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Breast FeedingNCT03576157

Kilkari Impact Evaluation

A study testing Kilkari in people with Breast Feeding and Family Planning, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Kilkari
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,095 participants
Where
2 sitesIndia
Study dates
7 Jul 2018to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 15-45 years 5-7 months pregnant Resident of study area Consents to participation Access to a mobile phone during morning and afternoon

Who cannot join

  • <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

Trial locations and contacts

2 sites in 1 country.

India2 sites
  • BBC Media Action

    Delhi

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

    Rewa, Madhya Pradesh

Other trials in India

About this study

Official title: Impact Evaluation of Maternal Health Information Messaging in India

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.

Read the detailed description

The Johns Hopkins Global mHealth Initiative, Oxford Policy Management, and University of Cape Town proposes supporting BBC Media Action and the Ministry of Health and Family Welfare (MOHFW) to conduct an external evaluation of Mobile Academy (MA) and Kilkari. In the below text, we outline 6 proposed activities which comprise the evaluation, which are planned from mid 2018 to April 2020.

These studies will help inform program modification and scale-up plans, and will help better understand the effects of maternal mobile messaging in India and globally.

  1. Secondary analysis of cross-site trends in key performance indicators (Duration: throughout study): Mobile Academy (MA): We will use system generated data to estimate the proportion of ASHAs who have completed MA training across 12 states. We will additionally aim to understand linkages between ASHA's exposure to the MA training content and performance on MA knowledge assessments. Kilkari: We estimate that Kilkari users will have differing levels of exposure to the program. For example, some women may not be present when the Kilkari calls come and thus miss out on key content. Analyses of system generated data will aim to measure exposure to Kilkari messages by content area (e.g. nutrition, family planning, etc) across 12 states where implementation has occurred to date. As part of this analysis we'll seek to understand reasons why calls are not received, including phones being out of network, changes in SIM cards, etc.
  2. Summative evaluation of Kilkari (Period: April 2018 to December 2019) Objective: To determine the effectiveness of mobile maternal health information messages on key health outcomes in 4 districts of Madhya Pradesh (MP). This objective will be carried out through an individually randomized controlled trial initiated in early 2018. We propose conducting household surveys in all 4 study districts among the cohort of women identified during conception, starting in March 2018. Women identified within the 5-7 month of their pregnancy, who have access to a mobile phone, and consent to participate will be interviewed as part of baseline survey and recruited for participation into Kilkari by 8 months of conception (this is intended to mirror timings observed in Kilkari outreach in other states). Among individuals not randomized to receive messages, we would propose delaying implementation for Kilkari for a 12-month window to allow for evaluation activities to take place and additionally glean information which is anticipated to improve the efficiency of implementation / rollout in other areas.
  3. ASHA Survey Objective: Identify factors underpinning differences Reproductive Maternal Newborn and Child Health (RMNCH) knowledge and motivation among frontline health workers, including exposure to the Mobile Academy training program. As part of the baseline surveys described under activity 2 in MP, we will conduct face to face interviews with all ASHAs (n=1,200) across the four study districts in MP. A sub-sample will also be contacted for a follow-on phone survey a week later, to pilot modules and validate a phone survey tool on knowledge and motivation, which can then be applied to other ASHAs to measure key outcomes as part of MA deployments in other states, including Rajasthan.
  4. Post-natal care phone survey Objective: Measure respectful maternity care (RMC) during childbirth, essential newborn care, and infant feeding practices within 0-3 months postpartum As part of baseline survey activities in MP, we propose additionally identifying women in 1-2 districts who are 0 to 3 months postpartum (n=880). Face to face interviews with postpartum women will provide a forum to measure key infant feeding and essential newborn care outcomes. Phone surveys, a week later, with a subset will help develop a validated phone survey tool for their measurement amongst individuals enrolled into Kilkari.
  5. Qualitative interviews of both Kilkari and MA in MP and Rajasthan Objectives: Mobile Academy
  • Understand stakeholder (ASHA, ASHA supervisor and beneficiary) perceptions of MA, including barriers / facilitators underpinning uptake and completion of MA training and enacting its content, and how it affects interpersonal communication between stakeholders. Kilkari
  • Understand stakeholder (ASHA, ASHA supervisor and beneficiary) perceptions of Kilkari, including different message content areas, barriers / facilitators to the adoption of Kilkari's recommended RMNCH practices and careseeking behaviors
  • Identify barriers / facilitators for pregnancy and birth registration The qualitative research component will complement the summative evaluation and secondary data analysis components. Qualitative research will include in-depth interviews and focus group discussions in both MP and Rajasthan. Differentials in uptake of MA across these settings provides a unique opportunity to understand the characteristics of ASHAs and the larger health systems environment which contribute to MA completion. Among Kilkari beneficiaries, qualitative research can help better understand user perception of content, the extent and mechanism of impact of the messages on health-related knowledge, behavior and relationships.
  1. Economic evaluation of Kilkari Objective: To determine the incremental cost-effectiveness of Kilkari as compared to a null scenario of no messages To estimate the value for money of Kilkari, we will estimate the costs of program to all key stakeholders involved-including BBC Media Action, MOHFW, and end-users. To estimate the effects of the program on health outcomes, we will draw from household survey data at baseline and endline amongst individuals exposed and not exposed to messages. Data on changes in careseeking for antenatal care as well the adoption of practices around breastfeeding and family planning will be inputted into the Lives Saved Tool to generate a measure of lives saved associated with program activities. Lives saved will be used to yield an estimate of the incremental Disability-Adjusted Life Years (DALY) averted and ultimately a cost per DALY averted.
Being tested
Kilkari
Keywords
mobile health, Pregnant and postpartum women, Frontline health workers, India
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03576157
Study groupRoleWhat they receive
KilkariExperimentalPregnant 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.
Receives: Other: Kilkari
ComparisonNo interventionExisting standard of care; no new health messages

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Exclusive breastfeeding

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

    Measured: 0-6 months following delivery

  2. Immediate breastfeeding

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

    Measured: 1 hour following delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2018
  2. Study start7 Jul 2018
  3. Primary completion20 Mar 2020
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
5,095 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03576157
Sponsor's protocol ID
90075552
Status last verified
Sep 2022
First submitted
22 Jun 2018
Last updated
30 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data may be made available upon request to study investigators following the publication of study findings.

Publications

  • 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.

    PubMed 36958740
  • 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.

    PubMed 36931682
  • 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.

    PubMed 35835477
  • 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.

    PubMed 35273055
  • 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.

    PubMed 34312153
  • 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.

    PubMed 32813276
  • 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.

    PubMed 31092278

Questions about this trial

What is this clinical trial studying?

A study testing Kilkari in people with Breast Feeding and Family Planning, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Exclusive breastfeeding (time frame: 0-6 months following delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03576157, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.

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