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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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:
- 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.
- Conditions
- Undernutrition, Healthy Nutrition, Health Behavior, Health Knowledge, Attitudes, Practice, Child Malnutrition, Child Rearing
- 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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 1. 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 |
| Control | No intervention | Control households will continue with usual practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child weight
Child weight measurement in kilograms
Measured: Day 1 of each Hearth/home cycle
Child weight
Child weight measurement in kilograms
Measured: Day 14 of each Hearth/home cycle
Child weight
Child weight measurement in kilograms
Measured: Day 28 of each Hearth/home cycle
Child weight
Child weight measurement in kilograms
Measured: Monthly for a total of 12 months
Secondary outcomes (16)
Child length
Child length measurement in centimeters
Measured: Day 1 of each Hearth/home cycle
Child length
Child length measurement in centimeters
Measured: Day 14 of each Hearth/home cycle
Child length
Child length measurement in centimeters
Measured: Day 28 of each Hearth/home cycle
Child length
Child length measurement in centimeters
Measured: Monthly for a total of 12 months
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
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
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
Prevalence of child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Measured: At baseline
Change in child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Measured: At 6 months
Change in child care knowledge and practices
Child care knowledge and practices will be measured using household survey questionnaire
Measured: At 12 months
Prevalence of hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Measured: At baseline
Change in hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Measured: At 6 months
Change in hygiene knowledge and practices
Hygiene knowledge and practices will be measured using household survey questionnaire
Measured: At 12 months
Prevalence of health-seeking knowledge and practices
Health-seeking knowledge and practices will be measured using household survey questionnaire
Measured: At baseline
Change in health-seeking knowledge and practices
Health-seeking knowledge and practices will be measured using household survey questionnaire
Measured: At 6 months
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.
- First posted25 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr Sajid Bashir Soofi, Aga Khan University
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