Women Supporting Women to Improve Infant and Child Feeding Practices

Sponsor
Aga Khan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05473312
Collaborator
University of British Columbia (Other), Canadian Institutes of Health Research (CIHR) (Other)
350
2
39

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Community Sensitization
  • Behavioral: 28-day PD/Hearth Sessions
  • Behavioral: Supplemental Print Information
N/A

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:
  1. Understand local perceptions, experiences, cultural norms around IYCF practices and care,

  2. Discover demonstrably successful IYCF behaviours and strategies using local resources,

  3. Develop and implement a culturally appropriate and context specific intervention, and

  4. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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

Behavioral: Community Sensitization
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).

Behavioral: 28-day PD/Hearth Sessions
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.

Behavioral: Supplemental Print Information
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.

Outcome Measures

Primary Outcome Measures

  1. Child weight [Day 1 of each Hearth/home cycle]

    Child weight measurement in kilograms

  2. Child weight [Day 14 of each Hearth/home cycle]

    Child weight measurement in kilograms

  3. Child weight [Day 28 of each Hearth/home cycle]

    Child weight measurement in kilograms

  4. Child weight [Monthly for a total of 12 months]

    Child weight measurement in kilograms

Secondary Outcome Measures

  1. Child length [Day 1 of each Hearth/home cycle]

    Child length measurement in centimeters

  2. Child length [Day 14 of each Hearth/home cycle]

    Child length measurement in centimeters

  3. Child length [Day 28 of each Hearth/home cycle]

    Child length measurement in centimeters

  4. Child length [Monthly for a total of 12 months]

    Child length measurement in centimeters

  5. Prevalence of infant and young child feeding knowledge and practices [At baseline]

    Infant and young child feeding knowledge and practices will be measured using household survey questionnaire

  6. Change in infant and young child feeding knowledge and practices [At 6 months]

    Infant and young child feeding knowledge and practices will be measured using household survey questionnaire

  7. Change in infant and young child feeding knowledge and practices [At 12 months]

    Infant and young child feeding knowledge and practices will be measured at using household survey questionnaire

  8. Prevalence of child care knowledge and practices [At baseline]

    Child care knowledge and practices will be measured using household survey questionnaire

  9. Change in child care knowledge and practices [At 6 months]

    Child care knowledge and practices will be measured using household survey questionnaire

  10. Change in child care knowledge and practices [At 12 months]

    Child care knowledge and practices will be measured using household survey questionnaire

  11. Prevalence of hygiene knowledge and practices [At baseline]

    Hygiene knowledge and practices will be measured using household survey questionnaire

  12. Change in hygiene knowledge and practices [At 6 months]

    Hygiene knowledge and practices will be measured using household survey questionnaire

  13. Change in hygiene knowledge and practices [At 12 months]

    Hygiene knowledge and practices will be measured using household survey questionnaire

  14. Prevalence of health-seeking knowledge and practices [At baseline]

    Health-seeking knowledge and practices will be measured using household survey questionnaire

  15. Change in health-seeking knowledge and practices [At 6 months]

    Health-seeking knowledge and practices will be measured using household survey questionnaire

  16. Change in health-seeking knowledge and practices [At 12 months]

    Health-seeking knowledge and practices will be measured using household survey questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Months to 9 Months
Sexes Eligible for Study:
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Aga Khan University
  • University of British Columbia
  • Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Sajid Bashir Soofi, Professor, Aga Khan University
ClinicalTrials.gov Identifier:
NCT05473312
Other Study ID Numbers:
  • IYCF Study
First Posted:
Jul 25, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022