- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882268
Integrating MIYCN Counseling in Urban Health Services
A Feasibility Study of Integrating Maternal, Infant and Young Child Nutrition (MIYCN) Counseling Services in Urban Maternal, Neonatal and Child Health (MNCH) Services in Bangladesh: A Quasi-experimental Evaluation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Dhaka, Bangladesh
- Data Analysis and Technical Assistance Limited
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
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: MIYCN interventions
8 facilities run by 2 NGOs that will receive intensified MIYCN interventions.
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No Intervention: Comparison facilities
8 facilities run by 2 other NGOs, which will not receive any standardized MIYCN interventions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facility readiness for nutrition services
Time Frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
|
Total standardized scores of resources and staffing available to provide nutrition services at the health facility, with higher scores representing higher readiness.
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15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
|
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Service provider knowledge on topics related to maternal and child nutrition
Time Frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
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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
|
|
Quality of nutrition counseling during ANC by health staff
Time Frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
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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.
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15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
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Quality of nutrition counseling during well-child or sick-child visits by health staff
Time Frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
|
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.
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15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
|
|
Pregnant women's/mother's utilization of and satisfaction with MIYCN services
Time Frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
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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
|
|
Pregnant women's/mother's knowledge of MIYCN topics
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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Total standardized scores of correct answers to questions related to maternal and child nutrition, with higher scores representing higher knowledge.
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16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet diversity among pregnant women
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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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
|
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Maternal consumption of IFA tablets
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
|
The mean number of IFA tablets consumed during pregnancy.
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16 months after baseline in a cross-sectional endline survey scheduled for June 2022
|
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Maternal consumption of calcium tablets
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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The mean number of calcium tablets consumed during pregnancy.
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16 months after baseline in a cross-sectional endline survey scheduled for June 2022
|
|
Early initiation of breastfeeding
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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The proportion of women who initiated breastfeeding within one hour of birth.
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16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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Exclusive breastfeeding among children aged 0-5.9 months
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.
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16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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Age-appropriate complementary feeding of children aged 6-11.9 months
Time Frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Purnima Menon, PhD, IFPRI
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- InternationalFPRI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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