NCT03576157

Brief Summary

British Broadcasting Corporation (BBC) Media Action is presently implementing two large scale mobile health (mHealth) initiatives in India: Kilkari and Mobile Academy. Kilkari is an outbound service that delivers weekly, time-appropriate audio messages about pregnancy, childbirth, and childcare directly to families on their mobile phones, starting from the second trimester of pregnancy until the child is one-year-old. Mobile Academy (MA) is an Interactive Voice Response (IVR) in-service audio training course for Accredited social health activists (ASHAs) in India designed to refresh their knowledge of life-saving preventative health behaviors and improve their interpersonal communications skills. Both programs were initiated in Bihar in 2012, and have been scaled widely in a number of states with support from Ministry of Health and Family Welfare (MOHFW) at the national level, National Health Missions (NHM) at the state level, and an alliance of donors (Gates Foundation, USAID, Barr Foundation, and UK Department for International Development (UKAid)). The Johns Hopkins School of Public Health, Oxford Policy Management, and University of Cape Town are supporting BBC Media Action and the Ministry of Health and Family Welfare (MOHFW) are conducting an external evaluation of both Kilkari and Mobile Academy (MA). The evaluation spans through April 2020.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,095

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 22, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

July 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

June 22, 2018

Last Update Submit

September 28, 2022

Conditions

Keywords

mobile health, Pregnant and postpartum women, Frontline health workers, India

Outcome Measures

Primary Outcomes (2)

  • Exclusive breastfeeding

    The study aims to detect a 5% change in the proportion of women who report practicing exclusive breastfeeding

    0-6 months following delivery

  • Immediate breastfeeding

    The study aims to detect a 5% change in the proportion of women who report practicing immediate breastfeeding

    1 hour following delivery

Study Arms (2)

Kilkari

EXPERIMENTAL

Pregnant and postpartum women randomized to the Kilkari arm will receive health information messages over their mobile phone during pregnancy and up to 1 year postpartum.

Other: Kilkari

Comparison

NO INTERVENTION

Existing standard of care; no new health messages

Interventions

KilkariOTHER

Kilkari is an outbound service that delivers weekly, time-appropriate audio messages about pregnancy, childbirth, and childcare directly to families on their mobile phones, starting from the second trimester of pregnancy until the child is one-year-old.

Kilkari

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen 5-7 months pregnant
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years 5-7 months pregnant Resident of study area Consents to participation Access to a mobile phone during morning and afternoon

You may not qualify if:

  • \<15 years of age Not female Not a resident of study area \<5 months and \>8 months pregnant Not a Hindi speaker Access to a mobile phone only during the night

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

N/A-- recruitment occurring at household / community level in 4 districts: Rewa, Rajgarh, Mandsaur, Hoshangabad

Rewa, Madhya Pradesh, India

Location

BBC Media Action

Delhi, India

Location

Related Publications (7)

  • LeFevre AE, Mendiratta J, Jo Y, Chamberlain S, Ummer O, Miller M, Scott K, Shah N, Chakraborty A, Godfrey A, Dutt P, Mohan D. Cost-effectiveness of a direct to beneficiary mobile communication programme in improving reproductive and child health outcomes in India. BMJ Glob Health. 2023 Mar;6(Suppl 5):e009553. doi: 10.1136/bmjgh-2022-009553.

  • Bashingwa JJH, Mohan D, Chamberlain S, Scott K, Ummer O, Godfrey A, Mulder N, Moodley D, LeFevre AE. Can we design the next generation of digital health communication programs by leveraging the power of artificial intelligence to segment target audiences, bolster impact and deliver differentiated services? A machine learning analysis of survey data from rural India. BMJ Open. 2023 Mar 17;13(3):e063354. doi: 10.1136/bmjopen-2022-063354.

  • LeFevre AE, Shah N, Scott K, Chamberlain S, Ummer O, Bashingwa JJH, Chakraborty A, Godfrey A, Dutt P, Ved R, Mohan D; Kilkari Impact Evaluation Team. The impact of a direct to beneficiary mobile communication program on reproductive and child health outcomes: a randomised controlled trial in India. BMJ Glob Health. 2022 Jul;6(Suppl 5):e008838. doi: 10.1136/bmjgh-2022-008838.

  • Ng A, Mohan D, Shah N, Scott K, Ummer O, Chamberlain S, Bhatnagar A, Dhar D, Agarwal S, Ved R, LeFevre AE; Kilkari Impact Evaluation Team. Assessing the reliability of phone surveys to measure reproductive, maternal and child health knowledge among pregnant women in rural India: a feasibility study. BMJ Open. 2022 Mar 10;12(3):e056076. doi: 10.1136/bmjopen-2021-056076.

  • Chakraborty A, Mohan D, Scott K, Sahore A, Shah N, Kumar N, Ummer O, Bashingwa JJH, Chamberlain S, Dutt P, Godfrey A, LeFevre AE; Kilkari Impact Evaluation Team. Does exposure to health information through mobile phones increase immunisation knowledge, completeness and timeliness in rural India? BMJ Glob Health. 2021 Jul;6(Suppl 5):e005489. doi: 10.1136/bmjgh-2021-005489.

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

  • LeFevre A, Agarwal S, Chamberlain S, Scott K, Godfrey A, Chandra R, Singh A, Shah N, Dhar D, Labrique A, Bhatnagar A, Mohan D. Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial. Trials. 2019 May 15;20(1):272. doi: 10.1186/s13063-019-3369-5.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Amnesty E LeFevre, PhD

    Johns Hopkins School of Public Health, University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2018

First Posted

July 3, 2018

Study Start

July 7, 2018

Primary Completion

March 20, 2020

Study Completion

December 31, 2021

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

De-identified data may be made available upon request to study investigators following the publication of study findings.

Locations