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

Primary Purpose

Low Birthweight, Stunting, Wasting

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Benazir Nashonuma Program (BNP)
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Low Birthweight focused on measuring Intervention study, Maternal and child nutrition, Benazir Nashonuma Program (BNP), Low birthweight, Stunting

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Aga Khan OfficeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

BNP enrolled

BNP non-enrolled

Arm Description

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

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

Outcomes

Primary Outcome Measures

Prevalence of low birthweight
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median

Secondary Outcome Measures

Prevalence of wasting
Weight-for-height ≤-2 SD of the WHO Child growth standards median.
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
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
Number of antenatal care (ANC) visits during pregnancy
Attending at least 8 ANC consultations in a health facility/clinic
Number of women who had an Institutional delivery
Having delivered in a health facility
Number of women who had Skilled birth attendance
Birth attended by a skilled health personnel
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
Mean nutrient intake of energy in kilocalories of the pregnant woman
Mean nutrient intake of energy in kilocalories using 24-hour recall.
Prevalence of infants who were ever breastfed
Number of infants who were breastfed at least once
Prevalence of infants who had early initiation of breastfeeding
Number of infants who were put to the breast within one hour of birth
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
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
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
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
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
Number of infants consuming specialized nutritious food (SNF)
Utilization of supplementation (SNF) by the infant from 6-23 months of age

Full Information

First Posted
March 13, 2023
Last Updated
April 28, 2023
Sponsor
Aga Khan University
Collaborators
International Food Policy Research Institute, Bill and Melinda Gates Foundation, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05836961
Brief Title
Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status
Official Title
Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
International Food Policy Research Institute, Bill and Melinda Gates Foundation, London School of Hygiene and Tropical Medicine

4. Oversight

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

5. 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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BNP enrolled
Arm Type
Experimental
Arm Description
Pregnant women in their first or second trimester who have been enrolled in BNP
Arm Title
BNP non-enrolled
Arm Type
No Intervention
Arm Description
Pregnant women in their first or second trimester who are not enrolled in BNP
Intervention Type
Other
Intervention Name(s)
Benazir Nashonuma Program (BNP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Prevalence of low birthweight
Description
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Time Frame
Within 48-hours of delivery
Title
Prevalence of stunting
Description
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time Frame
At 6 months of age
Title
Prevalence of stunting
Description
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time Frame
At 12 months of age
Secondary Outcome Measure Information:
Title
Prevalence of wasting
Description
Weight-for-height ≤-2 SD of the WHO Child growth standards median.
Time Frame
At 6 and 12 months of age
Title
Prevalence of Iron deficiency anemia in pregnant women
Description
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
Time Frame
At 9th month on pregnancy
Title
Prevalence of Iron deficiency anemia in infants
Description
Hemoglobin concentration of less than 11.0 g/dl and ferritin levels of less than 15 micrograms/L
Time Frame
2 point times: At 6 and 12 months of age
Title
Number of antenatal care (ANC) visits during pregnancy
Description
Attending at least 8 ANC consultations in a health facility/clinic
Time Frame
At delivery
Title
Number of women who had an Institutional delivery
Description
Having delivered in a health facility
Time Frame
At delivery
Title
Number of women who had Skilled birth attendance
Description
Birth attended by a skilled health personnel
Time Frame
At delivery
Title
Number of women who had Postnatal care (PNC) check ups
Description
Receiving a postnatal health check while in a facility or at home within 6-weeks of postnatal period
Time Frame
3 months after delivery
Title
Mean nutrient intake of energy in kilocalories of the pregnant woman
Description
Mean nutrient intake of energy in kilocalories using 24-hour recall.
Time Frame
At 9th month of pregnancy
Title
Prevalence of infants who were ever breastfed
Description
Number of infants who were breastfed at least once
Time Frame
At 12 months of age
Title
Prevalence of infants who had early initiation of breastfeeding
Description
Number of infants who were put to the breast within one hour of birth
Time Frame
At 12 months of age
Title
Prevalence of infants who were exclusively breastfed
Description
Number of of infants aged 0-5 months who were fed exclusively with breast milk during the previous day
Time Frame
At 12 months of age
Title
Prevalence of infants who consumed a minimum acceptable diet
Description
Number of infants 6-12 months of age who consumed a minimum acceptable diet during the previous day
Time Frame
At 12 months of age
Title
Prevalence of infants with minimum dietary diversity
Description
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
Time Frame
At 12 months of age
Title
Mean scores of Neurodevelopmental outcomes of the infant
Description
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
Time Frame
At 12 months of age
Title
Number of women consuming specialized nutritious food (SNF)
Description
Utilization of supplementation (SNF) by the woman during pregnancy and first 6 months of lactation after delivery
Time Frame
At 6 months after delivery
Title
Number of infants consuming specialized nutritious food (SNF)
Description
Utilization of supplementation (SNF) by the infant from 6-23 months of age
Time Frame
At 12 months of age

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Sajid Bashir Soofi
Phone
+923002769398
Email
sajid.soofi@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Asma Abdul Malik
Phone
+923311388051
Email
asma.qureshi@aku.edu
Facility Information:
Facility Name
Aga Khan Office
City
Dadu
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asma Abdul Malik, MSc Epidemiology
Phone
00923311388051
Email
asma.qureshi@aku.edu

12. IPD Sharing Statement

Learn more about this trial

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

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