NCT03882268

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,128

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

September 26, 2023

Status Verified

February 1, 2022

Enrollment Period

2.6 years

First QC Date

March 12, 2019

Last Update Submit

September 25, 2023

Conditions

Keywords

UrbanMaternal NutritionNutrition CounselingBehavior changeInfant and young child feeding

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Diet diversity among pregnant women

    16 months after baseline in a cross-sectional endline survey scheduled for June 2022

  • Maternal consumption of IFA tablets

    16 months after baseline in a cross-sectional endline survey scheduled for June 2022

  • Maternal consumption of calcium tablets

    16 months after baseline in a cross-sectional endline survey scheduled for June 2022

  • Early initiation of breastfeeding

    16 months after baseline in a cross-sectional endline survey scheduled for June 2022

  • Exclusive breastfeeding among children aged 0-5.9 months

    16 months after baseline in a cross-sectional endline survey scheduled for June 2022

  • +1 more secondary outcomes

Study Arms (2)

MIYCN interventions

EXPERIMENTAL

8 facilities run by 2 NGOs that will receive intensified MIYCN interventions.

Behavioral: MIYCN interventions

Comparison facilities

NO INTERVENTION

8 facilities run by 2 other NGOs, which will not receive any standardized MIYCN interventions.

Interventions

1. Capacity building for health providers and nutrition counselors (training on MIYCN SBCC from A\&T). 2. Dedicated room for MIYCN counseling at health facilities with standardized layouts, displays of government IYCF logo, and other specifications. 3. Availability of standardized MIYCN-specific BCC materials and job aids. 4. 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. 5. 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). 6. Supportive supervision of MIYCN counselors and community workers by program and facility managers, and field supervisors.

MIYCN interventions

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women with severe illness or complications
  • Mothers with severely ill children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Data Analysis and Technical Assistance Limited

Dhaka, Bangladesh

Location

Related Publications (1)

  • Nguyen PH, Sununtnasuk C, Christopher A, Ash D, Ireen S, Kabir R, Mahmud Z, Ali M, Forissier T, Escobar-DeMarco J, Frongillo EA, Menon P. Strengthening Nutrition Interventions during Antenatal Care Improved Maternal Dietary Diversity and Child Feeding Practices in Urban Bangladesh: Results of a Quasi-Experimental Evaluation Study. J Nutr. 2023 Oct;153(10):3068-3082. doi: 10.1016/j.tjnut.2023.06.023. Epub 2023 Jun 23.

Study Officials

  • Purnima Menon, PhD

    IFPRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 20, 2019

Study Start

November 15, 2019

Primary Completion

June 30, 2022

Study Completion

November 30, 2022

Last Updated

September 26, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations