Impact of Benazir Nashonuma Program (BNP) on Maternal and Child Nutritional Status
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorAga Khan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Benazir Nashonuma Program (BNP)
Other interventionDietary 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
Treatment groups
5,500 Participants
are divided into 2 treatment groupsGroup A: BNP enrolledExperimental treatment 1 intervention
Group B: BNP non-enrolledNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Prevalence of low birthweight
Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery
Time frame
Within 48-hours of delivery2
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time frame
At 6 months of age3
Prevalence of stunting
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time frame
At 12 months of ageSecondary outcomes
1
Prevalence of wasting
Weight-for-height ≤-2 SD of the WHO Child growth standards median.
Time frame
At 6 and 12 months of age2
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
Time frame
At 9th month on pregnancy3
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
Time frame
2 point times: At 6 and 12 months of age4
Number of antenatal care (ANC) visits during pregnancy
Attending at least 8 ANC consultations in a health facility/clinic
Time frame
At deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Aga Khan University
Lead sponsor
International Food Policy Research Institute
Collaborator
Bill and Melinda Gates Foundation
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
Source ClinicalTrials.gov