- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025786
Impact Evaluation of Benazir Nashonuma Program (BNP) on Stunting Among Under-five Children
Impact Assessment of Benazir Nashonuma Program (BNP) on Stunting Prevention Among Children 0-59 Months of Age in Pakistan
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sajid Bashir Soofi, MD, CPSP
- Phone Number: +923002769398
- Email: sajid.soofi@aku.edu
Study Contact Backup
- Name: Shah Muhammad, MD
- Phone Number: +923325590559
- Email: shah.muhammad@aku.edu
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan, 75290
- Recruiting
- Aga Khan University
-
Contact:
- Asma Abdul Malik, MBBS, MSc
- Phone Number: +923311388051
- Email: asma.qureshi@aku.edu
-
Contact:
- Shah Mohammad
- Email: shah.muhammad@aku.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Districts with established and operational BNP implementation
The intervention arm consists of nine districts from four provinces and two regions of Pakistan where the Benazir Nashonuma Program (BNP) is operational, providing reproductive and healthcare services to pregnant women and their children under the age of two.
|
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. Conditional Cash Transfer (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 |
|
No Intervention: Districts without BNP implementation and functionality
The control arm comprises of nine districts where Benazir Nashonuma Program (BNP) has not been implemented.
These districts are comparable to their respective intervention districts in terms of average maternal BMI and prevalence of stunting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
Time Frame: 3 years (on study completion)
|
Height-for-age ≤-2 SD of the WHO Child growth standards median
|
3 years (on study completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
Time Frame: 3 years (on study completion)
|
WRA with a Body Mass Index (BMI) less than 18.5 kg/m2 will be considered underweight
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
Time Frame: 3 years (on study completion)
|
Weight-for-height ≤-2 SD of the WHO Child growth standards median
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of food insecurity status at household level
Time Frame: 3 years (on study completion)
|
Food Insecurity Experience Scale (FIES) by Food and Agriculture Organization (FAO) is experience-based measures of household or individual food security.
It consists of eight questions regarding people's access to adequate food in last 12 months due to lack of money or other resources.
Food insecurity is reported as mild, moderate and severe.
|
3 years (on study completion)
|
|
Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
Time Frame: 3 years (on study completion)
|
Number of antenatal care (ANC) visits done during the preceding pregnancy, leading to a live birth within the last two years.
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of institutional deliveries
Time Frame: 3 years (on study completion)
|
Number of women who gave birth at a healthcare facility during the preceding pregnancy, leading to a live birth within the last two years.
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of skilled birth attendance
Time Frame: 3 years (on study completion)
|
Number of women whose birth was attended by a skilled health personnel during the preceding pregnancy, leading to a live birth within the last two years.
|
3 years (on study completion)
|
|
Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
Time Frame: 3 years (on study completion)
|
Consumption of iron folic acid tablets during pregnancy
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
Time Frame: 3 years (on study completion)
|
Consumption of at least five out of the ten food groups during the previous day and night (24 hours)
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of infants who were ever breastfed
Time Frame: 3 years (on study completion)
|
Number of infants who were breastfed at least once
|
3 years (on study completion)
|
|
Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
Time Frame: 3 years (on study completion)
|
Number of infants who were fed exclusively with breast milk during the previous day
|
3 years (on study completion)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zulfiqar A Bhutta, PhD, FRC, Aga Khan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNP Quasi Experimental Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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