Low BirthweightNCT05836961
Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status
A study testing Benazir Nashonuma Program (BNP) in people with Low Birthweight and Stunting, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Birthweight, Stunting, Wasting
- 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
- 5,500 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to Sep 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Intervention arm: All pregnant women in their first or second trimester, who are enrolled in Benazir Nashonuma Program (BNP).
- Non-intervention arm: All pregnant women in their first or second trimester, who are not enrolled in Benazir Nashonuma Program (BNP).
Who cannot join
- Women who intend to migrate or relocate for more than 3 months during the study period will be excluded from the study.
- Women in the non intervention group who are consuming specialized nutritious food (SNF) from any source at the time of enrollment will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan Office
Dadu, Sindh
Asma Abdul Malik, MSc Epidemiology, 00923311388051, asma.qureshi@aku.edu
About this study
Official title: Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
The purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if:
- Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population.
- Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population.
Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
Read the detailed description
Malnutrition in Pakistan is a major and pervasive public health issue. Every four under five children in our country are reported to be stunted, with a mighty prevalence of 40.2% stunting as reported in the National Nutritional Survey of Pakistan 2018. Pakistan also shares one of the highest burden of low birthweight (LBW) where 19% babies in urban and 32% in rural are born with weight <2500 grams. LBW babies have a higher risk of death compared to full term babies and contributes to 60-80% of all neonatal deaths.
The first 1000 days of life, the time from conception to 2 years of age, is a critical period, providing a window of opportunity for interventions to improve maternal and child nutrition and health outcomes including stunting and other nutritional markers. Availability and access to primary healthcare and nutrition services during pregnancy and the first two years of life can help prevent undernutrition and reduce infections in early life, helping reduce maternal and infant mortality, and preventing the lifelong and intergenerational consequences of malnutrition. Evidence-based nutrition interventions, especially the combination of BEP and small quantity lipid nutrient supplements have been shown to be effective in improving birth outcomes and reducing child stunting.
BNP is a health and nutrition CCT programme, with the aim to address stunting in children under 23 months of age. The CCT and Specialized Nutritious Food (SNF) are provided to Benazir Income Support Programme (BISP) participating women during pregnancy and lactation up to 6 months and to children aged 6-23 months contingent on their participation in and adherence to BNP interventions. In addition to the programme components, the pre-existing standard of care interventions including antenatal and postnatal care, childhood immunizations, growth monitoring and behavior change communication (BCC) activities, i.e., awareness sessions on health, nutrition and hygiene.
The primary study objectives are to assess the impact of intervention (BNP) on:
- Proportion of babies born with low birthweight.
- Prevalence of stunting among infants at 6 and 12 months of age
The secondary objectives related to maternal outcomes are to assess the impact of intervention on:
- Dietary diversity of women
- Mean nutrient intake including energy in kilo calories.
- Prevalence of iron deficiency anemia among lactating women.
- Proportion of pregnant women using reproductive health services.
The secondary objectives related to newborn and infant outcomes are to assess the impact of the intervention on:
- Prevalence of wasting among infants at 6 and 12 months of age.
- Incidence of anemia among infants at 6- and 12-months of age
- Infant and child feeding practices among infants at 6 and 12 months of age.
- Neurodevelopmental outcomes (cognitive, language and motor development) using Bayley Scales of Infant and Toddler Development (BSID-IV) at 6 months, and 12 months of age among children.
Other objectives include following:
- To measure receipt and utilization of BEP supplementation among pregnant and lactating women enrolled in BNP.
- To measure receipt and utilization on BEP supplementation among children under 12 months of age enrolled in BNP
- Household food insecurity status (using the Food Insecurity Experience Scale).
- Conditions
- Low Birthweight, Stunting, Wasting, Malnutrition, Child, Iron Deficiency Anemia, Dietary Habits
- Being tested
- Benazir Nashonuma Program (BNP)
- Keywords
- Intervention study, Maternal and child nutrition, Benazir Nashonuma Program (BNP), Low birthweight, Stunting
- Medical subject headings
- Growth Disorders, Cachexia, Child Nutrition Disorders, Anemia, Iron-Deficiency, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benazir Nashonuma Program (BNP)Other
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 (1/4 of daily energy requirements for children in this age range)
Conditional Cash Transfers (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 |
|---|---|---|
| BNP enrolled | Experimental | Pregnant women in their first or second trimester who have been enrolled in BNP Receives: Other: Benazir Nashonuma Program (BNP) |
| BNP non-enrolled | No intervention | Pregnant women in their first or second trimester who are not enrolled in BNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of low birthweight
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Measured: Within 48-hours of delivery
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median
Measured: At 6 months of age
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median
Measured: At 12 months of age
Secondary outcomes (16)
Prevalence of wasting
Weight-for-height ≤-2 SD of the WHO Child growth standards median.
Measured: At 6 and 12 months of age
Prevalence of Iron deficiency anemia in pregnant women
Hemoglobin levels below 11 g/dl, serum ferritin less than or equal to 30 ng/ml, mean corpuscular volume MCV below 95 fl will be considered diagnostic of iron deficiency anemia
Measured: At 9th month on pregnancy
Prevalence of Iron deficiency anemia in infants
Hemoglobin concentration of less than 11.0 g/dl and ferritin levels of less than 15 micrograms/L
Measured: 2 point times: At 6 and 12 months of age
Number of antenatal care (ANC) visits during pregnancy
Attending at least 8 ANC consultations in a health facility/clinic
Measured: At delivery
Number of women who had an Institutional delivery
Having delivered in a health facility
Measured: At delivery
Number of women who had Skilled birth attendance
Birth attended by a skilled health personnel
Measured: At delivery
Number of women who had Postnatal care (PNC) check ups
Receiving a postnatal health check while in a facility or at home within 6-weeks of postnatal period
Measured: 3 months after delivery
Mean nutrient intake of energy in kilocalories of the pregnant woman
Mean nutrient intake of energy in kilocalories using 24-hour recall.
Measured: At 9th month of pregnancy
Prevalence of infants who were ever breastfed
Number of infants who were breastfed at least once
Measured: At 12 months of age
Prevalence of infants who had early initiation of breastfeeding
Number of infants who were put to the breast within one hour of birth
Measured: At 12 months of age
Prevalence of infants who were exclusively breastfed
Number of of infants aged 0-5 months who were fed exclusively with breast milk during the previous day
Measured: At 12 months of age
Prevalence of infants who consumed a minimum acceptable diet
Number of infants 6-12 months of age who consumed a minimum acceptable diet during the previous day
Measured: At 12 months of age
Prevalence of infants with minimum dietary diversity
Number of infants 6-12 months of age who consumed foods and beverages from at least four out of eight defined food groups during the previous day
Measured: At 12 months of age
Mean scores of Neurodevelopmental outcomes of the infant
Neurodevelopmental outcomes of the children will be assessed using Bayley Scales of Infant and Toddler Development (BSID-IV). Mean scores will be reported for cognitive, language and motor development of the infant using Bayley's scales. Higher scores in the Bayley Scales indicate better outcomes
Measured: At 12 months of age
Number of women consuming specialized nutritious food (SNF)
Utilization of supplementation (SNF) by the woman during pregnancy and first 6 months of lactation after delivery
Measured: At 6 months after delivery
Number of infants consuming specialized nutritious food (SNF)
Utilization of supplementation (SNF) by the infant from 6-23 months of age
Measured: At 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Feb 2023
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low BirthweightStudies 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
- 5,500 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, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Dr Zulfiqar Ahmed Bhutta, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836961
- Sponsor's protocol ID
- BNP Study
- Status last verified
- Jan 2023
- First submitted
- 13 Mar 2023
- Last updated
- 1 May 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 42665333
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
- ClinicalTrials.gov ID
- NCT05836961
- Acronym / sponsor ID
- BNP Study
- Conditions
- Low Birthweight, Stunting, Wasting, Malnutrition, Child, Iron Deficiency Anemia, Dietary Habits
- Keywords
- Intervention study, Maternal and child nutrition, Benazir Nashonuma Program (BNP), Low birthweight, Stunting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- International Food Policy Research Institute, Bill and Melinda Gates Foundation, London School of Hygiene and Tropical Medicine
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 May 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 purpose of this study is to evaluate the impact of Benazir Nashonuma Program (BNP) which includes specialized nutritious food (SNF) augmented with specific reproductive health interventions during pregnancy on proportion of low birthweight babies and stunting among children, in low income setting of Pakistan. The study aims to answer if:
- Utilization of Benazir Nashonuma Program (BNP) among pregnant women is effective in reducing the proportion of low birthweight babies, compared to pregnant women who are not utilizing the program, among low income setting population.
- Utilization of Benazir Nashonuma Program (BNP) is effective in reducing the proportion of stunting among children, compared to those not utilizing the program, among low income setting population.
Participants who are enrolled in the Benazir Nashonuma Program (receiving intervention) and those who are not enrolled (not receiving intervention) will be followed throughout pregnancy till delivery. After delivery mother-baby dyad will be followed for a period of 12 months. Compliance of supplementation will be measured, and outcomes (low birthweight and stunting) observed throughout the follow up.
Detailed description
Malnutrition in Pakistan is a major and pervasive public health issue. Every four under five children in our country are reported to be stunted, with a mighty prevalence of 40.2% stunting as reported in the National Nutritional Survey of Pakistan 2018. Pakistan also shares one of the highest burden of low birthweight (LBW) where 19% babies in urban and 32% in rural are born with weight <2500 grams. LBW babies have a higher risk of death compared to full term babies and contributes to 60-80% of all neonatal deaths.
The first 1000 days of life, the time from conception to 2 years of age, is a critical period, providing a window of opportunity for interventions to improve maternal and child nutrition and health outcomes including stunting and other nutritional markers. Availability and access to primary healthcare and nutrition services during pregnancy and the first two years of life can help prevent undernutrition and reduce infections in early life, helping reduce maternal and infant mortality, and preventing the lifelong and intergenerational consequences of malnutrition. Evidence-based nutrition interventions, especially the combination of BEP and small quantity lipid nutrient supplements have been shown to be effective in improving birth outcomes and reducing child stunting.
BNP is a health and nutrition CCT programme, with the aim to address stunting in children under 23 months of age. The CCT and Specialized Nutritious Food (SNF) are provided to Benazir Income Support Programme (BISP) participating women during pregnancy and lactation up to 6 months and to children aged 6-23 months contingent on their participation in and adherence to BNP interventions. In addition to the programme components, the pre-existing standard of care interventions including antenatal and postnatal care, childhood immunizations, growth monitoring and behavior change communication (BCC) activities, i.e., awareness sessions on health, nutrition and hygiene.
The primary study objectives are to assess the impact of intervention (BNP) on:
- Proportion of babies born with low birthweight.
- Prevalence of stunting among infants at 6 and 12 months of age
The secondary objectives related to maternal outcomes are to assess the impact of intervention on:
- Dietary diversity of women
- Mean nutrient intake including energy in kilo calories.
- Prevalence of iron deficiency anemia among lactating women.
- Proportion of pregnant women using reproductive health services.
The secondary objectives related to newborn and infant outcomes are to assess the impact of the intervention on:
- Prevalence of wasting among infants at 6 and 12 months of age.
- Incidence of anemia among infants at 6- and 12-months of age
- Infant and child feeding practices among infants at 6 and 12 months of age.
- Neurodevelopmental outcomes (cognitive, language and motor development) using Bayley Scales of Infant and Toddler Development (BSID-IV) at 6 months, and 12 months of age among children.
Other objectives include following:
- To measure receipt and utilization of BEP supplementation among pregnant and lactating women enrolled in BNP.
- To measure receipt and utilization on BEP supplementation among children under 12 months of age enrolled in BNP
- Household food insecurity status (using the Food Insecurity Experience Scale).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BNP enrolled | Experimental | Other: Benazir Nashonuma Program (BNP)Pregnant women in their first or second trimester who have been enrolled in BNP |
| BNP non-enrolled | No intervention | –Pregnant women in their first or second trimester who are not enrolled in BNP |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Intervention arm: All pregnant women in their first or second trimester, who are enrolled in Benazir Nashonuma Program (BNP).
- Non-intervention arm: All pregnant women in their first or second trimester, who are not enrolled in Benazir Nashonuma Program (BNP).
Key exclusion criteria (2 listed)
- Women who intend to migrate or relocate for more than 3 months during the study period will be excluded from the study.
- Women in the non intervention group who are consuming specialized nutritious food (SNF) from any source at the time of enrollment will be excluded from the study.
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)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 (1/4 of daily energy requirements for children in this age range) Conditional Cash Transfers (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 | Other | BNP enrolled |
Primary outcome
Prevalence of low birthweight
Time frame: Within 48-hours of delivery
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Prevalence of stunting
Time frame: At 6 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
Prevalence of stunting
Time frame: At 12 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
16 secondary outcomes
Prevalence of wasting
Time frame: At 6 and 12 months of age
Prevalence of Iron deficiency anemia in pregnant women
Time frame: At 9th month on pregnancy
Prevalence of Iron deficiency anemia in infants
Time frame: 2 point times: At 6 and 12 months of age
Number of antenatal care (ANC) visits during pregnancy
Time frame: At delivery
Number of women who had an Institutional delivery
Time frame: At delivery
Number of women who had Skilled birth attendance
Time frame: At delivery
Number of women who had Postnatal care (PNC) check ups
Time frame: 3 months after delivery
Mean nutrient intake of energy in kilocalories of the pregnant woman
Time frame: At 9th month of pregnancy
Prevalence of infants who were ever breastfed
Time frame: At 12 months of age
Prevalence of infants who had early initiation of breastfeeding
Time frame: At 12 months of age
Prevalence of infants who were exclusively breastfed
Time frame: At 12 months of age
Prevalence of infants who consumed a minimum acceptable diet
Time frame: At 12 months of age
Prevalence of infants with minimum dietary diversity
Time frame: At 12 months of age
Mean scores of Neurodevelopmental outcomes of the infant
Time frame: At 12 months of age
Number of women consuming specialized nutritious food (SNF)
Time frame: At 6 months after delivery
Number of infants consuming specialized nutritious food (SNF)
Time frame: At 12 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 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.
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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.
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 Low Birthweight and Stunting, 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 2 inclusion and 2 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 1 May 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 Dr Sajid Bashir Soofi (+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?
Prevalence of low birthweight (time frame: Within 48-hours of delivery). The study lists 3 primary outcomes in all. 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 NCT05836961, which also lists 1 linked publication.
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 1 May 2023.