NCT00715936

Brief Summary

The purpose of this study is to evaluate whether the integration of an early child 'stimulation and care for development' intervention, either alone or in combination with an 'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial outcomes on child development (cognitive, language, motor and social emotional development) and child growth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,489

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

July 14, 2008

Last Update Submit

June 27, 2017

Conditions

Early Child Development and Growth

Keywords

Integrated early child development, growth and healthPsychosocial stimulationCare for child development

Outcome Measures

Primary Outcomes (2)

  • Early Child Development

    Cognitive, Language, Motor, Social-Emotional development

    24 months of child age

  • Child Growth

    Length/Height, Weight, Mid Arm Circumference, Head Circumference

    24 months of child age

Secondary Outcomes (7)

  • Caregiving Mediators: Maternal Psychological Distress (Depression)

    Baseline, 6 months, 12 months, 18 months and 24 months of child age

  • Caregiving mediators: Caregiving Environment

    6 months and 18 months of child age

  • Caregiving Mediator: Mother/Child Interaction

    12 months and 24 months of child age

  • Caregiving Mediator: Care for Development

    Baseline, 12 months and 24 months of child age

  • Caregiving Mediator: Feeding Practices

    Baseline, 6 months, 12 months, 18 months and 24 months of child age

  • +2 more secondary outcomes

Study Arms (4)

Control

ACTIVE COMPARATOR

Routine services for infants and young children delivered by the Lady Health Workers of the National Programme for Family Planning and Primary Healthcare (Basic Health and Nutrition Education and Services)

Behavioral: Control

ECD Group

EXPERIMENTAL

Stimulation and care for development (plus basic health and nutrition education and services)

Behavioral: ECD

Enhanced Nutrition

EXPERIMENTAL

Care for Nutrition: Enhanced education messages and Sprinkles for children aged 6-24 months (plus basic health and nutrition education and services)

Behavioral: Enhanced Nutrition

ECD and Enhanced Nutrition

EXPERIMENTAL

Stimulation and care for development and care for nutrition (plus basic health and nutrition education and services)

Behavioral: ECDBehavioral: Enhanced Nutrition

Interventions

ControlBEHAVIORAL
Control
ECDBEHAVIORAL
ECD GroupECD and Enhanced Nutrition
Enhanced NutritionBEHAVIORAL
ECD and Enhanced NutritionEnhanced Nutrition

Eligibility Criteria

Age1 Day - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children born in the defined geographical area of study during the study enrollment period will be eligible for the study along with their primary care giver (mother). Infant must be 1d-2.5m of age at time of enrolment.

You may not qualify if:

  • Children born with profound severe disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Project Office, Dept of Paediatrics and Child Health, AKU

Naushero Feroze, Sindh, 75300, Pakistan

Location

Related Publications (2)

  • Yousafzai AK, Obradovic J, Rasheed MA, Rizvi A, Portilla XA, Tirado-Strayer N, Siyal S, Memon U. Effects of responsive stimulation and nutrition interventions on children's development and growth at age 4 years in a disadvantaged population in Pakistan: a longitudinal follow-up of a cluster-randomised factorial effectiveness trial. Lancet Glob Health. 2016 Aug;4(8):e548-58. doi: 10.1016/S2214-109X(16)30100-0. Epub 2016 Jun 21.

    PMID: 27342433DERIVED

  • Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. Lancet. 2014 Oct 4;384(9950):1282-93. doi: 10.1016/S0140-6736(14)60455-4. Epub 2014 Jun 16.

    PMID: 24947106DERIVED

Study Officials

  • Zulfiqar A Bhutta, MBBS, PhD

    Aga Khan University

    STUDY CHAIR

  • Aisha K Yousafzai, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 15, 2008

Study Start

July 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

PA(1)