NCT04581993

Brief Summary

Over the years, there has been some progress made in reducing stunting in Afghanistan, the prevalence remains high with half of the provinces experiencing rates above the WHO alert threshold. As part of the Country Strategic Plan (CSP), the World Food Programme (WFP) plans to implement a stunting prevention programme in collaboration with Ministry of Public Health (MoPH) through its Public Nutrition Department (PND) in selected locations with stunting rates above 45%. The programme will emphasis on appropriate nutrition support in the '1000 days' window of opportunity with special focus on proven effective nutrition interventions such appropriate breast feeding, complementary feeding, micronutrient supplementation, malnutrition treatment and prevention, WASH.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

October 8, 2020

Last Update Submit

August 15, 2023

Conditions

StuntingMalnutrition, Child

Keywords

StuntingChildrenSpecialized Nutritious FoodsSocial and Behavior Change CommunicationAfghanistan

Outcome Measures

Primary Outcomes (1)

  • Reduction in stunting

    10% reduction in stunting among children 6-23 months in the intervention compare to control

    18 months

Study Arms (2)

Intervention

EXPERIMENTAL

Pregnant and lactating women (PLW) will receive Super Cereal - wheat soya blend with sugar and children aged 6-23 months will receive lipid-based nutrient supplement-medium quantity (LNS-MQ). Social and behavior change communication (SBCC), community mobilization, referrals, identification of model families, food demonstrations, local recipe) ration/beneficiary entitlement cards will be provided for easy verification and tracking during delivery of intervention.

Dietary Supplement: Super Cereal - wheat soya blend with sugarDietary Supplement: Lipid-based nutrient supplement-medium quantity (LNS-MQ)Behavioral: Social and behavior change communication (SBCC)

Control

NO INTERVENTION

Control districts will receive routine health care services available in the study area.

Interventions

Super Cereal - wheat soya blend with sugarDIETARY_SUPPLEMENT

Pregnant and lactating women will received Super Cereal during pregnancy and first six months of lactation.

Intervention
Lipid-based nutrient supplement-medium quantity (LNS-MQ)DIETARY_SUPPLEMENT

Children will receive LNS during 6-23 months of age.

Intervention
Social and behavior change communication (SBCC)BEHAVIORAL

SBCC will be provided to improve care-givers knowledge, attitudes and practices related to infant and young child feeding.

Intervention

Eligibility Criteria

Age6 Months - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant and lactating women
  • Children 6-23 months
  • Willing to participate

You may not qualify if:

  • Non pregnant and lactating women
  • Children \>24 months
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan Health Services

Fayzabad, Badakhshān, Afghanistan

Location

Related Publications (1)

  • Soofi SB, Khan GN, Sajid M, Hussainyar MA, Shams S, Shaikh M, Ouma C, Azami S, Naeemi M, Hussain A, Umer M, Hussain I, Ahmed I, Ariff S. Specialized nutritious foods and behavior change communication interventions during the first 1000 d of life to prevent stunting: a quasi-experimental study in Afghanistan. Am J Clin Nutr. 2024 Sep;120(3):560-569. doi: 10.1016/j.ajcnut.2024.07.007. Epub 2024 Jul 14.

    PMID: 39004283DERIVED

MeSH Terms

Conditions

Growth DisordersChild Nutrition Disorders

Interventions

Sugars

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Sajid B Soofi, MBBS, FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 9, 2020

Study Start

February 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 16, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

AF(1)