NCT02726230

Brief Summary

Ananya was funded by BMGF 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 increase maternal and neonatal care and health behaviors, and thus survival. From 2012 to 2014, eight focal districts in western and central Bihar.received Ananya, while 30 districts did not. Data were collected from mothers of infants 0-11 months at baseline and mothers of infants 0-23 months at 2 year follow-up, from comparable public health blocks in Ananya and Control districts to assess Ananya 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 Ananya outcome effects in this quasi experimental study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27,633

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
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Last Updated

April 1, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

March 21, 2016

Last Update Submit

March 27, 2016

Conditions

Outcome Measures

Primary Outcomes (5)

  • Receipt of two or more home visits from an FLW in the final trimester of pregnancy, 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

  • Postnatal care behaviors (4 outcomes)- clean cord care, KMC, delayed bath, initiation of breastfeeding), reported by mothers

    Postnatal care practices \[Nothing applied to cord or umbilicus; Health worker placed child unclothed on mother's chest/abdomen in skin-to-skin contact; First bath delayed by two or more days; Breastfed child within one hour of birth\] assessed via self-report using a single item for each behavior from representative sample of mothers of children aged 0-11 months; items from demographic and health surveys

    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 assesse complementary feeding of infants as reported by mothers of infants aged 0-11 months; items taken from the Demographic and Health Survey

    2 year follow-up

  • Immunizations (4 outcomes)- receipt of DBT1 and DBT3 for infants 6-11 mo; receipt of DPT3 and measles vaccine for children 12-23 months, 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

Study Arms (2)

Ananya Intervention

EXPERIMENTAL

1. Strengthen enumeration and mapping of areas to ensure reach of front line workers (FLWs: auxiliary nurse midwives- ANMs; community health workers- ASHAs; anganwadi workers- AWWs). 2. Convene monthly FLW meetings to build skills and get trained in job kits to increase the quantity and quality of household visits. 3. Train FLWs on communication skills and use of mobile kunji, a job-aid tool, to improve FLWs' communication with households. 4. A mass media campaign inclusive of street theatre, tv and radio, and a mobile van. 5. Community mobilization linking mass media efforts with self-help groups. 6. Quality improvement activities at public health facilities. 7. Facility-based skills training to staff delivering infants to improve quality of care

Behavioral: Ananya

Control Condition

NO INTERVENTION

standard of care public health services in India

Interventions

AnanyaBEHAVIORAL

The Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services.

Ananya Intervention

Eligibility Criteria

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

You may qualify if:

  • Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Abdalla S, Pair E, Mehta K, Ward V, Mahapatra T, Darmstadt GL. Improving the precision of maternal, newborn, and child health impact through geospatial analysis of the association of contextual and programmatic factors with health trends in Bihar, India. J Glob Health. 2022 Nov 23;12:04064. doi: 10.7189/jogh.12.04064.

  • Ward V, Abdalla S, Raheel H, Weng Y, Godfrey A, Dutt P, Mitra R, Sastry P, Chamberlain S, Shannon M, Mehta K, Bentley J, Darmstadt Md GL; Ananya Study Group. Implementing health communication tools at scale: mobile audio messaging and paper-based job aids for front-line workers providing community health education to mothers in Bihar, India. BMJ Glob Health. 2021 Jul;6(Suppl 5):e005538. doi: 10.1136/bmjgh-2021-005538.

  • Darmstadt GL, Weng Y, Pepper KT, Ward VC, Mehta KM, Borkum E, Bentley J, Raheel H, Rangarajan A, Bhattacharya D, Tarigopula UK, Nanda P, Sridharan S, Rotz D, Carmichael SL, Abdalla S, Munar W; Ananya Study Group. Impact of the Ananya program on reproductive, maternal, newborn and child health and nutrition in Bihar, India: early results from a quasi-experimental study. J Glob Health. 2020 Dec;10(2):021002. doi: 10.7189/jogh.10.021002. Epub 2020 Dec 19.

  • Abdalla S, Weng Y, Mehta KM, Mahapatra T, Srikantiah S, Shah H, Ward VC, Pepper KT, Bentley J, Carmichael SL, Creanga A, Wilhelm J, Tarigopula UK, Nanda P, Bhattacharya D, Atmavilas Y, Darmstadt GL; Ananya Study Group. Trends in reproductive, maternal, newborn and child health and nutrition indicators during five years of piloting and scaling-up of Ananya interventions in Bihar, India. J Glob Health. 2020 Dec;10(2):021003. doi: 10.7189/jogh.10.021003.

  • Ward VC, Weng Y, Bentley J, Carmichael SL, Mehta KM, Mahmood W, Pepper KT, Abdalla S, Atmavilas Y, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Bhattacharya D, Nanda P, Tarigopula UK, Shah H, Darmstadt GL; Ananya Study Group. Evaluation of a large-scale reproductive, maternal, newborn and child health and nutrition program in Bihar, India, through an equity lens. J Glob Health. 2020 Dec;10(2):021011. doi: 10.7189/jogh.10.021011. Epub 2020 Dec 19.

  • Ghosh R, Spindler H, Dyer J, Christmas A, Cohen SR, Das A, Sonthalia S, Mahapatra T, Gore A, Shah H, Walker DM. Simulation and team training embedded nurse mentoring programme and improvement in intrapartum and newborn care in a low-resource setting in Bihar, India. J Glob Health. 2020 Dec;10(2):021010. doi: 10.7189/jogh.10.021010. Epub 2020 Dec 19.

  • Creanga AA, Jiwani S, Das A, Mahapatra T, Sonthalia S, Gore A, Kaul S, Srikantiah S, Galavotti C, Shah H. Using a mobile nurse mentoring and training program to address a health workforce capacity crisis in Bihar, India: Impact on essential intrapartum and newborn care practices. J Glob Health. 2020 Dec;10(2):021009. doi: 10.7189/jogh.10.021009.

  • Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward V, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health layering of self-help groups: impacts on reproductive, maternal, newborn and child health and nutrition in Bihar, India. J Glob Health. 2020 Dec;10(2):021007. doi: 10.7189/jogh.10.021007. Epub 2020 Dec 19.

  • Mehta KM, Irani L, Chaudhuri I, Mahapatra T, Schooley J, Srikantiah S, Abdalla S, Ward VC, Carmichael SL, Bentley J, Creanga A, Wilhelm J, Tarigopula UK, Bhattacharya D, Atmavilas Y, Nanda P, Weng Y, Pepper KT, Darmstadt GL; Ananya Study Group. Health impact of self-help groups scaled-up statewide in Bihar, India. J Glob Health. 2020 Dec;10(2):021006. doi: 10.7189/jogh.10.021006. Epub 2020 Dec 19.

  • Ward VC, Raheel H, Weng Y, Mehta KM, Dutt P, Mitra R, Sastry P, Godfrey A, Shannon M, Chamberlain S, Kaimal R, Carmichael SL, Bentley J, Abdalla S, Pepper KT, Mahapatra T, Srikantiah S, Borkum E, Rangarajan A, Sridharan S, Rotz D, Nanda P, Tarigopula UK, Atmavilas Y, Bhattacharya D, Darmstadt GL; Ananya Study Group. Impact of mHealth interventions for reproductive, maternal, newborn and child health and nutrition at scale: BBC Media Action and the Ananya program in Bihar, India. J Glob Health. 2020 Dec;10(2):021005. doi: 10.7189/jogh.10.021005. Epub 2020 Dec 19.

  • Abdalla S, Pair E, Mehta KM, Ward VC, Darmstadt GL. Geospatial variations in trends of reproductive, maternal, newborn and child health and nutrition indicators at block level in Bihar, India, during scale-up of Ananya program interventions. J Glob Health. 2020 Dec;10(2):021004. doi: 10.7189/jogh.10.021004.

Study Officials

  • Yamini Atmavilas

    Bill and Melinda Gates Foundattion

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

March 21, 2016

First Posted

April 1, 2016

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 1, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Data from this study are public and available from the Bill and Melinda Gates Foundation