NCT05836961

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. 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,500

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Feb 2023Sep 2026

Study Start

First participant enrolled

February 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

May 1, 2023

Status Verified

January 1, 2023

Enrollment Period

2.6 years

First QC Date

March 13, 2023

Last Update Submit

April 28, 2023

Conditions

Keywords

Intervention studyMaternal and child nutritionBenazir Nashonuma Program (BNP)Low birthweightStunting

Outcome Measures

Primary Outcomes (3)

  • Prevalence of low birthweight

    Birth weight of less than 2500 g (up to and including 2499 g) within 48 hours of delivery

    Within 48-hours of delivery

  • Prevalence of stunting

    Height-for-age ≤-2 SD of the WHO Child growth standards median

    At 6 months of age

  • Prevalence of stunting

    Height-for-age ≤-2 SD of the WHO Child growth standards median

    At 12 months of age

Secondary Outcomes (16)

  • Prevalence of wasting

    At 6 and 12 months of age

  • Prevalence of Iron deficiency anemia in pregnant women

    At 9th month on pregnancy

  • Prevalence of Iron deficiency anemia in infants

    2 point times: At 6 and 12 months of age

  • Number of antenatal care (ANC) visits during pregnancy

    At delivery

  • Number of women who had an Institutional delivery

    At delivery

  • +11 more secondary outcomes

Study Arms (2)

BNP enrolled

EXPERIMENTAL

Pregnant women in their first or second trimester who have been enrolled in BNP

Other: Benazir Nashonuma Program (BNP)

BNP non-enrolled

NO INTERVENTION

Pregnant women in their first or second trimester who are not enrolled in BNP

Interventions

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 (1/4 of daily energy requirements for children in this age range) Conditional Cash Transfers (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

BNP enrolled

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan Office

Dadu, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Growth DisordersCachexiaChild Nutrition DisordersAnemia, Iron-DeficiencyFeeding Behavior

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessNutrition DisordersNutritional and Metabolic DiseasesAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesBehavior, AnimalBehavior

Central Study Contacts

Dr Sajid Bashir Soofi

CONTACT

Dr Asma Abdul Malik

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

March 13, 2023

First Posted

May 1, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

May 1, 2023

Record last verified: 2023-01

Locations