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Nutrition Intervention Integrated With Food Voucher to Improve Child Growth and Feeding Practices

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ClinicalTrials.gov Identifier: NCT03641001
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : March 16, 2021
Sponsor:
Collaborator:
Brac
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

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. 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. To improve young child feeding practices following counselling

Methods:

This will be a community based cluster randomized trial. Group I (intervention) will receive a package of intervention (child feeding counselling, WASH and micronutrient powder) along with food voucher to support feeding their children a homemade snack following a newly developed recipe (suzi firni for <1 year, suzi halua for >1 yr) and Group II (Control) will receive usual health meassages. Baseline and endline survey will be conducted. Growth Monitoring Promotion (GMP) will be done monthly to monitor the growth of the children and utilization of food voucher. Data on child feeding, morbidity and anthropometry (length and weight) will be collected monthly.

Outcome measures/variables:

  1. Difference in mean LAZ of the children between intervention and control group
  2. Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group
  3. Difference in proportions of mothers in terms of correct knowledge and practice on CF

Condition or disease Intervention/treatment Phase
Child Malnutrition Feeding Behavior Growth; Stunting, Nutritional Behavioral: Child feeding counselling, food voucher, micronutrient powder, WASH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Community based Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Nutrition Intervention (Counselling, Food Voucher for Recipe, WASH and Home Fortification) on Growth and Feeding Practices of Under Two Years Children in Rural Bangladesh"
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: Intervention
Intervention group will receive child feeding counselling, food voucher for recipe, WASH and home fortification
Behavioral: Child feeding counselling, food voucher, micronutrient powder, WASH
Child feeding counselling will be assisted by food voucher, micronutrient powder and WASH messages

No Intervention: Control
Control will receive usual health messages from government and NGO



Primary Outcome Measures :
  1. Length for age Z-score (LAZ) [ Time Frame: 12 months ]
    difference of 0.4 SD in LAZ between intervention and control group


Secondary Outcome Measures :
  1. weight for age Z-score (WAZ) [ Time Frame: 12 months ]
    Difference in mean weight for age Z-score (WAZ) of the children between intervention and control group at endline



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641001


Contacts
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Contact: Gulshan Ara, M.Sc +88029827001 ext 2336 gulshan.ara@icddrb.org
Contact: Kazi Istiaque Sanin, MBBS +88029827001 ext 8824 sanin@icddrb.org

Locations
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Bangladesh
Community Recruiting
Dhaka, Bangladesh
Contact: Razia Sultana, M.Sc    +8801712692251    rita@icddrb.org   
Contact: Tanvir Jami, M.Com    +8801716964351    tanvirjami@gmail.com   
Principal Investigator: Gulshan Ara, M.Sc         
Sub-Investigator: Kazi Istiaque Sanin, MBBS         
Sub-Investigator: Tahmeed Ahmed, PhD         
Sub-Investigator: Shafiqul Alam Sarkar, PhD         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Brac
Investigators
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Principal Investigator: Gulshan Ara, M.Sc International Centre for Diarrhoeal Disease Research, Bangladesh
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03641001    
Other Study ID Numbers: PR 17083
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Intervention
Food voucher
Child feeding
Growth
WASH
Additional relevant MeSH terms:
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Malnutrition
Child Nutrition Disorders
Nutrition Disorders
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs