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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03882268
Other study ID # InternationalFPRI
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2019
Est. completion date November 30, 2022

Study information

Verified date February 2022
Source International Food Policy Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will use a quasi-experimental design to examine the feasibility of standardizing MIYCN counseling services in existing health facilities to improve the quality of MIYCN services. The impact of standardized and upgraded services on client utilization, knowledge and behavior will also be measured. 8 NGO-run urban health facilities in Dhaka will receive intensified MIYCN interventions, while another 8 NGO-run urban health facilities will serve as a comparison group. No randomization will take place.


Description:

The primary objectives of the proposed evaluation are to answer the following questions: - Is it feasible to standardize the delivery of MIYCN counseling services in existing urban health facilities? - Can quality of MIYCN counseling service be improved by upgrading and standardizing existing MIYCN counseling service in urban health facilities? - What are the impacts of standardized and upgraded MIYCN counseling service on utilization of MIYCN services and knowledge of clients? The secondary objectives are: - What are the impacts of standardized and upgraded MIYCN counseling service on behaviors of clients including: - Pregnant women: 1) consumption of diversified foods; 2) intake of IFA and calcium supplements during pregnancy - Mothers of children <1 y: age-appropriate infant feeding The study will use a quasi-experimental design, with data collection taking place in three different stages: 1) Baseline data collection to assess comparability of facilities, service quality and client's behaviors, 2) Facility-based endline data collection and 3) Community-based endline survey. The evaluation was originally intended to be a randomized control trial, covering 20 NGO-run urban health facilities under contract with the Urban Primary Health Care Services Delivery Project (UPHCSDP). 10 of the 20 health facilities were randomized to receive the intervention, while the other 10 facilities would serve as the comparison group. Baseline data collection took place in these 20 facilities in October-November 2019. However, the project did not receive approval from UPHCSDP, and interventions were not implemented at the 10 facilities in the treatment group. Instead, A&T partnered with 2 other NGOs in Dhaka whose 8 health facilities also provide services in urban areas but are not affiliated with UPHCSDP. These 8 facilities will receive the intervention. Propensity score matching will be used to select 8 of the original 20 facilities under contract with UPHCSDP to serve as the control group. Baseline data collection in the intervention facilities will take place in February-March 2020. The facility-based end line will take place in May-June 2022, and the community-based endline will take place in June 2022. Data will be collected for the full sample of intervention facilities at baseline (i.e. with the same sample size as at endline), given uncertainty in obtaining government approval to collect endline data from comparison facilities under contract with UPHCSDP. The larger sample from intervention facilities at baseline allows for a shift in evaluation design from quasi-experimental to a pre-post comparison, if the project does not receive government approval. The study will use mixed data collection methods including: 1) facility assessment; 2) provider survey; 3) case observations (namely ANC visits, child visits [both sick child and immunization], and counseling sessions), 4) client interviews and 5) in-depth interview with Program Managers and Field Supervisors.


Recruitment information / eligibility

Status Completed
Enrollment 4128
Est. completion date November 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria: - Pregnant women who are visiting the health facilities for ANC visits (at least twice during her pregnancy, around half of clients) - Mothers with children <12 months of age who are visiting the health facilities for health check-ups or vaccination Exclusion Criteria: - Pregnant women with severe illness or complications - Mothers with severely ill children

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
MIYCN interventions
Capacity building for health providers and nutrition counselors (training on MIYCN SBCC from A&T). Dedicated room for MIYCN counseling at health facilities with standardized layouts, displays of government IYCF logo, and other specifications. Availability of standardized MIYCN-specific BCC materials and job aids. Standardized MIYCN counseling services (counseling on diet diversity and quantity, IFA and calcium supplementation, weight gain monitoring, exclusive and early initiation of breastfeeding, complementary feeding, and water, sanitation and health) provided by a dedicated MIYCN counselor hired by A&T. Dedicated community worker hired by A&T to identify and mobilize beneficiaries needing services in the community (via satellite clinic outreach, distribute MIYCN flyers, and provision of MIYCN education via phone or home visits). Supportive supervision of MIYCN counselors and community workers by program and facility managers, and field supervisors.

Locations

Country Name City State
Bangladesh Data Analysis and Technical Assistance Limited Dhaka

Sponsors (1)

Lead Sponsor Collaborator
International Food Policy Research Institute

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type Measure Description Time frame Safety issue
Primary Facility readiness for nutrition services Total standardized scores of resources and staffing available to provide nutrition services at the health facility, with higher scores representing higher readiness. 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
Primary Service provider knowledge on topics related to maternal and child nutrition Total standardized scores of correct answers to questions related to maternal and child nutrition, with higher scores represent higher knowledge. 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
Primary Quality of nutrition counseling during ANC by health staff Total standardized scores of correct messages on diet diversity and quantity, IFA and calcium supplementation, weight gain monitoring, early initiation of breastfeeding, and water, sanitation and health by health staff during counseling sessions, with higher scores representing higher quality of counseling. 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
Primary Quality of nutrition counseling during well-child or sick-child visits by health staff Total standardized scores of correct messages on exclusive and early initiation of breastfeeding, complementary feeding, and water, sanitation and health provided by health staff during counseling sessions, with higher scores representing higher quality of counseling. 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
Primary Pregnant women's/mother's utilization of and satisfaction with MIYCN services Total standardized scores of answers to questions related to utilization of and satisfaction with MIYCN services, with higher scores represent higher utilization and satisfaction. 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
Primary Pregnant women's/mother's knowledge of MIYCN topics Total standardized scores of correct answers to questions related to maternal and child nutrition, with higher scores representing higher knowledge. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Diet diversity among pregnant women The proportion of pregnant women who consumed foods from 5 or more food groups on the day preceding the interview. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Maternal consumption of IFA tablets The mean number of IFA tablets consumed during pregnancy. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Maternal consumption of calcium tablets The mean number of calcium tablets consumed during pregnancy. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Early initiation of breastfeeding The proportion of women who initiated breastfeeding within one hour of birth. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Exclusive breastfeeding among children aged 0-5.9 months The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary Age-appropriate complementary feeding of children aged 6-11.9 months The proportion of children aged 6-11.9 months who received foods from 4 or more food groups and fed the appropriate number of times/meals on the day preceding the interview. 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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