search
Back to results

Impact Evaluation of Benazir Nashonuma Program (BNP) on Stunting Among Under-five Children

Primary Purpose

Stunting, Wasting, Anemia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Benazir Nashonuma Program (BNP)
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stunting focused on measuring Quasi experimental study, Maternal and child nutrition, Stunting, Wasting, Under-five malnutrition, Specialized Nutritious Food (SNF)

Eligibility Criteria

1 Day - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aga Khan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Districts with established and operational BNP implementation

Districts without BNP implementation and functionality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
Height-for-age ≤-2 SD of the WHO Child growth standards median

Secondary Outcome Measures

Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
WRA with a Body Mass Index (BMI) less than 18.5 kg/m2 will be considered underweight
Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
Weight-for-height ≤-2 SD of the WHO Child growth standards median
Baseline to end-line change in the prevalence of food insecurity status at household level
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.
Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
Number of antenatal care (ANC) visits done during the preceding pregnancy, leading to a live birth within the last two years.
Baseline to end-line change in the prevalence of institutional deliveries
Number of women who gave birth at a healthcare facility during the preceding pregnancy, leading to a live birth within the last two years.
Baseline to end-line change in the prevalence of skilled birth attendance
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.
Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
Consumption of iron folic acid tablets during pregnancy
Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
Consumption of at least five out of the ten food groups during the previous day and night (24 hours)
Baseline to end-line change in the prevalence of infants who were ever breastfed
Number of infants who were breastfed at least once
Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
Number of infants who were fed exclusively with breast milk during the previous day

Full Information

First Posted
August 16, 2023
Last Updated
September 8, 2023
Sponsor
Aga Khan University
Collaborators
International Food Policy Research Institute, Bill and Melinda Gates Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT06025786
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
December 20, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
International Food Policy Research Institute, Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Wasting, Anemia, Nutrient Deficiency
Keywords
Quasi experimental study, Maternal and child nutrition, Stunting, Wasting, Under-five malnutrition, Specialized Nutritious Food (SNF)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Districts with established and operational BNP implementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Districts without BNP implementation and functionality
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Benazir Nashonuma Program (BNP)
Intervention Description
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
Primary Outcome Measure Information:
Title
Baseline to end-line change in the prevalence of stunting among children 0-59 months of age
Description
Height-for-age ≤-2 SD of the WHO Child growth standards median
Time Frame
3 years (on study completion)
Secondary Outcome Measure Information:
Title
Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)
Description
WRA with a Body Mass Index (BMI) less than 18.5 kg/m2 will be considered underweight
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of wasting among children 0-59 months of age
Description
Weight-for-height ≤-2 SD of the WHO Child growth standards median
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of food insecurity status at household level
Description
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.
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy
Description
Number of antenatal care (ANC) visits done during the preceding pregnancy, leading to a live birth within the last two years.
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of institutional deliveries
Description
Number of women who gave birth at a healthcare facility during the preceding pregnancy, leading to a live birth within the last two years.
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of skilled birth attendance
Description
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.
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in prevalence of utilization of iron folic acid (IFA) during pregnancy
Description
Consumption of iron folic acid tablets during pregnancy
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of Minimum dietary diversity for women (MDDW)
Description
Consumption of at least five out of the ten food groups during the previous day and night (24 hours)
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of infants who were ever breastfed
Description
Number of infants who were breastfed at least once
Time Frame
3 years (on study completion)
Title
Baseline to end-line change in the prevalence of exclusive breastfeeding among infants 0-5 months of age
Description
Number of infants who were fed exclusively with breast milk during the previous day
Time Frame
3 years (on study completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sajid Bashir Soofi, MD, CPSP
Phone
+923002769398
Email
sajid.soofi@aku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shah Muhammad, MD
Phone
+923325590559
Email
shah.muhammad@aku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zulfiqar A Bhutta, PhD, FRC
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75290
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asma Abdul Malik, MBBS, MSc
Phone
+923311388051
Email
asma.qureshi@aku.edu
First Name & Middle Initial & Last Name & Degree
Shah Mohammad
Email
shah.muhammad@aku.edu

12. IPD Sharing Statement

Learn more about this trial

Impact Evaluation of Benazir Nashonuma Program (BNP) on Stunting Among Under-five Children

We'll reach out to this number within 24 hrs