Aga Khan Office
Dadu, Sindh, Pakistan
Location status: Recruiting
NCT Number: NCT05836961
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.
Interested in participating?
Request Info18 year–49 year
Female
Interventional
Not applicable
Dadu, Sindh, Pakistan
Location status: Recruiting
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:
The secondary objectives related to maternal outcomes are to assess the impact of intervention on:
The secondary objectives related to newborn and infant outcomes are to assess the impact of the intervention on:
Other objectives include following:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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
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
Time frame: At 6 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time frame: At 12 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time frame: At 6 and 12 months of age
Weight-for-height ≤-2 SD of the WHO Child growth standards median.
Time frame: 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
Time frame: 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
Time frame: At delivery
Attending at least 8 ANC consultations in a health facility/clinic
Time frame: At delivery
Having delivered in a health facility
Time frame: At delivery
Birth attended by a skilled health personnel
Time frame: 3 months after delivery
Receiving a postnatal health check while in a facility or at home within 6-weeks of postnatal period
Time frame: At 9th month of pregnancy
Mean nutrient intake of energy in kilocalories using 24-hour recall.
Time frame: At 12 months of age
Number of infants who were breastfed at least once
Time frame: At 12 months of age
Number of infants who were put to the breast within one hour of birth
Time frame: At 12 months of age
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
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
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
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 6 months after delivery
Utilization of supplementation (SNF) by the woman during pregnancy and first 6 months of lactation after delivery
Time frame: At 12 months of age
Utilization of supplementation (SNF) by the infant from 6-23 months of age
Contact information is provided by the study sponsor or research team.
Dr Asma Abdul Malik
CONTACT
Dr Sajid Bashir Soofi
CONTACT
Aga Khan University
Other
Evaluating Effectiveness of Benazir Nashonuma Program (BNP) on Maternal and Infant Outcomes: A Non-randomized Intervention Study in Sindh and Punjab
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