Clinical trial NCT05836961: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: International Food Policy Research Institute
name: Bill and Melinda Gates Foundation
name: London School of Hygiene and Tropical Medicine
First posted: 2023-05-01
Enrollment: 5500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Prevalence of low birthweight
timeFrame: Within 48-hours of delivery
measure: Prevalence of stunting
timeFrame: At 6 months of age
measure: Prevalence of stunting
timeFrame: At 12 months of age
Secondary outcomes:
measure: Prevalence of wasting
timeFrame: At 6 and 12 months of age
measure: Prevalence of Iron deficiency anemia in pregnant women
timeFrame: At 9th month on pregnancy
measure: Prevalence of Iron deficiency anemia in infants
timeFrame: 2 point times: At 6 and 12 months of age
measure: Number of antenatal care (ANC) visits during pregnancy
timeFrame: At delivery
measure: Number of women who had an Institutional delivery
timeFrame: At delivery
measure: Number of women who had Skilled birth attendance
timeFrame: At delivery
measure: Number of women who had Postnatal care (PNC) check ups
timeFrame: 3 months after delivery
measure: Mean nutrient intake of energy in kilocalories of the pregnant woman
timeFrame: At 9th month of pregnancy
measure: Prevalence of infants who were ever breastfed
timeFrame: At 12 months of age
measure: Prevalence of infants who had early initiation of breastfeeding
timeFrame: At 12 months of age
measure: Prevalence of infants who were exclusively breastfed
timeFrame: At 12 months of age
measure: Prevalence of infants who consumed a minimum acceptable diet
timeFrame: At 12 months of age
measure: Prevalence of infants with minimum dietary diversity
timeFrame: At 12 months of age
measure: Mean scores of Neurodevelopmental outcomes of the infant
timeFrame: At 12 months of age
measure: Number of women consuming specialized nutritious food (SNF)
timeFrame: At 6 months after delivery
measure: Number of infants consuming specialized nutritious food (SNF)
timeFrame: At 12 months of age
Other outcomes:
Locations:
city: Dadu
country: Pakistan
facility: Aga Khan Office
state: Sindh
Study officials:
References: