NCT03406221

Brief Summary

This study is designed to evaluate the impact of use of mobile technology by community-based health workers on health-promoting behaviors among women related to reproductive, maternal, newborn and child health and nutrition in Bihar, India. The intervention was funded by the Bill and Melinda Gates Foundation (BMGF) and in collaboration with CARE was implemented from 2012 to 2014. Health sub-centers in the catchment areas of four blocks (sub-districts) of the district of Saharsa were randomly assigned to treatment or control arms (35 sub-centers were assigned to each). Data were collected in the Intervention and Control areas from mothers of infants 0-12 months at baseline and at 2-year follow-up, to assess the intervention's effects on quality and quantity of FLW home visits, postnatal health behaviors, and among older infants/toddlers, complementary feeding and vaccination. Difference in difference analyses were used to assess outcome effects in this quasi experimental study. The ICT-CCS intervention was implemented in areas where the BMGF-funded Ananya program (official title: Bihar Family Health Initiative) was also being implemented. Thus, the impact is of the \[ICT-CCS intervention + Ananya\] versus \[Ananya alone\]. The Ananya program was developed and implemented via a partnership of BMGF, CARE, and the Government of Bihar. The ultimate purpose of Ananya was to reduce maternal, newborn, and child mortality; fertility; and child undernutrition in Bihar, India. Ananya involved multi-level interventions designed to build front line health worker (FLW) capacities and reach to communities and households, as well as to strengthen public health facilities and quality of care to improve maternal and neonatal care and health behaviors, and thus survival. It was implemented from 2012 to 2014. Eight focal districts in western and central Bihar received Ananya, while 30 districts did not.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
3,112

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

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

January 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

October 23, 2017

Last Update Submit

April 17, 2023

Conditions

Outcome Measures

Primary Outcomes (13)

  • Receipt of two or more home visits from an FLW in the final trimester of pregnancy and delivery at a facility (versus home birth), using maternal survey response

    Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey

    2 year follow-up

  • Receipt of any postnatal home visits from an FLW (in the first 24 hours at home after delivery and in first month following delivery), using maternal survey response

    Assessed via self-report from representative sample of mothers of children aged 0-11 months; items created for Ananya Survey.

    2 year follow-up

  • Any complementary feeding of solid or semisolid food for infants aged 6-11 months, using maternal survey response

    A survey item was used to assess complementary feeding of infants as reported by mothers of infants aged 0-11 months; items created for Ananya Survey.

    2 year follow-up

  • Immunizations

    Receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months; maternal receipt of at least 2 tetanus vaccines using immunization cards or maternal self-report if not card. Data from immunization cards or from self-reports when women did not have cards; approximately 50-60% of participants did not have immunization cards

    2 year follow-up

  • Receipt of iron-folic acid tablets by month 4 and consumption of at least 90 tablets, using maternal survey response

    Assessed via self-report from representative sample of mothers of children aged 0-11 months; item created for Ananya Survey.

    2 year follow-up

  • Clean Cord Care

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Kangaroo Mother Care (skin to skin care)

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Delayed Bath

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Initiation of Breastfeeding

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Nothing applied to cord or umbilicus

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • First bath delayed by two or more days

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

  • Breastfed child within one hour of birth

    Assessed via self-report from representative sample of mothers of children aged 0-11 months

    2 year follow-up

Study Arms (2)

Intervention arm

EXPERIMENTAL
Behavioral: Information Communication Technology Continuum of Care Service

Control Arm

ACTIVE COMPARATOR
Other: Control Condition

Interventions

Mobile phones were made available to community health workers in the intervention arms that integrated a comprehensive set of functions to assist them in their duties, including registration and tracking of beneficiaries, automated scheduling of home visits, provision of health information through videos, guided protocols for conducting home visits through checklists, a feature to track child immunizations, and supervisory tools.

Intervention arm

Standard of care

Control Arm

Eligibility Criteria

Age15 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of infants 0-12 months residing in the catchment area of the subcenters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Carmichael SL, Mehta K, Raheel H, Srikantiah S, Chaudhuri I, Trehan S, Mohanty S, Borkum E, Mahapatra T, Weng Y, Kaimal R, Sivasankaran A, Sridharan S, Rotz D, Tarigopula UK, Bhattacharya D, Atmavilas Y, Munar W, Rangarajan A, Darmstadt GL; Ananya Study Group. Effects of team-based goals and non-monetary incentives on front-line health worker performance and maternal health behaviours: a cluster randomised controlled trial in Bihar, India. BMJ Glob Health. 2019 Aug 26;4(4):e001146. doi: 10.1136/bmjgh-2018-001146. eCollection 2019.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Dean for Maternal and Child Health

Study Record Dates

First Submitted

October 23, 2017

First Posted

January 23, 2018

Study Start

January 1, 2012

Primary Completion

August 31, 2014

Study Completion

August 31, 2014

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share