Clinical trial NCT03882268: Integrating MIYCN Counseling in Urban Health Services
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Nutrition
Keywords: Urban
Maternal Nutrition
Nutrition Counseling
Behavior change
Infant and young child feeding
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 4128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. No randomization will take place. Health workers and clients at these facilities will be participants in the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Facility readiness for nutrition services
timeFrame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
measure: Service provider knowledge on topics related to maternal and child nutrition
timeFrame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
measure: Quality of nutrition counseling during ANC by health staff
timeFrame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
measure: Quality of nutrition counseling during well-child or sick-child visits by health staff
timeFrame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
measure: Pregnant women's/mother's utilization of and satisfaction with MIYCN services
timeFrame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022
measure: Pregnant women's/mother's knowledge of MIYCN topics
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary outcomes:
measure: Diet diversity among pregnant women
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
measure: Maternal consumption of IFA tablets
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
measure: Maternal consumption of calcium tablets
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
measure: Early initiation of breastfeeding
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
measure: Exclusive breastfeeding among children aged 0-5.9 months
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
measure: Age-appropriate complementary feeding of children aged 6-11.9 months
timeFrame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Data Analysis and Technical Assistance Limited
Study officials:
affiliation: IFPRI
name: Purnima Menon, PhD
role: PRINCIPAL_INVESTIGATOR
References: