MalnutritionWWANNCT03406182
Women's Work in Agriculture and Infant Nutrition
An observational study of Malnutrition, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
Trial summary
Background Over the last 10 years there has been an increase in the female agriculture labour force, in Pakistan, resulting in a feminisation of agriculture; which could have either a positive or negative impact on maternal and young child nutrition. Read more about this study
- Who is it for?
- Ages 2 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- How many people
- 1,161 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Dec 2015to 1 Feb 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 2 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample. Mother-infant dyads living in rural Sindh province, Pakistan. They were selected from 62 administrative villages with perennial canal irrigation.
Who may be able to join
- Infant aged ≥ 2 weeks and ≤ 12weeks of age on the day of the first interview
- Infant is apparently healthy without congenital deformations that effect their ability to eat and grow
- The primary caregiver (i.e. biological mother) intended to reside in the study area over the next 10 months.
Who cannot join
- Infant aged ≤ 2 weeks and ≥ 12weeks of age on the day of the first interview
- Infant with congenital deformations that effect their ability to eat and grow
- The primary caregiver is not the biological mother)
- The primary caregiver not intending to reside in the study area over the next 10 months.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
London School of Hygiene & Tropical Medicine
London, WC1E 7HT
About this study
Official title: The Relationship Between Women's Workload in Agriculture and Infant Nutritional Status in Rural Sindh, Pakistan
Background Over the last 10 years there has been an increase in the female agriculture labour force, in Pakistan, resulting in a feminisation of agriculture; which could have either a positive or negative impact on maternal and young child nutrition. It could have a positive impact through increased female wage earnings that improve her bargaining/decision-making power within the household. Women are more likely than men to make pro-nutrition choices with regards to household expenditure. Conversely, women's involvement in agricultural work may have a negative impact on infant or maternal nutrition by reducing time available for child care, through increased expenditure of physical energy without compensatory increases in food consumption or exposure to harmful toxins present in pesticides and other chemicals used in farming. Understanding the dynamics of these pathways, in a specific context, is important to ensure agriculture programmes and policies do not disadvantage women or their children.
Overall aim To provide insights into positive and negative pathways between women's work in agriculture and maternal and child nutritional status, in different agriculture workload contexts, to inform agriculture interventions and policies in Pakistan.
Read more
Specific Objectives
- To determine whether the number of hours a mother participates in agriculture work is associated with maternal body mass index and infant nutrition.
- To identify factors that modify the influence of maternal participation in agriculture work on maternal and infant nutritional status.
Study Design A cohort study was conducted from September 2015 in irrigated rural areas of Pakistan. Infant-mother dyads were recruited when the infant was between 2 and 12 weeks of age inclusive. Anthropometric measurements (maternal and infant height / recumbent length and weight), interviewer administered questionnaires and spot observations were collected at recruitment (Time 1) and again when the infants were between 9-15 months of age (Time 2). The interviewer administered questionnaires were collected from each infant's mother (or the household head if the father was not present). A one page questionnaire was also completed at recruitment to record the numbers of women who agreed to participate in the study, the number who were approached but were not recruited into the study and the reasons they were not eligible to participate or their reasons for refusal.
Read the detailed description
Study Design This study is an longitudinal observational study which was used to generate hypotheses rather than testing them. Mother-infant dyads were recruited between December 2015 and February 2016; and were followed up between November 2016 and January 2017.
Sampling The sample size (n=1000) was calculated to detect an increase/decrease in maternal BMI of around 0.18 for every additional hour worked with 80% power at a 5% level of significance. To estimate it, simulations were run to explore the power we would have to detect the relationship between maternal BMI and number of hours worked. It was based on a mean number of working hours of 6 and a standard deviation of 4 and a within cluster variation of 0.2 . This is a small effect size and suggests that the proposed sample size will provide adequate power to allow us to explore proposed relationships and generate hypotheses.
Participants were selected via systematic random cluster sampling. Initially, administrative villages with perennial canal irrigation were selected; villages with a population<10% or >90% of average village size were excluded, and random sampling was used to select villages from the eligible villages (n=2,909). All dyads, in the selected villages (n=62) were invited to participate in the study if: (i) the infant was a singleton birth ≥2 weeks and ≤ 12 weeks of age on the day of the first interview; healthy without congenital deformations that would impact on their ability to eat and (ii) the primary caregiver (i.e. the biological mother) intended to reside in the study area over the next 10 months.
To recruit these dyads, all recent births in the identified village were listed through a systematic multi-stage community profiling procedure using local key informants/resource persons including: health workers, midwives, doctors and paramedics, and locally well-informed individuals. In the first stage, several key informants per village were asked to exhaustively list all kinship groups or castes and localities within the village. Then they were asked to list all births from within those castes/localities within a given time period. Probes were used at both stages to counter exclusions. Afterwards a team of recruiters visited each of the listed mothers to confirm eligibility (i.e. correct age of the new born). Recruiters also probed for other births within the locality, to identify new cases through this snowballing technique. All dyads in the village who fulfilled this condition and met the inclusion criteria were recruited and actual date of birth was recorded.
Procedures and Methodology At each of the two data collection periods, interviewer administered questionnaires were collected from the mothers; and included questions related to socio-demographic status, health, dietary intakes, maternal agency and nutrition knowledge. These questionnaires were pilot tested and modified to ensure each questionnaire took less than 60 minutes per respondent to complete. For mothers, questions related to infant feeding, immunisation and pregnancy varied between the first and second data collection periods to reflect differences in infant age and maternal status. All data were entered directly into an android tablet.
Anthropometric measurements of maternal height and weight and infant weight and recumbent length were done in duplicate by trained anthropometrists using high quality equipment. If the first and second measurements did not agree to within a specified limit (e.g., 0.5 kg or 0.5 cm) a third measurement was taken. These data were entered directly into an android tablet to allow consistency checks for quality assurance. Spot observations were also done to determine housing materials and the hygienic conditions of the environment, which were entered directly into an android tablet.
- Conditions
- Malnutrition
- Keywords
- stunting, under-weight, Pakistan, infant, time-use, women, body mass index, growth
- Medical subject headings
- Malnutrition, Growth Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index
maternal weight divided by height squared
Measured: First survey (December 2015-February 2016)
Body mass index
maternal weight divided by height squared
Measured: Second survey (November-January 2017)
Secondary outcomes (2)
Change in length-for-age Z-score
infant length
Measured: first survey (December 2015-February 2016) and second survey (November 2016-January 2017)
Infant and young child minimum dietary diversity (IYCMDD) score
Scale measures the number of food groups in the infant's diet; the scale range is from 0 to 7 with higher values representing a better outcome.
Measured: second survey (November 2016-January 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start30 Dec 2015
- Primary completion2 Feb 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406182
- Sponsor's protocol ID
- 9647
- Acronym
- WWAN
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data set, if it is shared, will be fully anonymised. The duty of confidentiality will be maintained, because an individual cannot be identified from any shared data sets.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Women's Workload in Agriculture and Infant Nutritional Status in Rural Sindh, Pakistan
- ClinicalTrials.gov ID
- NCT03406182
- Acronym / sponsor ID
- WWAN / 9647
- Conditions
- Malnutrition
- Keywords
- stunting, under-weight, Pakistan, infant, time-use, women, body mass index, growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,161 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- 30 Dec 2015 (actual)
- Primary completion
- 2 Feb 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 23 Jan 2018 (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.
Background Over the last 10 years there has been an increase in the female agriculture labour force, in Pakistan, resulting in a feminisation of agriculture; which could have either a positive or negative impact on maternal and young child nutrition. It could have a positive impact through increased female wage earnings that improve her bargaining/decision-making power within the household. Women are more likely than men to make pro-nutrition choices with regards to household expenditure. Conversely, women's involvement in agricultural work may have a negative impact on infant or maternal nutrition by reducing time available for child care, through increased expenditure of physical energy without compensatory increases in food consumption or exposure to harmful toxins present in pesticides and other chemicals used in farming. Understanding the dynamics of these pathways, in a specific context, is important to ensure agriculture programmes and policies do not disadvantage women or their children.
Overall aim To provide insights into positive and negative pathways between women's work in agriculture and maternal and child nutritional status, in different agriculture workload contexts, to inform agriculture interventions and policies in Pakistan.
Specific Objectives
- To determine whether the number of hours a mother participates in agriculture work is associated with maternal body mass index and infant nutrition.
- To identify factors that modify the influence of maternal participation in agriculture work on maternal and infant nutritional status.
Study Design A cohort study was conducted from September 2015 in irrigated rural areas of Pakistan. Infant-mother dyads were recruited when the infant was between 2 and 12 weeks of age inclusive. Anthropometric measurements (maternal and infant height / recumbent length and weight), interviewer administered questionnaires and spot observations were collected at recruitment (Time 1) and again when the infants were between 9-15 months of age (Time 2). The interviewer administered questionnaires were collected from each infant's mother (or the household head if the father was not present). A one page questionnaire was also completed at recruitment to record the numbers of women who agreed to participate in the study, the number who were approached but were not recruited into the study and the reasons they were not eligible to participate or their reasons for refusal.
Detailed description
Study Design This study is an longitudinal observational study which was used to generate hypotheses rather than testing them. Mother-infant dyads were recruited between December 2015 and February 2016; and were followed up between November 2016 and January 2017.
Sampling The sample size (n=1000) was calculated to detect an increase/decrease in maternal BMI of around 0.18 for every additional hour worked with 80% power at a 5% level of significance. To estimate it, simulations were run to explore the power we would have to detect the relationship between maternal BMI and number of hours worked. It was based on a mean number of working hours of 6 and a standard deviation of 4 and a within cluster variation of 0.2 . This is a small effect size and suggests that the proposed sample size will provide adequate power to allow us to explore proposed relationships and generate hypotheses.
Participants were selected via systematic random cluster sampling. Initially, administrative villages with perennial canal irrigation were selected; villages with a population<10% or >90% of average village size were excluded, and random sampling was used to select villages from the eligible villages (n=2,909). All dyads, in the selected villages (n=62) were invited to participate in the study if: (i) the infant was a singleton birth ≥2 weeks and ≤ 12 weeks of age on the day of the first interview; healthy without congenital deformations that would impact on their ability to eat and (ii) the primary caregiver (i.e. the biological mother) intended to reside in the study area over the next 10 months.
To recruit these dyads, all recent births in the identified village were listed through a systematic multi-stage community profiling procedure using local key informants/resource persons including: health workers, midwives, doctors and paramedics, and locally well-informed individuals. In the first stage, several key informants per village were asked to exhaustively list all kinship groups or castes and localities within the village. Then they were asked to list all births from within those castes/localities within a given time period. Probes were used at both stages to counter exclusions. Afterwards a team of recruiters visited each of the listed mothers to confirm eligibility (i.e. correct age of the new born). Recruiters also probed for other births within the locality, to identify new cases through this snowballing technique. All dyads in the village who fulfilled this condition and met the inclusion criteria were recruited and actual date of birth was recorded.
Procedures and Methodology At each of the two data collection periods, interviewer administered questionnaires were collected from the mothers; and included questions related to socio-demographic status, health, dietary intakes, maternal agency and nutrition knowledge. These questionnaires were pilot tested and modified to ensure each questionnaire took less than 60 minutes per respondent to complete. For mothers, questions related to infant feeding, immunisation and pregnancy varied between the first and second data collection periods to reflect differences in infant age and maternal status. All data were entered directly into an android tablet.
Anthropometric measurements of maternal height and weight and infant weight and recumbent length were done in duplicate by trained anthropometrists using high quality equipment. If the first and second measurements did not agree to within a specified limit (e.g., 0.5 kg or 0.5 cm) a third measurement was taken. These data were entered directly into an android tablet to allow consistency checks for quality assurance. Spot observations were also done to determine housing materials and the hygienic conditions of the environment, which were entered directly into an android tablet.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample. Mother-infant dyads living in rural Sindh province, Pakistan. They were selected from 62 administrative villages with perennial canal irrigation.
Key inclusion criteria (3 listed)
- Infant aged ≥ 2 weeks and ≤ 12weeks of age on the day of the first interview
- Infant is apparently healthy without congenital deformations that effect their ability to eat and grow
- The primary caregiver (i.e. biological mother) intended to reside in the study area over the next 10 months.
Key exclusion criteria (4 listed)
- Infant aged ≤ 2 weeks and ≥ 12weeks of age on the day of the first interview
- Infant with congenital deformations that effect their ability to eat and grow
- The primary caregiver is not the biological mother)
- The primary caregiver not intending to reside in the study area over the next 10 months.
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
Body mass index
Time frame: First survey (December 2015-February 2016)
maternal weight divided by height squared
Body mass index
Time frame: Second survey (November-January 2017)
maternal weight divided by height squared
2 secondary outcomes
Change in length-for-age Z-score
Time frame: first survey (December 2015-February 2016) and second survey (November 2016-January 2017)
Infant and young child minimum dietary diversity (IYCMDD) score
Time frame: second survey (November 2016-January 2017)
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 23 Jan 2018.
- Individual participant dataSharing planned: Undecided. The data set, if it is shared, will be fully anonymised. The duty of confidentiality will be maintained, because an individual cannot be identified from any shared data sets.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by London School of Hygiene and Tropical Medicine at 2 sites in 2 countries.
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 4 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan, United Kingdom. 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?
Body mass index (time frame: First survey (December 2015-February 2016)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.