- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02726230
Bihar Family Health Initiative (Ananya)
March 27, 2016 updated by: Anita Raj, University of California, San Diego
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
27633
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Mothers of infants 0-23 months residing in the catchment area of the subcenters (public health facilities) included in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ananya Intervention
|
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.
|
No Intervention: Control Condition
standard of care public health services in India
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Receipt of two or more home visits from an FLW in the final trimester of pregnancy, using maternal survey response
Time Frame: 2 year follow up
|
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
Time Frame: 2-year follow-up
|
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
Time Frame: 2 year follow-up
|
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
Time Frame: 2 year follow-up
|
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
Time Frame: 2 year follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Yamini Atmavilas, Bill and Melinda Gates Foundattion
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
March 21, 2016
First Submitted That Met QC Criteria
March 27, 2016
First Posted (Estimate)
April 1, 2016
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 27, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- BMGF#22539
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data from this study are public and available from the Bill and Melinda Gates Foundation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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