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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women Supporting Women Using Local Solutions to Improve Infant and Young Child Feeding and Care Practices in Punjab, Pakistan
- ClinicalTrials.gov ID
- NCT05473312
- Acronym / sponsor ID
- IYCF Study
- Conditions
- Undernutrition, Healthy Nutrition, Health Behavior, Health Knowledge, Attitudes, Practice, Child Malnutrition, Child Rearing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Community Sensitization, Behavioral: 28-day PD/Hearth Sessions, Behavioral: Supplemental Print Information1. Community Sensitization 2. 28-day behaviour practice (Positive Deviance (PD) /Hearth sessions plus home practice) 3. Supplemental Print Information |
| Control | No intervention | –Control households will continue with usual practices. |
Who may qualify
- Ages
- 7 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Any disability that precludes providing informed consent, transient, < 18 yrs (legal consent age).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community SensitizationOne 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). | Behavioural | Intervention |
| 28-day PD/Hearth SessionsMothers 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. | Behavioural | Intervention |
| Supplemental Print InformationThe 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). | Behavioural | Intervention |
Primary outcome
Child weight
Time frame: Day 1 of each Hearth/home cycle
Child weight measurement in kilograms
Child weight
Time frame: Day 14 of each Hearth/home cycle
Child weight measurement in kilograms
Child weight
Time frame: Day 28 of each Hearth/home cycle
Child weight measurement in kilograms
Child weight
Time frame: Monthly for a total of 12 months
Child weight measurement in kilograms
16 secondary outcomes
Child length
Time frame: Day 1 of each Hearth/home cycle
Child length
Time frame: Day 14 of each Hearth/home cycle
Child length
Time frame: Day 28 of each Hearth/home cycle
Child length
Time frame: Monthly for a total of 12 months
Prevalence of infant and young child feeding knowledge and practices
Time frame: At baseline
Change in infant and young child feeding knowledge and practices
Time frame: At 6 months
Change in infant and young child feeding knowledge and practices
Time frame: At 12 months
Prevalence of child care knowledge and practices
Time frame: At baseline
Change in child care knowledge and practices
Time frame: At 6 months
Change in child care knowledge and practices
Time frame: At 12 months
Prevalence of hygiene knowledge and practices
Time frame: At baseline
Change in hygiene knowledge and practices
Time frame: At 6 months
Change in hygiene knowledge and practices
Time frame: At 12 months
Prevalence of health-seeking knowledge and practices
Time frame: At baseline
Change in health-seeking knowledge and practices
Time frame: At 6 months
Change in health-seeking knowledge and practices
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child weight (time frame: Day 1 of each Hearth/home cycle). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.