Women Supporting Women to Improve Infant and Child Feeding Practices
Primary Purpose
Undernutrition, Healthy Nutrition, Health Behavior
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Community Sensitization
28-day PD/Hearth Sessions
Supplemental Print Information
Sponsored by
About this trial
This is an interventional prevention trial for Undernutrition
Eligibility Criteria
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).
Sites / Locations
- Aga Khan University Reseach OfficeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Community Sensitization 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice) Supplemental Print Information
Control households will continue with usual practices.
Outcomes
Primary Outcome Measures
Child weight
Child weight measurement in kilograms
Child weight
Child weight measurement in kilograms
Child weight
Child weight measurement in kilograms
Child weight
Child weight measurement in kilograms
Secondary Outcome Measures
Child length
Child length measurement in centimeters
Child length
Child length measurement in centimeters
Child length
Child length measurement in centimeters
Child length
Child length measurement in centimeters
Prevalence of infant and young child feeding knowledge and practices
Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
Change in infant and young child feeding knowledge and practices
Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
Change in infant and young child feeding knowledge and practices
Infant and young child feeding knowledge and practices will be measured at using household survey questionnaire
Prevalence of child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Change in child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Change in child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Prevalence of hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Change in hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Change in hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Prevalence of health-seeking knowledge and practices
Health-seeking knowledge and practices will be measured using household survey questionnaire
Change in health-seeking knowledge and practices
Health-seeking knowledge and practices will be measured using household survey questionnaire
Change in health-seeking knowledge and practices
Health-seeking knowledge and practices will be measured using household survey questionnaire
Full Information
NCT ID
NCT05473312
First Posted
April 12, 2022
Last Updated
August 15, 2023
Sponsor
Aga Khan University
Collaborators
University of British Columbia, Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT05473312
Brief Title
Women Supporting Women to Improve Infant and Child Feeding Practices
Official Title
Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
University of British Columbia, Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undernutrition, Healthy Nutrition, Health Behavior, Health Knowledge, Attitudes, Practice, Child Malnutrition, Child Rearing, Health Care Seeking Behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Community Sensitization
28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice)
Supplemental Print Information
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control households will continue with usual practices.
Intervention Type
Behavioral
Intervention Name(s)
Community Sensitization
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
28-day PD/Hearth Sessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Supplemental Print Information
Intervention Description
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).
Primary Outcome Measure Information:
Title
Child weight
Description
Child weight measurement in kilograms
Time Frame
Day 1 of each Hearth/home cycle
Title
Child weight
Description
Child weight measurement in kilograms
Time Frame
Day 14 of each Hearth/home cycle
Title
Child weight
Description
Child weight measurement in kilograms
Time Frame
Day 28 of each Hearth/home cycle
Title
Child weight
Description
Child weight measurement in kilograms
Time Frame
Monthly for a total of 12 months
Secondary Outcome Measure Information:
Title
Child length
Description
Child length measurement in centimeters
Time Frame
Day 1 of each Hearth/home cycle
Title
Child length
Description
Child length measurement in centimeters
Time Frame
Day 14 of each Hearth/home cycle
Title
Child length
Description
Child length measurement in centimeters
Time Frame
Day 28 of each Hearth/home cycle
Title
Child length
Description
Child length measurement in centimeters
Time Frame
Monthly for a total of 12 months
Title
Prevalence of infant and young child feeding knowledge and practices
Description
Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
Time Frame
At baseline
Title
Change in infant and young child feeding knowledge and practices
Description
Infant and young child feeding knowledge and practices will be measured using household survey questionnaire
Time Frame
At 6 months
Title
Change in infant and young child feeding knowledge and practices
Description
Infant and young child feeding knowledge and practices will be measured at using household survey questionnaire
Time Frame
At 12 months
Title
Prevalence of child care knowledge and practices
Description
Child care knowledge and practices will be measured using household survey questionnaire
Time Frame
At baseline
Title
Change in child care knowledge and practices
Description
Child care knowledge and practices will be measured using household survey questionnaire
Time Frame
At 6 months
Title
Change in child care knowledge and practices
Description
Child care knowledge and practices will be measured using household survey questionnaire
Time Frame
At 12 months
Title
Prevalence of hygiene knowledge and practices
Description
Hygiene knowledge and practices will be measured using household survey questionnaire
Time Frame
At baseline
Title
Change in hygiene knowledge and practices
Description
Hygiene knowledge and practices will be measured using household survey questionnaire
Time Frame
At 6 months
Title
Change in hygiene knowledge and practices
Description
Hygiene knowledge and practices will be measured using household survey questionnaire
Time Frame
At 12 months
Title
Prevalence of health-seeking knowledge and practices
Description
Health-seeking knowledge and practices will be measured using household survey questionnaire
Time Frame
At baseline
Title
Change in health-seeking knowledge and practices
Description
Health-seeking knowledge and practices will be measured using household survey questionnaire
Time Frame
At 6 months
Title
Change in health-seeking knowledge and practices
Description
Health-seeking knowledge and practices will be measured using household survey questionnaire
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
9 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sajid Soofi
Phone
+922134864798
Email
sajid.soofi@aku.edu
Facility Information:
Facility Name
Aga Khan University Reseach Office
City
Rahim Yar Khan
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gul Nawaz
Email
gul.nawaz@aku.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Women Supporting Women to Improve Infant and Child Feeding Practices
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