NCT03561012

Brief Summary

This study is designed to evaluate the impact of team-based goals and performance-based incentives for 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 implemented from 2012 to 2014. Health sub-centers in the catchment areas of five blocks (sub-districts) of the district of Bengusarai were randomly assigned to treatment or control arms (38 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 2.5-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 TBGI 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 \[TBGI intervention + Ananya\] versus \[Ananya alone\]. The Ananya program was developed and implemented via a partnership of BMGF 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
3,581

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2014

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

June 6, 2018

Last Update Submit

April 17, 2023

Conditions

Keywords

healthnutritionpregnancyinfantchild

Outcome Measures

Primary Outcomes (12)

  • At least 2 antenatal home visits in final trimester

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

    Up to 2.5 years

  • At least one home visit within 24 hours of delivery, among women who had a home delivery

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

    2.5 year follow-up

  • At least one home visit within 1 week of delivery

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

    2.5 year follow-up

  • Complementary feeding home visit for women with infant 6-11 months old

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

    2.5 year follow-up

  • Postpartum family planning home visits

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

    2.5 year follow-up

  • Obtained phone number for delivery (Frontline worker's (FLW) number, number for private vehicle, number for ambulance, any of the above)

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

    2.5 year follow-up

  • Received 90 IFA tablets

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

    2.5 year follow-up

  • Immediate breastfeeding (within 1 hour of delivery)

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

    2.5 year follow-up

  • Nothing applied to the cord after cutting

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

    2.5 year follow-up

  • Infant age 6-11 months old ate cereal-based meal in previous day

    Assessed via self-report from representative sample of mothers of children aged 6-11 months.

    2.5 year follow-up

  • Current use of any modern method of contraception:

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

    2.5 year follow-up

  • Child age 6-11 months old received DPT3 vaccination

    Assessed via self-report from representative sample of mothers of children aged 6-11 months.

    2.5 year follow-up

Study Arms (2)

Intervention arm

EXPERIMENTAL
Behavioral: Team-Based Goals and Incentives

Control Arm

ACTIVE COMPARATOR
Other: Control Condition

Interventions

The intervention included 3 main components. 1) The intervention fostered a sense of team collective responsibility and solidarity (TEAM) by emphasizing the value of teamwork and front-line community health workers (FLWs) reciting a pledge at meetings to serve beneficiaries. 2) To establish goals and coverage targets related to maternal and child health outcomes (GOALs), 7 targets were identified related to delivery preparations, newborn care, exclusive breastfeeding, and family planning. 3) Small non-cash incentives were awarded to FLWs each quarter if their team met greater than 70% of the collective subcenter goals; incentives were most common cookware products (e.g., dish, cooking vessel, steamer). Non-cash incentives also included a certificate of recognition for teams that met their targets in all quarters (INCENTIVES). In the areas of the intervention and control arms, the Ananya program was also underway (see Brief Summary of the project).

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 (public health facilities)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

June 6, 2018

First Posted

June 19, 2018

Study Start

January 1, 2012

Primary Completion

November 30, 2014

Study Completion

November 30, 2014

Last Updated

April 19, 2023

Record last verified: 2023-04