Evaluating Effects of Integrating ECD Activities Into Bangladesh Government's Urban Lactating Mothers Allowance Program for the Poor on Children's Cognition and Behavior in Rangpur City Corporation, Bangladesh

NCT03753646 | Unknown

• 1 other identifier: PR-18035
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Burden: Provision of health care to urban poor population is a great challenge because of supply and demand barriers in the urban health system, which is considered patchy and fragmented. The poor urban people, especially mothers have little access to government health facilities. The health care platform is not well designed in primary health care delivery for urban health system but presently almost 30 percent people are living in urban area of the country. Knowledge gap: Little is known about what happen if psycho social stimulation is provided using urban lactating allowance program on children's cognition and behavior. There is little information about nature and bottleneck of Early Childhood Development (ECD) activities available in the urban Bangladesh. Relevance: This is an opportunity to develop a combined package integrating psycho social stimulation with the existing urban lactating allowance program on disadvantaged children's development. As the urban health system is complex, patchy and fragmented, prior to this intervention An analysis will be done on ECD services and its bottleneck in urban area through Tanahashi framework. Hypothesis (if any): Adding psycho social stimulation to urban lactating allowance program will have additional effect on children's cognitive, motor and language development and behavior compared to the comparison group Secondary Hypothesis: Additionally the intervention will- improve mothers' quality of life and reduce their depressive symptoms be cost effective, Objectives:

• To evaluate the effect of integrated urban lactating allowance and psycho social stimulation on children's cognitive, motor and language development and behavior
• To measure nature and bottleneck of ECD services in urban Bangladesh Secondary objectives: To measure effect of the programs on:
• mothers' quality of life and mental health (depression symptoms)
• cost effectiveness of the intervention Methods: A two-arm, Cluster Randomized Controlled Trial: i) Lactating allowance + Psycho social stimulation; (ii) Only lactating allowance Outcome measures/variables: Children's cognitive, motor and language development measured on Bayley-III, behavior on Wolke's rating scales, Mother's quality of life and depressive symptoms , household food security status, socioeconomic status, quality of home stimulation using family care indicators, Mother's knowledge on child care and development, children's growth measured by length/height, weight and head circumference,mothers' height, weight and mid upper arm circumference, direct and indirect cost of the project.

Conditions

Early Childhood Development

Keywords

Bangladesh; Cognitive development; behavior; quality of life; psycho social stimulation; lactating allowance

Outcome Measures

Primary Outcomes (8)

• Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III)

  Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status

  Children's cognitive composite score ranging from 55 to 145 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention

• Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)

  Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status

  Children's language composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention

• Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III)

  Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III). Higher values represent a better status

  Children's motor composite score ranging from 45 to 155 using Bayley Scales of Infant and Toddler Development (Bayley-III) after one year intervention

• Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9

  Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status

  Children's approach behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention

• Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9

  Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status

  Children's general emotion tone behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention

• Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9

  Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a more active status.

  Children's activity behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention

• Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9

  Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status

  Children's cooperation behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention

• Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9

  Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 during Bayley. Higher values represent a better status

  Children's vocalization behaviour using Wolk's behavior rating scale ranging from 1 to 9 after one year intervention

Secondary Outcomes (12)

• Children's weight

  Change children's weight after one year intervention

• Children's height

  Change children's height after one year intervention

• Children's Mid Upper Arm circumference (MUAC)

  Change children's MUAC after one year intervention

• Mothers' weight

  Change mother's weight after one year intervention

• Mothers' height

  Change mother's height after one year intervention

Other Outcomes (3)

• Family's health seeking behavior

  Change family's health seeking behaviour status after one year intervention

• Family's income

  Change family's income status after one year intervention

• Family's expenditure

  Change family's expenditure status after one year intervention

Study Arms (2)

Lactating allowance and psycho social stimulation

EXPERIMENTAL

Mothers will receive lactating allowance and psycho social stimulation

Other: Lactating allowance and psycho social stimulation

Only lactating allowance

NO INTERVENTION

Mothers will receive only lactating allowance

Interventions

Lactating allowance and psycho social stimulation OTHER

Mothers will receive lactating allowance and psycho social stimulation

Lactating allowance and psycho social stimulation

Eligibility Criteria

• Age: 6 Months - 16 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Mothers with a child aged 6-16 months
• Not expected to leave the study site for more than 2 months
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

You may not qualify if:

• Legal guardian unwilling or unable to provide written informed consent.
• Known congenital anomaly, developmental disorder or severe developmental delay
• If not possible to test the child due to physical or behavioural problems
• Children of multiple birth e.g. twin, triplets

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (7)

• Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, McCoy DC, Fink G, Shawar YR, Shiffman J, Devercelli AE, Wodon QT, Vargas-Baron E, Grantham-McGregor S; Lancet Early Childhood Development Series Steering Committee. Early childhood development coming of age: science through the life course. Lancet. 2017 Jan 7;389(10064):77-90. doi: 10.1016/S0140-6736(16)31389-7. Epub 2016 Oct 4.

  PMID: 27717614 BACKGROUND

• Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, Grantham-McGregor SM. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014 Oct;134(4):e1001-8. doi: 10.1542/peds.2014-0694.

  PMID: 25266433 BACKGROUND

• Afsana K, Wahid SS. Health care for poor people in the urban slums of Bangladesh. Lancet. 2013 Dec 21;382(9910):2049-51. doi: 10.1016/S0140-6736(13)62295-3. Epub 2013 Nov 21. No abstract available.

  PMID: 24268606 BACKGROUND

• Robertson L, Mushati P, Eaton JW, Dumba L, Mavise G, Makoni J, Schumacher C, Crea T, Monasch R, Sherr L, Garnett GP, Nyamukapa C, Gregson S. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial. Lancet. 2013 Apr 13;381(9874):1283-92. doi: 10.1016/S0140-6736(12)62168-0. Epub 2013 Feb 27.

  PMID: 23453283 BACKGROUND

• Pega F, Liu SY, Walter S, Pabayo R, Saith R, Lhachimi SK. Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low- and middle-income countries. Cochrane Database Syst Rev. 2017 Nov 15;11(11):CD011135. doi: 10.1002/14651858.CD011135.pub2.

  PMID: 29139110 BACKGROUND

• Ahmed SM, Evans TG, Standing H, Mahmud S. Harnessing pluralism for better health in Bangladesh. Lancet. 2013 Nov 23;382(9906):1746-55. doi: 10.1016/S0140-6736(13)62147-9. Epub 2013 Nov 21.

  PMID: 24268003 BACKGROUND

• Hossain SJ, Rahman SM, Fisher J, Rahman A, Tofail F, Hamadani JD. Effect of a parenting and nutrition education programme on development and growth of children using a social safety-net platform in urban Bangladesh: a cluster randomized controlled trial. Lancet Reg Health Southeast Asia. 2024 Mar 19;25:100388. doi: 10.1016/j.lansea.2024.100388. eCollection 2024 Jun.

  PMID: 38550293 DERIVED

MeSH Terms

Conditions

Behavior

Central Study Contacts

Sheikh Jamal Hossain, MPH

CONTACT

02-01712191414; sheikh.jamal@icddrb.org

Jena D Hamadani, PhD

CONTACT

02-01713093849; jena@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Assessor who will measure children's cognitive development and behavor and other measurements will be masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will integrate ECD services to Bangladesh government lactating allowance to measure children's neurocognitive behavior in urban area of Bangladesh.

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 27, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)