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Clinical Trials/NCT05473312
NCT05473312Active, not recruitingNot Applicable

Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan

Aga Khan University1 site in 1 country350 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
350
Locations
1
Primary Endpoint
Child weight

Study Overview

Brief Summary

Undernutrition in the first 2 years of life is the largest preventable cause of death before age 5. Among those who survive, stunting before age two leaves millions with lifelong physical and cognitive deficits, which are difficult to compensate for later in life. Pakistan is home to the second largest number of stunted children in South Asia. The primary goal of this study is to rehabilitate moderately malnourished children aged 7-23 months and enable mothers to sustain this healthy growth at home by changing their infant and young child feeding (IYCF) practices, child care, hygiene and health-seeking behaviours.

Detailed Description

Background and Rationale:

Undernutrition in the first 2 years of life is the largest preventable cause of death before age 5. Among those who survive, stunting before age two leaves millions with lifelong physical and cognitive deficits, which are difficult to compensate for later in life. Pakistan is home to the second largest number of stunted children in South Asia. COVID-19 is projected to increase the prevalence of child malnutrition by almost 14% in the coming year, the majority of which will be in low-middle income countries (LMICs) like Pakistan. In the last two decades, there has been a little reduction in the prevalence of child undernutrition in Pakistan compared to other LMICs. With four in ten children under 5 years of age stunted, one in three underweight, and one in five wasted, Pakistan is a priority country for action to improve infant and young child feeding (IYCF) and caring practices. We will identify uncommon but successful (i.e. Positive Deviant -PD) IYCF behaviours practiced by local mothers of well-nourished children from economically disadvantaged homes, and transfer these practices to mothers with undernourished children who are equally disadvantaged in the wider community.

Goals: To rehabilitate moderately malnourished children aged 7-23 months and enable mothers to sustain this healthy growth at home by changing their IYCF practices, child care, hygiene and health-seeking behaviours.

Hypothesis: A higher proportion of children in the intervention compared to the control group will experience an average weight gain of 400g/month in the first 4 months of the intervention.

Objectives:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
7 Months to 9 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Households with a moderately malnourished child (Index child) 7-9 month of age and both parents consenting using thumbprint or written signature (one dyad/household).

Exclusion Criteria

  • Any disability that precludes providing informed consent, transient, < 18 yrs (legal consent age).

Arms & Interventions

Intervention

Experimental
  1. Community Sensitization
  2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice)
  3. Supplemental Print Information

Intervention: Community Sensitization (Behavioral)

Intervention

Experimental
  1. Community Sensitization
  2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice)
  3. Supplemental Print Information

Intervention: 28-day PD/Hearth Sessions (Behavioral)

Intervention

Experimental
  1. Community Sensitization
  2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice)
  3. Supplemental Print Information

Intervention: Supplemental Print Information (Behavioral)

Control

No Intervention

Control households will continue with usual practices.

Outcomes

Primary Outcomes

Child weight

Time Frame: Monthly for a total of 12 months

Child weight measurement in kilograms

Child weight

Time Frame: Day 1 of each Hearth/home cycle

Child weight measurement in kilograms

Child weight

Time Frame: Day 14 of each Hearth/home cycle

Child weight measurement in kilograms

Child weight

Time Frame: Day 28 of each Hearth/home cycle

Child weight measurement in kilograms

Secondary Outcomes

  • Child length(Monthly for a total of 12 months)
  • Prevalence of child care knowledge and practices(At baseline)
  • Prevalence of infant and young child feeding knowledge and practices(At baseline)
  • Change in infant and young child feeding knowledge and practices(At 12 months)
  • Change in hygiene knowledge and practices(At 12 months)
  • Prevalence of health-seeking knowledge and practices(At baseline)
  • Change in child care knowledge and practices(At 12 months)
  • Prevalence of hygiene knowledge and practices(At baseline)
  • Change in health-seeking knowledge and practices(At 12 months)
  • Child length(Day 1 of each Hearth/home cycle)
  • Child length(Day 14 of each Hearth/home cycle)
  • Child length(Day 28 of each Hearth/home cycle)
  • Change in infant and young child feeding knowledge and practices(At 6 months)
  • Change in child care knowledge and practices(At 6 months)
  • Change in hygiene knowledge and practices(At 6 months)
  • Change in health-seeking knowledge and practices(At 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Sajid Bashir Soofi

Professor

Aga Khan University

Study Sites (1)

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