Clinical trial NCT05473312: 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
Overall status: RECRUITING
Phase: NA
Conditions: Undernutrition
Healthy Nutrition
Health Behavior
Health Knowledge, Attitudes, Practice
Child Malnutrition
Child Rearing
Health Care Seeking Behavior
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-07-25
Enrollment: 350
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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).

Primary outcomes:
measure: Child weight
timeFrame: Day 1 of each Hearth/home cycle
measure: Child weight
timeFrame: Day 14 of each Hearth/home cycle
measure: Child weight
timeFrame: Day 28 of each Hearth/home cycle
measure: Child weight
timeFrame: Monthly for a total of 12 months
Secondary outcomes:
measure: Child length
timeFrame: Day 1 of each Hearth/home cycle
measure: Child length
timeFrame: Day 14 of each Hearth/home cycle
measure: Child length
timeFrame: Day 28 of each Hearth/home cycle
measure: Child length
timeFrame: Monthly for a total of 12 months
measure: Prevalence of infant and young child feeding knowledge and practices
timeFrame: At baseline
measure: Change in infant and young child feeding knowledge and practices
timeFrame: At 6 months
measure: Change in infant and young child feeding knowledge and practices
timeFrame: At 12 months
measure: Prevalence of child care knowledge and practices
timeFrame: At baseline
measure: Change in child care knowledge and practices
timeFrame: At 6 months
measure: Change in child care knowledge and practices
timeFrame: At 12 months
measure: Prevalence of hygiene knowledge and practices
timeFrame: At baseline
measure: Change in hygiene knowledge and practices
timeFrame: At 6 months
measure: Change in hygiene knowledge and practices
timeFrame: At 12 months
measure: Prevalence of health-seeking knowledge and practices
timeFrame: At baseline
measure: Change in health-seeking knowledge and practices
timeFrame: At 6 months
measure: Change in health-seeking knowledge and practices
timeFrame: At 12 months
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Aga Khan University Reseach Office
Study officials:
References: