NCT03641001

Brief Summary

Brief Summary: Background: The period from birth to two years of age is the "critical window" for the promotion of optimal growth, health, and development. Insufficient quantities and inadequate quality of complementary foods, poor child-feeding practices and high rates of infections have a detrimental impact on growth. Approximately one-third of children less than 5 years of age in developing countries are stunted, and large proportions are also deficient in one or more micronutrients. An estimated 6% or 6 hundred thousand under-5 deaths can be prevented by ensuring optimal complementary feeding (CF) only. Knowledge gap: Even though the importance of CF is established, children \< 2y are being fed complementary foods with poor nutrient quality, particularly in resource poor countries like Bangladesh. Relevance: Approximately 36% under 5 children are stunted in Bangladesh. Only 23% of children age 6-23 months is fed appropriately based on recommended infant and young child feeding (IYCF) practices. The routine diet of the population including children is mainly plant based and lacks adequate protein and other essential nutrients. Hygiene is also an issue as only 21% of rural households use soap and water during handwashing. An intervention package including CF counselling, WASH and micronutrient powder (MNP) could be potential option for optimizing complementary feeding practice in rural Bangladesh. Hypothesis: An integrated intervention package will improve child growth in terms of length and complementary feeding practice in the selected intervention area from rural Bangladesh compared to control area. Objectives:

  1. 1.To improve nutritional status (length for age Z-score or LAZ) of the children (6-12 mo) through food voucher to promote improved recipe and intervention package with 12 months of intervention period.
  2. 2.To improve young child feeding practices following counselling
  3. 3.Difference in mean LAZ of the children between intervention and control group
  4. 4.Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group
  5. 5.Difference in proportions of mothers in terms of correct knowledge and practice on CF

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
410

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

August 13, 2018

Last Update Submit

February 10, 2022

Conditions

Keywords

InterventionFood voucherChild feedingGrowthWASH

Outcome Measures

Primary Outcomes (1)

  • Length for age Z-score (LAZ)

    difference of 0.4 SD in LAZ between intervention and control group

    12 months

Secondary Outcomes (1)

  • weight for age Z-score (WAZ)

    12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will receive child feeding counselling, food voucher for recipe, WASH and home fortification

Behavioral: Child feeding counselling, food voucher, micronutrient powder, WASH

Control

NO INTERVENTION

Control will receive usual health messages from government and NGO

Interventions

Child feeding counselling will be assisted by food voucher, micronutrient powder and WASH messages

Intervention

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Households having under two years children (6-12 mo during enrolment)
  • Household listed as poor household
  • Not involved with any government/non-government microfinance programme
  • Not participants of any IYCF programme

You may not qualify if:

  • Children with Severe Acute Malnutrition (SAM) or LAZ \< -3SD of reference as per guideline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

Dhaka, Bangladesh

RECRUITING

Related Publications (1)

  • Ara G, Sanin KI, Khanam M, Sarker MSA, Tofail F, Nahar B, Chowdhury IA, Boitchi AB, Gibson S, Afsana K, Askari S, Ahmed T. A comprehensive intervention package improves the linear growth of children under 2-years-old in rural Bangladesh: a community-based cluster randomized controlled trial. Sci Rep. 2022 Dec 19;12(1):21962. doi: 10.1038/s41598-022-26269-w.

MeSH Terms

Conditions

Child Nutrition DisordersFeeding BehaviorGrowth Disorders

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesBehavior, AnimalBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Gulshan Ara, M.Sc

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulshan Ara, M.Sc

CONTACT

Kazi Istiaque Sanin, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Community based Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 21, 2018

Study Start

January 1, 2018

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

February 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations