Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836961
Status:
RECRUITING
Last Update Posted:
2023-05-01
First Post:
2023-03-13
Brief Title:
Impact of Benazir Nashonuma Program BNP on Maternal and Child Nutritional Status
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Evaluating Effectiveness of Benazir Nashonuma Program BNP on Maternal and Infant Outcomes A Non-randomized Intervention Study in Sindh and Punjab
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 402 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None