NCT03406182

Brief 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. 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

  1. 1.To determine whether the number of hours a mother participates in agriculture work is associated with maternal body mass index and infant nutrition.
  2. 2.To identify factors that modify the influence of maternal participation in agriculture work on maternal and infant nutritional status.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,161

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

1 month

First QC Date

December 12, 2017

Last Update Submit

January 19, 2018

Conditions

Keywords

stuntingunder-weightPakistaninfanttime-usewomenbody mass indexgrowth

Outcome Measures

Primary Outcomes (2)

  • Body mass index

    maternal weight divided by height squared

    First survey (December 2015-February 2016)

  • Body mass index

    maternal weight divided by height squared

    Second survey (November-January 2017)

Secondary Outcomes (2)

  • Change in length-for-age Z-score

    first survey (December 2015-February 2016) and second survey (November 2016-January 2017)

  • Infant and young child minimum dietary diversity (IYCMDD) score

    second survey (November 2016-January 2017)

Eligibility Criteria

Age2 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Community sample. Mother-infant dyads living in rural Sindh province, Pakistan. They were selected from 62 administrative villages with perennial canal irrigation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Collective for Social Science Research

Karachi, Pakistan

Location

London School of Hygiene & Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

MalnutritionGrowth Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

January 23, 2018

Study Start

December 30, 2015

Primary Completion

February 2, 2016

Study Completion

February 1, 2017

Last Updated

January 23, 2018

Record last verified: 2017-12

Locations