StuntingNCT06025786
Impact Evaluation of Benazir Nashonuma Program (BNP) on Stunting Among Under-five Children
A study testing Benazir Nashonuma Program (BNP) in people with Stunting and Wasting, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The aim of the study is to evaluate the impact of Benazir Nashonuma Program (BNP) on prevalence of stunting among under-five children in low income setting of Pakistan. The research question that the study aims to answer is: Is there any change in the prevalence of stunting among under-five children in districts where… Read more about this study
- Who is it for?
- Ages 1 day to 59 monthsHealthy volunteers can take part
- What is being tested?
- Benazir Nashonuma Program (BNP)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Mother of the child who is not a woman of reproductive age, i.e., less than 15 years or greater than 49 years
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 75290
Asma Abdul Malik, MBBS, MSc, +923311388051, asma.qureshi@aku.edu
Shah Mohammad, shah.muhammad@aku.edu
About this study
Official title: Impact Assessment of Benazir Nashonuma Program (BNP) on Stunting Prevention Among Children 0-59 Months of Age in Pakistan
The aim of the study is to evaluate the impact of Benazir Nashonuma Program (BNP) on prevalence of stunting among under-five children in low income setting of Pakistan. The research question that the study aims to answer is:
Is there any change in the prevalence of stunting among under-five children in districts where Benazir Nashonuma Program (BNP) is established compared to districts where BNP is not established?
Districts where BNP is functional, and women and children are receiving the intervention will be compared at baseline and end line with control districts where conventional reproductive care services are given. Prevalence of stunting among under-five children will be compared along with other nutritional and growth status indicators over a period of 4 years.
Read the detailed description
Maternal and child malnutrition is a significant public health challenge, with 40% of under five children being stunted in Pakistan. Stunting is associated with morbidity and mortality with detrimental effects on the physical, social and cognitive development of children. The two key determinants include maternal undernutrition during in-utero and poor infant and child feeding practices in the first two years of life. The opportunity to improve maternal, infant, and child outcomes is provided by the interventions aimed at improving maternal and child nutrition throughout the first 1000 days, known as "window of opportunity". In this study, the investigators aim to assess the effectiveness of the Benazir Nashonuma Programme (BNP) on stunting reduction and related maternal and child health outcomes and to determine the uptake of BNP related services in the intervention districts in all provinces and regions of Pakistan.
The study will achieve the following objectives:
Primary Objective
- To determine the baseline to end-line change in the prevalence of stunting among children 0-59 months of age among low income settings
Secondary Objectives
For under-five children:
To determine the baseline to end-line change in the
- Prevalence of wasting among children 0-59 months of age
- Prevalence of underweight children 0-59 months of age
- Prevalence of Moderate Acute Malnutrition (MAM) among children 0-59 months of age
- Prevalence of Severe Acute Malnutrition (SAM) among children 0-59 months of age
- Prevalence of 0-23 months old children meeting Infant and Young Child Feeding (IYCF) indicators including exclusive breastfeeding, complementary feeding, dietary diversity, minimum acceptable diet and minimum meal frequency.
- Proportion of children 0-59 months of age who received all recommended vaccinations according to the national immunization schedule.
For Women of Reproductive Age (15- 49 years):
To determine the baseline to end-line change in the
- BMI (body mass index) and prevalence of underweight women of reproductive age (WRA)
- Reproductive services uptake by WRA
- Minimum dietary diversity among WRA
- Percentage of households that experienced food insecurity.
A quasi-experimental study with baseline and end-line cross-sectional surveys will be conducted in 18 districts of the four provinces and two administrative areas of Pakistan. The intervention districts includes Shaheed Benazir Abad and Dadu from Sindh, Rajanpur from Punjab, Lasbela and Harnai from Balochistan, Upper Dir and Tank from Khyber Pakhtunkhwa, Diamer from Gilgit Baltistan and Bagh from Azad Jammu and Kashmir. Their control districts are Sangarh, Naushero Feroze, Bahawalnagar, Sibbi, Sherani, Shangla, D. I. Khan, Shigar and Muzaffarbad respectively.
The study will employ a two-stage cluster sampling to enroll children 0-59 months of age and their mothers/caregivers from the 13,200 households (734 per district). The primary (PSUs) and secondary sampling units (SSUs) will include villages and households respectively.
- Conditions
- Stunting, Wasting, Anemia, Nutrient Deficiency
- Being tested
- Benazir Nashonuma Program (BNP)
- Keywords
- Quasi experimental study, Maternal and child nutrition, Stunting, Wasting, Under-five malnutrition, Specialized Nutritious Food (SNF)
- Medical subject headings
- Growth Disorders, Cachexia, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benazir Nashonuma Program (BNP)Combination product
Benazir Nashonuma Program (BNP)
Dietary supplement for pregnant women and lactating mothers during the first six months of lactation:
Maamta is a 75-gram sachet made from peanut butter with 400 kcal of energy
Dietary supplement for children aged 6-23 months:
Wawamum is a lipid-based nutrient supplement consisting of skimmed milk powder, micronutrients, vegetable oil, roasted chickpeas and antioxidants. Wawamum covers the recommended daily dose of most micronutrients and 255 kcal of energy.
Conditional Cash Transfer (CCT):
This includes stipends of PKR 2000 during pregnancy contingent on three antenatal care visits, consuming SNF, attending awareness sessions on health and nutrition, getting two doses of tetanus toxoid and institutional delivery. After delivery PKR 2000/- for boys and 2500/- for girls are paid as incentives conditioned on getting child's birth registered, routine immunization and consumption of SNF by the child from 6-23 months
| Study group | Role | What they receive |
|---|---|---|
| Districts with established and operational BNP implementation | Experimental | The intervention arm consists of nine districts from four provinces and two regions of Pakistan where the Benazir Nashonuma Program (BNP) is operational, providing reproductive and healthcare services to pregnant women and their children under the age of two. Receives: Combination Product: Benazir Nashonuma Program (BNP) |
| Districts without BNP implementation and functionality | No intervention | The control arm comprises of nine districts where Benazir Nashonuma Program (BNP) has not been implemented. These districts are comparable to their respective intervention districts in terms of average maternal BMI and prevalence of stunting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
Measured: 3 years (on study completion)
Secondary outcomes (10)
Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
WRA with a Body Mass Index (BMI) less than 18.5 kg/m2 will be considered underweight
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
Weight-for-height ≤-2 SD of the WHO Child growth standards median
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of food insecurity status at household level
Food Insecurity Experience Scale (FIES) by Food and Agriculture Organization (FAO) is experience-based measures of household or individual food security. It consists of eight questions regarding people's access to adequate food in last 12 months due to lack of money or other resources. Food insecurity is reported as mild, moderate and severe.
Measured: 3 years (on study completion)
Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
Number of antenatal care (ANC) visits done during the preceding pregnancy, leading to a live birth within the last two years.
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of institutional deliveries
Number of women who gave birth at a healthcare facility during the preceding pregnancy, leading to a live birth within the last two years.
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of skilled birth attendance
Number of women whose birth was attended by a skilled health personnel during the preceding pregnancy, leading to a live birth within the last two years.
Measured: 3 years (on study completion)
Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
Consumption of iron folic acid tablets during pregnancy
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
Consumption of at least five out of the ten food groups during the previous day and night (24 hours)
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of infants who were ever breastfed
Number of infants who were breastfed at least once
Measured: 3 years (on study completion)
Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
Number of infants who were fed exclusively with breast milk during the previous day
Measured: 3 years (on study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Dec 2021
- Primary completion20 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- International Food Policy Research Institute, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
- Investigators
- Zulfiqar A Bhutta, PhD, FRC, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025786
- Sponsor's protocol ID
- BNP Quasi Experimental Study
- Status last verified
- Jul 2023
- First submitted
- 16 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Muhammad S, Muzzamil M, Abdul Malik A, Ahmed I, Rizvi A, Sajid M, Ali MU, Maznani I, Soofi SB, Bhutta ZA. Impact of the Benazir Nashonuma Programme on maternal and child health and nutrition in Pakistan: protocol for a prospective cohort study. BMJ Paediatr Open. 2026 Aug 28;10(1):e005047. doi: 10.1136/bmjpo-2026-005047.
PubMed 42665333Muhammad S, Malik AA, Soofi S, Habib A, Umer M, Rizvi A, Ahmed I, Leroy J, Cousens S, Bhutta ZA. Impact assessment of Benazir Nashonuma Programme (BNP) on maternal, child health and nutritional status in Pakistan: a quasi-experimental study protocol. BMJ Open. 2025 Jun 27;15(6):e094565. doi: 10.1136/bmjopen-2024-094565.
PubMed 40578861
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment of Benazir Nashonuma Program (BNP) on Stunting Prevention Among Children 0-59 Months of Age in Pakistan
- ClinicalTrials.gov ID
- NCT06025786
- Acronym / sponsor ID
- BNP Quasi Experimental Study
- Conditions
- Stunting, Wasting, Anemia, Nutrient Deficiency
- Keywords
- Quasi experimental study, Maternal and child nutrition, Stunting, Wasting, Under-five malnutrition, Specialized Nutritious Food (SNF)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,200 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- International Food Policy Research Institute, Bill and Melinda Gates Foundation
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Sep 2023 (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.
The aim of the study is to evaluate the impact of Benazir Nashonuma Program (BNP) on prevalence of stunting among under-five children in low income setting of Pakistan. The research question that the study aims to answer is:
Is there any change in the prevalence of stunting among under-five children in districts where Benazir Nashonuma Program (BNP) is established compared to districts where BNP is not established?
Districts where BNP is functional, and women and children are receiving the intervention will be compared at baseline and end line with control districts where conventional reproductive care services are given. Prevalence of stunting among under-five children will be compared along with other nutritional and growth status indicators over a period of 4 years.
Detailed description
Maternal and child malnutrition is a significant public health challenge, with 40% of under five children being stunted in Pakistan. Stunting is associated with morbidity and mortality with detrimental effects on the physical, social and cognitive development of children. The two key determinants include maternal undernutrition during in-utero and poor infant and child feeding practices in the first two years of life. The opportunity to improve maternal, infant, and child outcomes is provided by the interventions aimed at improving maternal and child nutrition throughout the first 1000 days, known as "window of opportunity". In this study, the investigators aim to assess the effectiveness of the Benazir Nashonuma Programme (BNP) on stunting reduction and related maternal and child health outcomes and to determine the uptake of BNP related services in the intervention districts in all provinces and regions of Pakistan.
The study will achieve the following objectives:
Primary Objective
- To determine the baseline to end-line change in the prevalence of stunting among children 0-59 months of age among low income settings
Secondary Objectives
For under-five children:
To determine the baseline to end-line change in the
- Prevalence of wasting among children 0-59 months of age
- Prevalence of underweight children 0-59 months of age
- Prevalence of Moderate Acute Malnutrition (MAM) among children 0-59 months of age
- Prevalence of Severe Acute Malnutrition (SAM) among children 0-59 months of age
- Prevalence of 0-23 months old children meeting Infant and Young Child Feeding (IYCF) indicators including exclusive breastfeeding, complementary feeding, dietary diversity, minimum acceptable diet and minimum meal frequency.
- Proportion of children 0-59 months of age who received all recommended vaccinations according to the national immunization schedule.
For Women of Reproductive Age (15- 49 years):
To determine the baseline to end-line change in the
- BMI (body mass index) and prevalence of underweight women of reproductive age (WRA)
- Reproductive services uptake by WRA
- Minimum dietary diversity among WRA
- Percentage of households that experienced food insecurity.
A quasi-experimental study with baseline and end-line cross-sectional surveys will be conducted in 18 districts of the four provinces and two administrative areas of Pakistan. The intervention districts includes Shaheed Benazir Abad and Dadu from Sindh, Rajanpur from Punjab, Lasbela and Harnai from Balochistan, Upper Dir and Tank from Khyber Pakhtunkhwa, Diamer from Gilgit Baltistan and Bagh from Azad Jammu and Kashmir. Their control districts are Sangarh, Naushero Feroze, Bahawalnagar, Sibbi, Sherani, Shangla, D. I. Khan, Shigar and Muzaffarbad respectively.
The study will employ a two-stage cluster sampling to enroll children 0-59 months of age and their mothers/caregivers from the 13,200 households (734 per district). The primary (PSUs) and secondary sampling units (SSUs) will include villages and households respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Districts with established and operational BNP implementation | Experimental | Combination Product: Benazir Nashonuma Program (BNP)The intervention arm consists of nine districts from four provinces and two regions of Pakistan where the Benazir Nashonuma Program (BNP) is operational, providing reproductive and healthcare services to pregnant women and their children under the age of two. |
| Districts without BNP implementation and functionality | No intervention | –The control arm comprises of nine districts where Benazir Nashonuma Program (BNP) has not been implemented. These districts are comparable to their respective intervention districts in terms of average maternal BMI and prevalence of stunting. |
Who may qualify
- Ages
- 1 day to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Mother of the child who is not a woman of reproductive age, i.e., less than 15 years or greater than 49 years
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 |
|---|---|---|
| Benazir Nashonuma Program (BNP)Benazir Nashonuma Program (BNP) Dietary supplement for pregnant women and lactating mothers during the first six months of lactation: Maamta is a 75-gram sachet made from peanut butter with 400 kcal of energy Dietary supplement for children aged 6-23 months: Wawamum is a lipid-based nutrient supplement consisting of skimmed milk powder, micronutrients, vegetable oil, roasted chickpeas and antioxidants. Wawamum covers the recommended daily dose of most micronutrients and 255 kcal of energy. Conditional Cash Transfer (CCT): This includes stipends of PKR 2000 during pregnancy contingent on three antenatal care visits, consuming SNF, attending awareness sessions on health and nutrition, getting two doses of tetanus toxoid and institutional delivery. After delivery PKR 2000/- for boys and 2500/- for girls are paid as incentives conditioned on getting child's birth registered, routine immunization and consumption of SNF by the child from 6-23 months | Combination product | Districts with established and operational BNP implementation |
Primary outcome
Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
Time frame: 3 years (on study completion)
Height-for-age ≤-2 SD of the WHO Child growth standards median
10 secondary outcomes
Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of food insecurity status at household level
Time frame: 3 years (on study completion)
Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of institutional deliveries
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of skilled birth attendance
Time frame: 3 years (on study completion)
Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of infants who were ever breastfed
Time frame: 3 years (on study completion)
Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
Time frame: 3 years (on study completion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 42665333Muhammad S, Muzzamil M, Abdul Malik A, Ahmed I, Rizvi A, Sajid M, Ali MU, Maznani I, Soofi SB, Bhutta ZA. Impact of the Benazir Nashonuma Programme on maternal and child health and nutrition in Pakistan: protocol for a prospective cohort study. BMJ Paediatr Open. 2026 Aug 28;10(1):e005047. doi: 10.1136/bmjpo-2026-005047.
- Derived from this study: PubMed 40578861Muhammad S, Malik AA, Soofi S, Habib A, Umer M, Rizvi A, Ahmed I, Leroy J, Cousens S, Bhutta ZA. Impact assessment of Benazir Nashonuma Programme (BNP) on maternal, child health and nutritional status in Pakistan: a quasi-experimental study protocol. BMJ Open. 2025 Jun 27;15(6):e094565. doi: 10.1136/bmjopen-2024-094565.
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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.
Zulfiqar A Bhutta, PhD, FRC principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benazir Nashonuma Program (BNP) in people with Stunting and Wasting, 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 0 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sajid Bashir Soofi, MD, CPSP (+923002769398, sajid.soofi@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline to end-line change in the prevalence of stunting among children 0-59 months of age (time frame: 3 years (on study completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06025786, which also lists 2 linked publications.
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 11 Sep 2023.