Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03561012
Other study ID # TBGI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2012
Est. completion date November 30, 2014

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 3581
Est. completion date November 30, 2014
Est. primary completion date November 30, 2014
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - Mothers of infants 0-12 months residing in the catchment area of the subcenters (public health facilities) Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Team-Based Goals and Incentives
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).
Other:
Control Condition
Standard of care

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Stanford University Bill and Melinda Gates Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Received 90 IFA tablets Assessed via self-report from representative sample of mothers of children aged 0-11 months. 2.5 year follow-up
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1