Improving Growth and Cognitive Development of the Disadvantaged Young Children in Resource Poor Setting

NCT05805514 | Unknown DMC

• 1 other identifier: PR-22122
• Study Type: interventional
• Target: 627
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Burden:
2. 2.Knowledge gap:
3. 3.Hypothesis:
4. 4.Objective:
5. 5.Methods:

Conditions

Complementary Feeding

Keywords

Child undernutrition; Cognitive development; Animal source food; Psychosocial stimulation; Complementary feeding; Nutrition education counselling

Outcome Measures

Primary Outcomes (2)

• To change the nutritional status under-two (6-23 mo) year children (a difference of 0.35 SD in the length-for-age z-score) from food insecure, low-income families in rural Bangladesh after receiving comprehensive intervention for 12 months

  • Difference in length-for-age z-score after 12 months (length measured in centimeters) (intervention vs control)

  Anthropometry will be collected in every three months till 12 months

• To change the developmental outcome of the under-two (6-23 mo) year children

  Differences in children's cognition, language (expressive and receptive), motor (fine and gross motor) and behavioural development will be assessed by Bayley Scales after 12 months (intervention vs control)

  Child developmental assessment will be done before and after 12 months of intervention

Secondary Outcomes (2)

• To change the dietary diversity of the under-two (6-23 mo) year children

  • Differences in percentage of children at 6, 9, 12 months who receive complementary feeds • Differences in percentage of children consuming foods from >4 food groups

• To change hand washing and sanitation practice

  Hand washing and sanitation practice assessment will be done before and after 12 months of intervention

Study Arms (3)

Food and psychosocial intervention

EXPERIMENTAL

In Food and psychosocial intervention, the nutrition workers will be responsible for providing egg through food voucher, psychosocial stimulation, nutrition education counselling, child water, sanitation and hygiene message, and multiple micronutrient powder among the selected mothers/infant pairs.

Other: Animal source of food and psychosocial stimulation

Food intervention

EXPERIMENTAL

In Food intervention, nutrition workers will give food egg, nutrition education counselling, water, sanitation and hygiene message, and multiple micronutrient powder among the selected mothers/infant pairs.

Other: Animal source of food

Control

PLACEBO COMPARATOR

In terms of control group, the nutrition workers will provide only nutrition education counselling among the selected mother-child pairs.

Other: Control

Interventions

Animal source of food and psychosocial stimulation OTHER

209 mother-child pair will receive the animal source of food and psychosocial stimulation for 12 months. Child will be recruited within 6-12 months.

Food and psychosocial intervention

Animal source of food OTHER

209 mother-child pair will receive the animal source of food for 12 months. Child will be recruited within 6-12 months.

Food intervention

Control OTHER

209 mother-child pair will receive the control package for 12 months. Child will be recruited within 6-12 months.

Control

Eligibility Criteria

• Age: 6 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6-15 months
• Households having moderate to severe food insecurity
• Households having monthly income \< BDT 10,000
• Households dependent on irregular income
• Households have plan to stay in the study area for next 1 year
• Households not involved with any nutrition or social safety net programme

You may not qualify if:

• Children aged less than 6 months
• Children aged more than 15 months
• Households having regular income and monthly income is more than BDT 10000
• Households involved in any nutrition or social safety net programme

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Atpara

Netrakona, Bangladesh

RECRUITING

Related Publications (10)

• World Health Organization, 2003. Complementary feeding: report of the global consultation, and summary of guiding principles for complementary feeding of the breastfed child.

  RESULT

• Ravi, S. and Engler, M., 2015. Workfare as an effective way to fight poverty: The case of India's NREGS. World Development, 67, pp.57-71.

  RESULT

• Walker, S., 2020. The Impact of Dietary Egg Intake on Metabolic Health in Food Insecure Households. University of Arkansas.

  RESULT

• Headey D, Hirvonen K, Hoddinott J. Animal Sourced Foods and Child Stunting. Am J Agric Econ. 2018 Jul 31;100(5):1302-1319. doi: 10.1093/ajae/aay053.

  PMID: 33343003 RESULT

• Innis SM. Dietary (n-3) fatty acids and brain development. J Nutr. 2007 Apr;137(4):855-9. doi: 10.1093/jn/137.4.855.

  PMID: 17374644 RESULT

• Horton, S. and Steckel, R.H., 2013. Malnutrition: global economic losses attributable to malnutrition 1900-2000 and projections to 2050. How Much Have Global Problems Cost the Earth? A Scorecard from 1900 to, 2050, pp.247-272.

  RESULT

• Hamadani JD, Tofail F, Hilaly A, Huda SN, Engle P, Grantham-McGregor SM. Use of family care indicators and their relationship with child development in Bangladesh. J Health Popul Nutr. 2010 Feb;28(1):23-33. doi: 10.3329/jhpn.v28i1.4520.

  PMID: 20214083 RESULT

• Wolke D, Skuse D, Mathisen B. Behavioral style in failure-to-thrive infants: a preliminary communication. J Pediatr Psychol. 1990 Apr;15(2):237-54. doi: 10.1093/jpepsy/15.2.237.

  PMID: 2374078 RESULT

• Ara G, Khanam M, Papri N, Nahar B, Kabir I, Sanin KI, Khan SS, Sarker MSA, Dibley MJ. Peer Counseling Promotes Appropriate Infant Feeding Practices and Improves Infant Growth and Development in an Urban Slum in Bangladesh: A Community-Based Cluster Randomized Controlled Trial. Curr Dev Nutr. 2019 Jun 18;3(7):nzz072. doi: 10.1093/cdn/nzz072. eCollection 2019 Jul.

  PMID: 31334480 RESULT

• Bayley, N., 2006. Bayley scales of infant and toddler development.

  RESULT

Study Officials

• Gulshan Ara, MSc, MPH

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulshan Ara, MSc, MPH

CONTACT

+8801925902383; gulshan.ara@icddrb.org

Samira Dilruba Ali, MSc

CONTACT

+8801759914929; samira.ali@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a community based randomized cobtrolled trial. Participants, care provider and investigator will know the intervention. Outcomes assessor (e.g. Anthrpometric measurer and psychosocial stimulation evaluator) will not know about the participant allocation and major outcome of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will perform a post hoc test, which will enable us to examine the difference between various group means while simultaneously controlling for the family-wise error rate, to determine precisely which groups are distinct from one another. We will use linear mixed models for continuous outcomes (e.g. Bayley scores) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes). Models will include a fixed effect, children as a random effect to account for the repeated measurements, and community-cluster as a random effect to account for the cluster effect. The models will be able to evaluate the impact of the interventions over time by testing for an interaction between time and intervention group. Analyses will be conducted to identify the baseline characteristics of mother-infant dyads who may benefit most from the intervention. Model assumptions will be checked and appropriate adjustments to the analysis will be made where necessary.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: April 10, 2023
• Study Start: February 20, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)