NCT06025786

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,200

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Dec 2021Jun 2026

Study Start

First participant enrolled

December 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

September 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4.1 years

First QC Date

August 16, 2023

Last Update Submit

September 8, 2023

Conditions

Keywords

Quasi experimental studyMaternal and child nutritionStuntingWastingUnder-five malnutritionSpecialized Nutritious Food (SNF)

Outcome Measures

Primary Outcomes (1)

  • 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

    3 years (on study completion)

Secondary Outcomes (10)

  • Baseline to end-line change in the prevalence of underweight women of reproductive age (15-49 years)

    3 years (on study completion)

  • Baseline to end-line change in the prevalence of wasting among children 0-59 months of age

    3 years (on study completion)

  • Baseline to end-line change in the prevalence of food insecurity status at household level

    3 years (on study completion)

  • Baseline to end-line change in the number of antenatal care (ANC) visits during pregnancy

    3 years (on study completion)

  • Baseline to end-line change in the prevalence of institutional deliveries

    3 years (on study completion)

  • +5 more secondary outcomes

Study Arms (2)

Districts with established and operational BNP implementation

EXPERIMENTAL

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.

Combination Product: Benazir Nashonuma Program (BNP)

Districts without BNP implementation and functionality

NO INTERVENTION

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.

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. 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

Districts with established and operational BNP implementation

Eligibility Criteria

Age1 Day - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 75290, Pakistan

RECRUITING

Related Publications (1)

  • Muhammad S, Malik AA, Soofi S, Habib A, Umer M, Rizvi A, Ahmed I, Leroy J, Cousens S, Bhutta ZA. Impact assessment of Benazir Nashonuma Programme (BNP) on maternal, child health and nutritional status in Pakistan: a quasi-experimental study protocol. BMJ Open. 2025 Jun 27;15(6):e094565. doi: 10.1136/bmjopen-2024-094565.

MeSH Terms

Conditions

Growth DisordersCachexiaAnemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Zulfiqar A Bhutta, PhD, FRC

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajid Bashir Soofi, MD, CPSP

CONTACT

Shah Muhammad, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished University Professor and Founding Director of the Institute for Global Health and Development and the Centre of Excellence in Women and Child Health

Study Record Dates

First Submitted

August 16, 2023

First Posted

September 6, 2023

Study Start

December 1, 2021

Primary Completion

December 20, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

September 11, 2023

Record last verified: 2023-07

Locations