Clinical trial NCT06025786: Impact Evaluation of Benazir Nashonuma Program (BNP) on Stunting Among Under-five Children
Official title: Impact Assessment of Benazir Nashonuma Program (BNP) on Stunting Prevention Among Children 0-59 Months of Age in Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stunting
Wasting
Anemia
Nutrient Deficiency
Keywords: Quasi experimental study
Maternal and child nutrition
Stunting
Wasting
Under-five malnutrition
Specialized Nutritious Food (SNF)
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: International Food Policy Research Institute
name: Bill and Melinda Gates Foundation
First posted: 2023-09-06
Enrollment: 13200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the impact of Benazir Nashonuma Program (BNP) on prevalence of stunting among under-five children in low income setting of Pakistan. The research question that the study aims to answer is:

Is there any change in the prevalence of stunting among under-five children in districts where Benazir Nashonuma Program (BNP) is established compared to districts where BNP is not established?

Districts where BNP is functional, and women and children are receiving the intervention will be compared at baseline and end line with control districts where conventional reproductive care services are given. Prevalence of stunting among under-five children will be compared along with other nutritional and growth status indicators over a period of 4 years.

Detailed description: Maternal and child malnutrition is a significant public health challenge, with 40% of under five children being stunted in Pakistan. Stunting is associated with morbidity and mortality with detrimental effects on the physical, social and cognitive development of children. The two key determinants include maternal undernutrition during in-utero and poor infant and child feeding practices in the first two years of life. The opportunity to improve maternal, infant, and child outcomes is provided by the interventions aimed at improving maternal and child nutrition throughout the first 1000 days, known as "window of opportunity". In this study, the investigators aim to assess the effectiveness of the Benazir Nashonuma Programme (BNP) on stunting reduction and related maternal and child health outcomes and to determine the uptake of BNP related services in the intervention districts in all provinces and regions of Pakistan.

The study will achieve the following objectives:

Primary Objective

• To determine the baseline to end-line change in the prevalence of stunting among children 0-59 months of age among low income settings

Secondary Objectives

For under-five children:

To determine the baseline to end-line change in the

* Prevalence of wasting among children 0-59 months of age
* Prevalence of underweight children 0-59 months of age
* Prevalence of Moderate Acute Malnutrition (MAM) among children 0-59 months of age
* Prevalence of Severe Acute Malnutrition (SAM) among children 0-59 months of age
* Prevalence of 0-23 months old children meeting Infant and Young Child Feeding (IYCF) indicators including exclusive breastfeeding, complementary feeding, dietary diversity, minimum acceptable diet and minimum meal frequency.
* Proportion of children 0-59 months of age who received all recommended vaccinations according to the national immunization schedule.

For Women of Reproductive Age (15- 49 years):

To determine the baseline to end-line change in the

* BMI (body mass index) and prevalence of underweight women of reproductive age (WRA)
* Reproductive services uptake by WRA
* Minimum dietary diversity among WRA
* Percentage of households that experienced food insecurity.

A quasi-experimental study with baseline and end-line cross-sectional surveys will be conducted in 18 districts of the four provinces and two administrative areas of Pakistan. The intervention districts includes Shaheed Benazir Abad and Dadu from Sindh, Rajanpur from Punjab, Lasbela and Harnai from Balochistan, Upper Dir and Tank from Khyber Pakhtunkhwa, Diamer from Gilgit Baltistan and Bagh from Azad Jammu and Kashmir. Their control districts are Sangarh, Naushero Feroze, Bahawalnagar, Sibbi, Sherani, Shangla, D. I. Khan, Shigar and Muzaffarbad respectively.

The study will employ a two-stage cluster sampling to enroll children 0-59 months of age and their mothers/caregivers from the 13,200 households (734 per district). The primary (PSUs) and secondary sampling units (SSUs) will include villages and households respectively.

Eligibility criteria: All those households are eligible to be included in the study who have:

* An under-five child with a mother registered with Benazir Income Support Program (BISP)
* Both available at the time of interview

Exclusion criteria includes:

• Mother of the child who is not a woman of reproductive age, i.e., less than 15 years or greater than 49 years

Primary outcomes:
measure: Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
timeFrame: 3 years (on study completion)
Secondary outcomes:
measure: Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of food insecurity status at household level
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of institutional deliveries
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of skilled birth attendance
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of infants who were ever breastfed
timeFrame: 3 years (on study completion)
measure: Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
timeFrame: 3 years (on study completion)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, PhD, FRC
role: PRINCIPAL_INVESTIGATOR
References: