the association between maternal employment and 3 indicators of Infant and Young Child Feeding (IYCF): exclusive breastfeeding (EBF) among children less than 6 months old (N=39,791) and minimum diet diversity (MDD) and minimum meal frequency (MMF) (N=137,208) among children 6 to 23 months old. Mothers were categorized as formally employed, informally employed, or non-employed. The investigators first used adjusted logistic regression models to assess the associations within each country. The investigators then used meta-analysis to pool associations across all countries and by region.
Read the detailed description
Data Source and Population
The investigators analyzed cross-sectional data from the Demographic and Health Surveys (DHS). DHS surveys employ standardized questionnaires and nationally representative, multi-stage cluster sampling to allow for cross-country comparisons (34).
Our study included DHS datasets that were administered between 2010 and April 2017 and that contained data on women's employment status and indicators of IYCF. Analyses included women who had at least one child between ages 0-24 months. If mothers had more than one child, the investigators included the youngest child in the household. Children residing outside the household were excluded.
In models that evaluated MDD and MMF as the dependent variables, the final analytic sample included 137,208 children aged 6 to 23 months from 50 countries. Small cell sizes were prohibitive to exploring the employment-EBF associations in 10 countries that met the aforementioned inclusion criteria; therefore, when modeling EBF as the dependent variable, the final analytic sample included 39,791 children aged 0 to 5 months in 40 countries.
Primary Dependent Variables
EBF, MDD, and MMF served as the primary dependent variables of interest as prior literature suggests changes in women's income and time, stemming from women's employment, may affect these indicators of IYCF. These indicators were created using data from the 24-hour recall of foods/food groups available in DHS. EBF, a binary variable, was defined as the proportion of infants 0 to 5 months of age who were fed exclusively with breast milk. MDD, a binary variable, was defined as proportion of children 6 to 23 months of age who received foods from 4 or more of the following 7 food groups: grains, roots and tubers; legumes and nuts; dairy products (milk, yogurt, cheese); flesh foods (meat, fish, poultry and liver/organ meats); eggs; vitamin-A rich fruits and vegetables; and other fruits and vegetables. MMF, a binary variable, was defined as the proportion of breastfed and non-breastfed children 6 to 23 months of age who receive solid, semi-solid, or soft foods the minimum number of times or more. For breastfed children, the minimum number of times varies with age (2 times if 6 to 8 months and 3 times if 9 to 23 months). Non-breastfed children ages 6 to 23 months must be fed 4 or more times per day to meet the MMF indicator.
Primary Independent Variable
The investigators modeled maternal employment as a 3-category variable: formally employed, informally employed, and non-employed based on prior research which suggests: 1) a large proportion of women in LMIC are engaged in less formalized employment and 2) wages earned are more than 60% lower in the informal sector. Women are described as non-employed because this term includes persons who choose to not seek employment whereas unemployed describes persons without jobs who are actively seeking employment.
Employment type was defined based on 4 indicators: 1) employment status in the last 12 months (employed, non-employed); 2) aggregate occupation category (skilled, unskilled); 3) type of earnings (cash only, cash and in-kind, in-kind only, unpaid); and 4) seasonality of employment (all year, seasonal/occasional employment). Formal employment included the following 3 combinations: 1) employed, skilled occupation, cash only earnings, employed all year; 2) employed, skilled occupation, cash only earnings, seasonal/occasional employment; and 3) employed, unskilled occupation, cash only earnings, employed all year. Other employed women were categorized as informally employed.
Confounders and Effect Measure Modifiers
The investigators identified confounding factors a priori using a directed acyclic graph, which is a causal diagram used to characterize the relationship among variables that influence the primary independent and the dependent variables based on both theorized and documented relationships. In all models, confounders included maternal education (< primary school complete, [Symbol] primary school complete), maternal age (years), marital status (married or living together versus single, widowed, divorced), parity, morbidity (presence of diarrhea or fever in the last two weeks), child age (months), and urban/rural status. The investigators aimed to specify covariates in a way that allowed for the same specification in each country and for each outcome. For variables that were in their continuous form in the DHS (maternal age, child age, parity), the investigators assessed their linearity with the outcomes by specifying disjoint indicator variables. Because variables were approximately linearly associated with the outcomes in most countries, they were retained in their continuous form to minimize the number of observations dropped from the model due to small cell sizes. Marital status and maternal education were dichotomized because there were very few people in some categories (e.g. divorced).
The investigators hypothesized that the employment-diet association would vary by countries' stage in the nutrition transition. Therefore, the investigators explored differences in the country-level associations by log-gross domestic product (GDP) per capita, adjusted for purchasing power parity, a theorized driver of the nutrition transition (41). Data were obtained from the World Development Indicators database, corresponding to the survey year (42). GDP-per capita was log-transformed to reflect the expected influence of a percent increase (e.g. 5%), rather than an absolute dollar increase (e.g. $5).
Statistical Analysis
Within-country analyses. It is expected that trends in employment (i.e. the percent of women in formal versus informal employment) as well as diet to differ depending on countries' stage of the nutrition transition. Therefore, the investigators aimed to keep samples comparable by selecting countries with a recent DHS (2010-2017) and we allowed for different relationships in each country by starting with disaggregate, country-specific estimates. The investigators first employed separate multivariable logistic regression models for each country to test the association between maternal employment and IYCF indicators (EBF, MDD, MMF). In these country-specific models, the investigators utilized sampling weights to account for differential probability of selection and response and Taylor series linearized standard errors accounted for DHS' clustered design.
Between-country and region analyses. After obtaining disaggregated estimates for each country, coefficients for the employment-EBF, employment-MDD, and employment-MMF associations were entered into a random effects meta-analysis to obtain odds ratios pooled across all countries and by world region (East Asia and Pacific, Europe and Central Asia, Latin American and Caribbean, Middle East and North Africa, South Asia, and sub-Saharan Africa). Random effects meta-analysis, used to generate pooled odds ratios (POR), is the statistical combination of the estimates from separate countries and assumes that the associations between employment and IYCF may differ by country and/or region.
Country-specific beta coefficients were also entered into a random-effects meta-regression to assess whether the associations between employment and IYCF varied by country-level log-GDP.
Sensitivity Analyses. Sensitivity analyses included modeling several alternative outcomes including: 1) continued breastfeeding at 1 year, 2) diet diversity score, and 3) minimum acceptable diet. Continued breastfeeding at 1 year, a binary variable, was defined as the proportion of children 12 to 15 months of age who are fed breast milk (37). Diet diversity score, a continuous variable estimated among children aged 6 to 23 months, was based on the aforementioned 7 foods groups used to calculate MDD (37). For each of the 7 food groups, children received 1 point if any food in the group was consumed (i.e. minimum DDS =0, maximum DDS =7). Minimum acceptable diet was modeled as a binary variable and was defined as the proportion of children 6 to 23 months of age who received a minimum acceptable diet as determined by minimum food frequency, diet diversity, and breastfeeding status (37). Because in some cases the within-country sample size for the associations between employment and EBF were somewhat smaller, we also employed a single logistic regression model with all 40 countries to test the association between employment and EBF. In this specification, each country was included as a fixed-effect, and therefore controlled for baseline country-level differences; but this model assumes the association between employment and EBF is homogeneous across countries. Alpha was set to 0.05. Analyses were performed using Stata 14.1 (StataCorp LP, College Station, Texas). No institutional review board review was obtained given that all analyses used secondary data.
- Conditions
- Feeding Behavior, Maternal Health
- Medical subject headings
- Feeding Behavior
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 |
|---|---|---|
| Fomally Employed | Mother engaged in formal employment. No intervention was assigned as this is a cross sectional study. | |
| Informally Employed | Mother engaged in informal employment. No intervention was assigned as this is a cross sectional study. | |
| Non-employed | Mother neither formally or informally employed. No intervention was assigned as this is a cross sectional study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive Breastfeeding
Prevalence odds of exclusive breastfeeding among children under 6 months
Measured: 0 to 6 months
Secondary outcomes (2)
Minimum Dietary Diversity
Prevalence odds of minimum dietary diversity among children 6 to 23 months
Measured: 6 to 23 months
Minimum Meal Frequency
Prevalence odds of minimum meal frequency among children 6 to 23 months
Measured: 6 to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jan 2017
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 39,791 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Ickes, University of Washington
- Investigators
- Scott B Ickes, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209999
- Sponsor's protocol ID
- UWashington
- Status last verified
- Jul 2017
- First submitted
- 3 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oddo VM, Ickes SB. Maternal employment in low- and middle-income countries is associated with improved infant and young child feeding. Am J Clin Nutr. 2018 Mar 1;107(3):335-344. doi: 10.1093/ajcn/nqy001.
PubMed 29566201
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Employment in Low and Middle-income Countries is Associated With Improved Infant and Young Child Feeding in Children
- ClinicalTrials.gov ID
- NCT03209999
- Acronym / sponsor ID
- UWashington
- Conditions
- Feeding Behavior, Maternal Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,791 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 6 Jul 2017 (actual)
- 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.
Using cross-sectional samples from over 40 Demographic and Health Surveys, the investigators studied the association between maternal employment and 3 indicators of Infant and Young Child Feeding (IYCF): exclusive breastfeeding (EBF) among children less than 6 months old (N=39,791) and minimum diet diversity (MDD) and minimum meal frequency (MMF) (N=137,208) among children 6 to 23 months old. Mothers were categorized as formally employed, informally employed, or non-employed. The investigators first used adjusted logistic regression models to assess the associations within each country. The investigators then used meta-analysis to pool associations across all countries and by region.
Detailed description
Data Source and Population
The investigators analyzed cross-sectional data from the Demographic and Health Surveys (DHS). DHS surveys employ standardized questionnaires and nationally representative, multi-stage cluster sampling to allow for cross-country comparisons (34).
Our study included DHS datasets that were administered between 2010 and April 2017 and that contained data on women's employment status and indicators of IYCF. Analyses included women who had at least one child between ages 0-24 months. If mothers had more than one child, the investigators included the youngest child in the household. Children residing outside the household were excluded.
In models that evaluated MDD and MMF as the dependent variables, the final analytic sample included 137,208 children aged 6 to 23 months from 50 countries. Small cell sizes were prohibitive to exploring the employment-EBF associations in 10 countries that met the aforementioned inclusion criteria; therefore, when modeling EBF as the dependent variable, the final analytic sample included 39,791 children aged 0 to 5 months in 40 countries.
Primary Dependent Variables
EBF, MDD, and MMF served as the primary dependent variables of interest as prior literature suggests changes in women's income and time, stemming from women's employment, may affect these indicators of IYCF. These indicators were created using data from the 24-hour recall of foods/food groups available in DHS. EBF, a binary variable, was defined as the proportion of infants 0 to 5 months of age who were fed exclusively with breast milk. MDD, a binary variable, was defined as proportion of children 6 to 23 months of age who received foods from 4 or more of the following 7 food groups: grains, roots and tubers; legumes and nuts; dairy products (milk, yogurt, cheese); flesh foods (meat, fish, poultry and liver/organ meats); eggs; vitamin-A rich fruits and vegetables; and other fruits and vegetables. MMF, a binary variable, was defined as the proportion of breastfed and non-breastfed children 6 to 23 months of age who receive solid, semi-solid, or soft foods the minimum number of times or more. For breastfed children, the minimum number of times varies with age (2 times if 6 to 8 months and 3 times if 9 to 23 months). Non-breastfed children ages 6 to 23 months must be fed 4 or more times per day to meet the MMF indicator.
Primary Independent Variable
The investigators modeled maternal employment as a 3-category variable: formally employed, informally employed, and non-employed based on prior research which suggests: 1) a large proportion of women in LMIC are engaged in less formalized employment and 2) wages earned are more than 60% lower in the informal sector. Women are described as non-employed because this term includes persons who choose to not seek employment whereas unemployed describes persons without jobs who are actively seeking employment.
Employment type was defined based on 4 indicators: 1) employment status in the last 12 months (employed, non-employed); 2) aggregate occupation category (skilled, unskilled); 3) type of earnings (cash only, cash and in-kind, in-kind only, unpaid); and 4) seasonality of employment (all year, seasonal/occasional employment). Formal employment included the following 3 combinations: 1) employed, skilled occupation, cash only earnings, employed all year; 2) employed, skilled occupation, cash only earnings, seasonal/occasional employment; and 3) employed, unskilled occupation, cash only earnings, employed all year. Other employed women were categorized as informally employed.
Confounders and Effect Measure Modifiers
The investigators identified confounding factors a priori using a directed acyclic graph, which is a causal diagram used to characterize the relationship among variables that influence the primary independent and the dependent variables based on both theorized and documented relationships. In all models, confounders included maternal education (< primary school complete, [Symbol] primary school complete), maternal age (years), marital status (married or living together versus single, widowed, divorced), parity, morbidity (presence of diarrhea or fever in the last two weeks), child age (months), and urban/rural status. The investigators aimed to specify covariates in a way that allowed for the same specification in each country and for each outcome. For variables that were in their continuous form in the DHS (maternal age, child age, parity), the investigators assessed their linearity with the outcomes by specifying disjoint indicator variables. Because variables were approximately linearly associated with the outcomes in most countries, they were retained in their continuous form to minimize the number of observations dropped from the model due to small cell sizes. Marital status and maternal education were dichotomized because there were very few people in some categories (e.g. divorced).
The investigators hypothesized that the employment-diet association would vary by countries' stage in the nutrition transition. Therefore, the investigators explored differences in the country-level associations by log-gross domestic product (GDP) per capita, adjusted for purchasing power parity, a theorized driver of the nutrition transition (41). Data were obtained from the World Development Indicators database, corresponding to the survey year (42). GDP-per capita was log-transformed to reflect the expected influence of a percent increase (e.g. 5%), rather than an absolute dollar increase (e.g. $5).
Statistical Analysis
Within-country analyses. It is expected that trends in employment (i.e. the percent of women in formal versus informal employment) as well as diet to differ depending on countries' stage of the nutrition transition. Therefore, the investigators aimed to keep samples comparable by selecting countries with a recent DHS (2010-2017) and we allowed for different relationships in each country by starting with disaggregate, country-specific estimates. The investigators first employed separate multivariable logistic regression models for each country to test the association between maternal employment and IYCF indicators (EBF, MDD, MMF). In these country-specific models, the investigators utilized sampling weights to account for differential probability of selection and response and Taylor series linearized standard errors accounted for DHS' clustered design.
Between-country and region analyses. After obtaining disaggregated estimates for each country, coefficients for the employment-EBF, employment-MDD, and employment-MMF associations were entered into a random effects meta-analysis to obtain odds ratios pooled across all countries and by world region (East Asia and Pacific, Europe and Central Asia, Latin American and Caribbean, Middle East and North Africa, South Asia, and sub-Saharan Africa). Random effects meta-analysis, used to generate pooled odds ratios (POR), is the statistical combination of the estimates from separate countries and assumes that the associations between employment and IYCF may differ by country and/or region.
Country-specific beta coefficients were also entered into a random-effects meta-regression to assess whether the associations between employment and IYCF varied by country-level log-GDP.
Sensitivity Analyses. Sensitivity analyses included modeling several alternative outcomes including: 1) continued breastfeeding at 1 year, 2) diet diversity score, and 3) minimum acceptable diet. Continued breastfeeding at 1 year, a binary variable, was defined as the proportion of children 12 to 15 months of age who are fed breast milk (37). Diet diversity score, a continuous variable estimated among children aged 6 to 23 months, was based on the aforementioned 7 foods groups used to calculate MDD (37). For each of the 7 food groups, children received 1 point if any food in the group was consumed (i.e. minimum DDS =0, maximum DDS =7). Minimum acceptable diet was modeled as a binary variable and was defined as the proportion of children 6 to 23 months of age who received a minimum acceptable diet as determined by minimum food frequency, diet diversity, and breastfeeding status (37). Because in some cases the within-country sample size for the associations between employment and EBF were somewhat smaller, we also employed a single logistic regression model with all 40 countries to test the association between employment and EBF. In this specification, each country was included as a fixed-effect, and therefore controlled for baseline country-level differences; but this model assumes the association between employment and EBF is homogeneous across countries. Alpha was set to 0.05. Analyses were performed using Stata 14.1 (StataCorp LP, College Station, Texas). No institutional review board review was obtained given that all analyses used secondary data.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fomally Employed | – | –Mother engaged in formal employment. No intervention was assigned as this is a cross sectional study. |
| Informally Employed | – | –Mother engaged in informal employment. No intervention was assigned as this is a cross sectional study. |
| Non-employed | – | –Mother neither formally or informally employed. No intervention was assigned as this is a cross sectional study. |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Maternal-child dyads within one of 50 low and middle-income countries with a Demographic and Health Survey since 2010
Key inclusion criteria (2 listed)
- Last born child, ages 1 to < 24 months
- Child living with mother
Key exclusion criteria (2 listed)
- Complete data available for maternal employment, children's dietary diversity, minimum meal frequency data
- Complete covariates available for maternal education, maternal age, marital status, parity, morbidity in the past 2 weeks, child age, and urban/rural status
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
Exclusive Breastfeeding
Time frame: 0 to 6 months
Prevalence odds of exclusive breastfeeding among children under 6 months
2 secondary outcomes
Minimum Dietary Diversity
Time frame: 6 to 23 months
Minimum Meal Frequency
Time frame: 6 to 23 months
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 11 Jul 2017.
- Derived from this study: PubMed 29566201Oddo VM, Ickes SB. Maternal employment in low- and middle-income countries is associated with improved infant and young child feeding. Am J Clin Nutr. 2018 Mar 1;107(3):335-344. doi: 10.1093/ajcn/nqy001.
- Individual participant dataSharing planned: No
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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.
Scott B Ickes, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding Behavior and Maternal Health, run by University of Washington at 1 site in United States.
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 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Exclusive Breastfeeding (time frame: 0 to 6 months). 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 NCT03209999, which also lists 1 linked publication.
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 11 Jul 2017.