HealthyNCT03561012
Team-Based Goals and Incentives for Community-Based Health Workers to Promote Maternal and Child Health in Bihar, India
A study testing Team-Based Goals and Incentives in people with Healthy, run by Stanford University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women only
- Conditions the study is for
- Healthy
- What is being tested?
- Team-Based Goals and Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,581 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Nov 2014
- 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 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mothers of infants 0-12 months residing in the catchment area of the subcenters (public health facilities)
Who cannot join
- -
About this study
Official title: Use of Team-Based Goals and Incentives to Improve the Performance of Community-Based Health Workers in Promoting Reproductive, Maternal, Newborn and Child Health and Nutrition Behaviors in Bihar, India: A Cluster Randomized Trial
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.
- Conditions
- Healthy
- Being tested
- Team-Based Goals and Incentives, Control Condition
- Keywords
- health, nutrition, pregnancy, infant, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-Based Goals and IncentivesBehavioural
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).
Control ConditionOther
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Behavioral: Team-Based Goals and Incentives |
| Control Arm | Active comparator | Not described Receives: Other: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 2 antenatal home visits in final trimester
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2.5 year follow-up
Received 90 IFA tablets
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2.5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start1 Jan 2012
- Primary completion30 Nov 2014
- Study completion30 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Gary Darmstadt, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561012
- Sponsor's protocol ID
- TBGI
- Status last verified
- Apr 2023
- First submitted
- 6 Jun 2018
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Team-Based Goals and Incentives to Improve the Performance of Community-Based Health Workers in Promoting Reproductive, Maternal, Newborn and Child Health and Nutrition Behaviors in Bihar, India: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03561012
- Acronym / sponsor ID
- TBGI
- Conditions
- Healthy
- Keywords
- health, nutrition, pregnancy, infant, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,581 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Nov 2014 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Team-Based Goals and Incentives |
| Control Arm | Active comparator | Other: Control Condition |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Mothers of infants 0-12 months residing in the catchment area of the subcenters (public health facilities)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-Based Goals and IncentivesThe 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). | Behavioural | Intervention arm |
| Control ConditionStandard of care | Other | Control Arm |
Primary outcome
At least 2 antenatal home visits in final trimester
Time frame: Up to 2.5 years
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
At least one home visit within 24 hours of delivery, among women who had a home delivery
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
At least one home visit within 1 week of delivery
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Complementary feeding home visit for women with infant 6-11 months old
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Postpartum family planning home visits
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Obtained phone number for delivery (Frontline worker's (FLW) number, number for private vehicle, number for ambulance, any of the above)
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Received 90 IFA tablets
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Immediate breastfeeding (within 1 hour of delivery)
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Nothing applied to the cord after cutting
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Infant age 6-11 months old ate cereal-based meal in previous day
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 6-11 months.
Current use of any modern method of contraception:
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 0-11 months.
Child age 6-11 months old received DPT3 vaccination
Time frame: 2.5 year follow-up
Assessed via self-report from representative sample of mothers of children aged 6-11 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Team-Based Goals and Incentives in people with Healthy, run by Stanford University.
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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
At least 2 antenatal home visits in final trimester (time frame: Up to 2.5 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.