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

NCT ID: NCT05836961

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-09-30

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.

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).

Conditions

Low Birthweight; Stunting; Wasting; Malnutrition, Child; Iron Deficiency Anemia; Dietary Habits

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BNP enrolled

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

Group Type: EXPERIMENTAL

Benazir Nashonuma Program (BNP)

Intervention Type: OTHER

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

BNP non-enrolled

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Food Policy Research Institute

OTHER

Sponsor Role: collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aga Khan Office

Dadu, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr Sajid Bashir Soofi

Role: CONTACT

sajid.soofi@aku.edu

+923002769398

Dr Asma Abdul Malik

Role: CONTACT

asma.qureshi@aku.edu

+923311388051

Facility Contacts

Asma Abdul Malik, MSc Epidemiology

Role: primary

asma.qureshi@aku.edu

00923311388051

Other Identifiers

BNP Study

Identifier Type: -

Identifier Source: org_study_id