- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473312
Women Supporting Women to Improve Infant and Child Feeding Practices
Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan
Study Overview
Status
Conditions
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:
- Understand local perceptions, experiences, cultural norms around IYCF practices and care,
- Discover demonstrably successful IYCF behaviours and strategies using local resources,
- Develop and implement a culturally appropriate and context specific intervention, and
- Evaluate the intervention.
Approaches: This population health research will take place in two rural communities (tehsils) of Rahim Yar Khan District, Punjab, Pakistan. The tehsils will be randomly selected to either control or intervention. A community-based approach is being used to engage the community in planning, development, implementation and evaluation. Study activities will involve (1) formative research (focus groups and household inquiry/observation) to identify PD IYCF practices, (2) development of a behaviour change intervention informed by the formative research data, (3) delivery of the intervention to mothers and fathers of malnourished children using community sensitization events, print information, and home-like settings for mothers to learn and practice the new behaviours, and (4) a quasi-experimental design using focus groups, household surveys, and children's growth patterns to evaluate the intervention.
Expertise: Our research team includes Canadian and Pakistani experts in community-based research, global health, behaviour change, qualitative and quantitative methods, and child nutrition, with a deep understanding of the community's beliefs concerning health and nutrition.
Expected Outcomes: The project will strategically position our team to guide efforts in Pakistan to improve undernutrition, with the potential to expand this work to other LMICs where our team is affiliated, such as Afghanistan and Uganda. This proposal is aligned with CIHR's mandate to advance global health research that addresses health inequities in LMICs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sajid Soofi
- Phone Number: +922134864798
- Email: sajid.soofi@aku.edu
Study Locations
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-
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Rahim Yar Khan, Pakistan
- Recruiting
- Aga Khan University Reseach Office
-
Contact:
- Gul Nawaz
- Email: gul.nawaz@aku.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
|
One event will be developed and delivered for households in each cluster area.
Approach and content will be informed by the formative research and CAC input (may include drama and nutrition fairs).
Mothers will come together in a home-like setting to rehabilitate their malnourished child (8 dyads/Hearth), learn and practice new feeding and childcare behaviours (during Covid-19: 4 dyads/Hearth).
Curriculum and activities will be informed by CAC, CORE Guide and formative research.
Two female facilitators will demonstrate, encourage, convey key messages and guide practices.
The content will be informed by the formative research and CAC, will reinforce Hearth messages, and be adapted for each gender group.
Material will be locally produced, engaging, user friendly, and target an illiterate audience (i.e.
culturally relevant images with minimal text).
|
No Intervention: Control
Control households will continue with usual practices.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child weight
Time Frame: Day 1 of each Hearth/home cycle
|
Child weight measurement in kilograms
|
Day 1 of each Hearth/home cycle
|
Child weight
Time Frame: Day 14 of each Hearth/home cycle
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Child weight measurement in kilograms
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Day 14 of each Hearth/home cycle
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Child weight
Time Frame: Day 28 of each Hearth/home cycle
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Child weight measurement in kilograms
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Day 28 of each Hearth/home cycle
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Child weight
Time Frame: Monthly for a total of 12 months
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Child weight measurement in kilograms
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Monthly for a total of 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child length
Time Frame: Day 1 of each Hearth/home cycle
|
Child length measurement in centimeters
|
Day 1 of each Hearth/home cycle
|
Child length
Time Frame: Day 14 of each Hearth/home cycle
|
Child length measurement in centimeters
|
Day 14 of each Hearth/home cycle
|
Child length
Time Frame: Day 28 of each Hearth/home cycle
|
Child length measurement in centimeters
|
Day 28 of each Hearth/home cycle
|
Child length
Time Frame: Monthly for a total of 12 months
|
Child length measurement in centimeters
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Monthly for a total of 12 months
|
Prevalence of infant and young child feeding knowledge and practices
Time Frame: At baseline
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Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
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At baseline
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Change in infant and young child feeding knowledge and practices
Time Frame: At 6 months
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Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
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At 6 months
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Change in infant and young child feeding knowledge and practices
Time Frame: At 12 months
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Infant and young child feeding knowledge and practices will be measured at using household survey questionnaire
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At 12 months
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Prevalence of child care knowledge and practices
Time Frame: At baseline
|
Child care knowledge and practices will be measured using household survey questionnaire
|
At baseline
|
Change in child care knowledge and practices
Time Frame: At 6 months
|
Child care knowledge and practices will be measured using household survey questionnaire
|
At 6 months
|
Change in child care knowledge and practices
Time Frame: At 12 months
|
Child care knowledge and practices will be measured using household survey questionnaire
|
At 12 months
|
Prevalence of hygiene knowledge and practices
Time Frame: At baseline
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Hygiene knowledge and practices will be measured using household survey questionnaire
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At baseline
|
Change in hygiene knowledge and practices
Time Frame: At 6 months
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Hygiene knowledge and practices will be measured using household survey questionnaire
|
At 6 months
|
Change in hygiene knowledge and practices
Time Frame: At 12 months
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Hygiene knowledge and practices will be measured using household survey questionnaire
|
At 12 months
|
Prevalence of health-seeking knowledge and practices
Time Frame: At baseline
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Health-seeking knowledge and practices will be measured using household survey questionnaire
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At baseline
|
Change in health-seeking knowledge and practices
Time Frame: At 6 months
|
Health-seeking knowledge and practices will be measured using household survey questionnaire
|
At 6 months
|
Change in health-seeking knowledge and practices
Time Frame: At 12 months
|
Health-seeking knowledge and practices will be measured using household survey questionnaire
|
At 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IYCF Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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