NCT03594279

Brief Summary

Childhood diarrhea and pneumonia remains the leading cause of mortality among children under five years of age in Pakistan. The prevalence of diarrhea in Pakistan has increased from 15% in 1990 to 23% in 2013 while there has been no progress in the prevalence of pneumonia and it has been almost constant over the last two decades. The coverage of preventive and therapeutic interventions for childhood diarrhea and pneumonia also remains low. This study aims to improve the adherence to recommended preventive and curative practices for childhood diarrhea and pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

3.5 years

First QC Date

June 28, 2018

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (9)

  • Age-appropriate immunization 12-23 months

    At six months of intervention

  • ORS use for diarrhea

    At six months of intervention

  • Mean Sanitation Index

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales: 1. Drinking water - possible score of minimum 0 and maximum 3 * Interior water storage container is covered; * Exterior water storage container is cleaned; * Water present in water storage container 2. Food - possible score of minimum 0 and maximum 3 * Clean dishes are covered; * Clean dishes are kept high; * All food is covered 3. Domestic hygiene - possible score of minimum 0 and maximum 6 * No trash outside the house; * No trash inside the house; * No unrestrained animals in patio or house; * No accumulation of dirty clothes; * Insignificant number of flies in house; * No standing water in patio or around house

    At six months of intervention

  • Age-appropriate immunization 12-23 months

    At 12 months of intervention

  • ORS use for diarrhea

    At 12 months of intervention

  • Mean Sanitation Index

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales: 1. Drinking water - possible score of minimum 0 and maximum 3 * Interior water storage container is covered; * Exterior water storage container is cleaned; * Water present in water storage container 2. Food - possible score of minimum 0 and maximum 3 * Clean dishes are covered; * Clean dishes are kept high; * All food is covered 3. Domestic hygiene - possible score of minimum 0 and maximum 6 * No trash outside the house; * No trash inside the house; * No unrestrained animals in patio or house; * No accumulation of dirty clothes; * Insignificant number of flies in house; * No standing water in patio or around house

    At 12 months of intervention

  • Age-appropriate immunization 12-23 months

    At 24 months of intervention

  • ORS use for diarrhea

    At 24 months of intervention

  • Mean Sanitation Index

    The scale is focused on 12 components. All the components are valued equally and can be scored '0' (for 'No') or '1' (for 'Yes'). These would be summed up for each household for a total possible score of 12 and a range of 0-12. Higher score represents a better outcome. It comprises of the following three subscales: 1. Drinking water - possible score of minimum 0 and maximum 3 * Interior water storage container is covered; * Exterior water storage container is cleaned; * Water present in water storage container 2. Food - possible score of minimum 0 and maximum 3 * Clean dishes are covered; * Clean dishes are kept high; * All food is covered 3. Domestic hygiene - possible score of minimum 0 and maximum 6 * No trash outside the house; * No trash inside the house; * No unrestrained animals in patio or house; * No accumulation of dirty clothes; * Insignificant number of flies in house; * No standing water in patio or around house

    At 24 months of intervention

Secondary Outcomes (6)

  • Handwashing with soap at important time

    At 24 months of intervention

  • Exclusive breastfeeding rates - children who are exclusively breastfed at 6 months of age

    At 24 months of intervention

  • Care seeking for severe cases of childhood diarrhea and pneumonia - parents/caregivers who sought care for child with diarrhea/pneumonia

    At 24 months of intervention

  • Prevalence of Diarrhea and pneumonia

    At 24 months of intervention

  • Open defecation rates

    At 24 months of intervention

  • +1 more secondary outcomes

Study Arms (3)

Community Mobilization

EXPERIMENTAL

This arm will receive specific messages regarding the prevention and management of childhood diarrhea and pneumonia. The investigators will form village committees (VC) consisting of prominent members of the community (6-8 in a group) to carry out awareness and motivational activities for the uptake of the identified interventions.

Behavioral: Community MobilizationBehavioral: Community Mobilization and Community Incentive

Community Mobilization and Community Incentive

EXPERIMENTAL

In this arm, along with the interventions in the community mobilization arm, community based incentives will also be provided. The clusters which improve the practices for preventive and curative strategies for diarrhea and pneumonia will receive community-based incentive including structural benefits linked to health including tube wells, water supply, toilets in community/schools, water storage facility or any other incentive as decided with the respective village committees.

Behavioral: Community Mobilization and Community Incentive

Control

NO INTERVENTION

This arm will receive the routine standard of care.

Interventions

Community Mobilization

Community Mobilization

Community Mobilization and Community Incentive

Community MobilizationCommunity Mobilization and Community Incentive

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • People residing in the villages in the selected study site and consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (2)

  • Das JK, Salam RA, Padhani ZA, Rizvi A, Mirani M, Jamali MK, Chauhadry IA, Sheikh I, Khatoon S, Muhammad K, Bux R, Naqvi A, Shaheen F, Ali R, Muhammad S, Cousens S, Bhutta ZA. An innovative Community Mobilisation and Community Incentivisation for child health in rural Pakistan (CoMIC): a cluster-randomised, controlled trial. Lancet Glob Health. 2025 Jan;13(1):e121-e133. doi: 10.1016/S2214-109X(24)00428-5.

  • Das JK, Siddiqui F, Padhani ZA, Khan MH, Jabeen S, Mirani M, Mughal S, Baloch S, Sheikh I, Khatoon S, Muhammad K, Gangwani M, Nathani K, Salam RA, Bhutta ZA. Health behaviors and care seeking practices for childhood diarrhea and pneumonia in a rural district of Pakistan: A qualitative study. PLoS One. 2023 May 16;18(5):e0285868. doi: 10.1371/journal.pone.0285868. eCollection 2023.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The intervention is based on the Behavior Change Theory.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 20, 2018

Study Start

July 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations