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UndernutritionNCT05473312

Women Supporting Women to Improve Infant and Child Feeding Practices

A study testing Community Sensitization, 28-day PD/Hearth Sessions and Supplemental Print Information in people with Undernutrition and Healthy Nutrition, run by Aga Khan University at 1 site in Pakistan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 7 to 9 months
Conditions the study is for
Undernutrition, Healthy Nutrition, Health Behavior
What is being tested?
Community Sensitization, 28-day PD/Hearth Sessions and Supplemental Print Information
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 sitePakistan
Study dates
1 Sep 2022to 30 Jun 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 9 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Aga Khan University Reseach Office

    Rahim Yar Khan

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
Community Sensitization, 28-day PD/Hearth Sessions, Supplemental Print Information
Medical subject headings
Malnutrition, Health Behavior, Behavior, Child Nutrition Disorders, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community SensitizationBehavioural

    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).

  • 28-day PD/Hearth SessionsBehavioural

    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.

  • Supplemental Print InformationBehavioural

    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).

Study groups in NCT05473312
Study groupRoleWhat they receive
InterventionExperimental1. Community Sensitization 2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice) 3. Supplemental Print Information
Receives: Behavioral: Community Sensitization; Behavioral: 28-day PD/Hearth Sessions; Behavioral: Supplemental Print Information
ControlNo interventionControl households will continue with usual practices.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Child weight

    Child weight measurement in kilograms

    Measured: Day 1 of each Hearth/home cycle

  2. Child weight

    Child weight measurement in kilograms

    Measured: Day 14 of each Hearth/home cycle

  3. Child weight

    Child weight measurement in kilograms

    Measured: Day 28 of each Hearth/home cycle

  4. Child weight

    Child weight measurement in kilograms

    Measured: Monthly for a total of 12 months

Secondary outcomes (16)
  1. Child length

    Child length measurement in centimeters

    Measured: Day 1 of each Hearth/home cycle

  2. Child length

    Child length measurement in centimeters

    Measured: Day 14 of each Hearth/home cycle

  3. Child length

    Child length measurement in centimeters

    Measured: Day 28 of each Hearth/home cycle

  4. Child length

    Child length measurement in centimeters

    Measured: Monthly for a total of 12 months

  5. 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

    Measured: At baseline

  6. 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

    Measured: At 6 months

  7. 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

    Measured: At 12 months

  8. Prevalence of child care knowledge and practices

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

    Measured: At baseline

  9. Change in child care knowledge and practices

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

    Measured: At 6 months

  10. Change in child care knowledge and practices

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

    Measured: At 12 months

  11. Prevalence of hygiene knowledge and practices

    Hygiene knowledge and practices will be measured using household survey questionnaire

    Measured: At baseline

  12. Change in hygiene knowledge and practices

    Hygiene knowledge and practices will be measured using household survey questionnaire

    Measured: At 6 months

  13. Change in hygiene knowledge and practices

    Hygiene knowledge and practices will be measured using household survey questionnaire

    Measured: At 12 months

  14. Prevalence of health-seeking knowledge and practices

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

    Measured: At baseline

  15. Change in health-seeking knowledge and practices

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

    Measured: At 6 months

  16. Change in health-seeking knowledge and practices

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

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start1 Sep 2022
  3. Primary completion30 Mar 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05473312
Sponsor's protocol ID
IYCF Study
Status last verified
Jan 2026
First submitted
12 Apr 2022
Last updated
27 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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