Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status

Sponsor
Aga Khan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05836961
Collaborator
International Food Policy Research Institute (Other), Bill and Melinda Gates Foundation (Other), London School of Hygiene and Tropical Medicine (Other)
5,500
1
2
43
128

Study Details

Study Description

Brief 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. The study aims to answer if:

  1. 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.

  2. 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Benazir Nashonuma Program (BNP)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
5500 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: BNP enrolled

Pregnant women in their first or second trimester who have been enrolled in BNP

Other: 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

No Intervention: BNP non-enrolled

Pregnant women in their first or second trimester who are not enrolled in BNP

Outcome Measures

Primary Outcome Measures

  1. Prevalence of low birthweight [Within 48-hours of delivery]

    Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery

  2. Prevalence of stunting [At 6 months of age]

    Height-for-age ≤-2 SD of the WHO Child growth standards median

  3. Prevalence of stunting [At 12 months of age]

    Height-for-age ≤-2 SD of the WHO Child growth standards median

Secondary Outcome Measures

  1. Prevalence of wasting [At 6 and 12 months of age]

    Weight-for-height ≤-2 SD of the WHO Child growth standards median.

  2. Prevalence of Iron deficiency anemia in pregnant women [At 9th month on pregnancy]

    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

  3. Prevalence of Iron deficiency anemia in infants [2 point times: At 6 and 12 months of age]

    Hemoglobin concentration of less than 11.0 g/dl and ferritin levels of less than 15 micrograms/L

  4. Number of antenatal care (ANC) visits during pregnancy [At delivery]

    Attending at least 8 ANC consultations in a health facility/clinic

  5. Number of women who had an Institutional delivery [At delivery]

    Having delivered in a health facility

  6. Number of women who had Skilled birth attendance [At delivery]

    Birth attended by a skilled health personnel

  7. Number of women who had Postnatal care (PNC) check ups [3 months after delivery]

    Receiving a postnatal health check while in a facility or at home within 6-weeks of postnatal period

  8. Mean nutrient intake of energy in kilocalories of the pregnant woman [At 9th month of pregnancy]

    Mean nutrient intake of energy in kilocalories using 24-hour recall.

  9. Prevalence of infants who were ever breastfed [At 12 months of age]

    Number of infants who were breastfed at least once

  10. Prevalence of infants who had early initiation of breastfeeding [At 12 months of age]

    Number of infants who were put to the breast within one hour of birth

  11. Prevalence of infants who were exclusively breastfed [At 12 months of age]

    Number of of infants aged 0-5 months who were fed exclusively with breast milk during the previous day

  12. Prevalence of infants who consumed a minimum acceptable diet [At 12 months of age]

    Number of infants 6-12 months of age who consumed a minimum acceptable diet during the previous day

  13. Prevalence of infants with minimum dietary diversity [At 12 months of age]

    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

  14. Mean scores of Neurodevelopmental outcomes of the infant [At 12 months of age]

    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

  15. Number of women consuming specialized nutritious food (SNF) [At 6 months after delivery]

    Utilization of supplementation (SNF) by the woman during pregnancy and first 6 months of lactation after delivery

  16. Number of infants consuming specialized nutritious food (SNF) [At 12 months of age]

    Utilization of supplementation (SNF) by the infant from 6-23 months of age

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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).

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aga Khan Office Dadu Sindh Pakistan

Sponsors and Collaborators

  • Aga Khan University
  • International Food Policy Research Institute
  • Bill and Melinda Gates Foundation
  • London School of Hygiene and Tropical Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr Zulfiqar Ahmed Bhutta, Distinguished University Professor and Founding Director of the Institute for Global Health and Development and the Centre of Excellence in Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier:
NCT05836961
Other Study ID Numbers:
  • BNP Study
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Dr Zulfiqar Ahmed Bhutta, Distinguished University Professor and Founding Director of the Institute for Global Health and Development and the Centre of Excellence in Women and Child Health, Aga Khan University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 1, 2023