Maternal NutritionNCT03882268
Integrating MIYCN Counseling in Urban Health Services
A study testing MIYCN interventions in people with Maternal Nutrition, run by International Food Policy Research Institute at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Nutrition
- What is being tested?
- MIYCN interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,128 participants
- Where
- 1 siteBangladesh
- Study dates
- 15 Nov 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant women with severe illness or complications
- Mothers with severely ill children
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Maternal Nutrition
- Being tested
- MIYCN interventions
- Keywords
- Urban, Maternal Nutrition, Nutrition Counseling, Behavior change, Infant and young child feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIYCN interventionsBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| MIYCN interventions | Experimental | 8 facilities run by 2 NGOs that will receive intensified MIYCN interventions. Receives: Behavioral: MIYCN interventions |
| Comparison facilities | No intervention | 8 facilities run by 2 other NGOs, which will not receive any standardized MIYCN interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Secondary outcomes (6)
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.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Maternal consumption of IFA tablets
The mean number of IFA tablets consumed during pregnancy.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Maternal consumption of calcium tablets
The mean number of calcium tablets consumed during pregnancy.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Early initiation of breastfeeding
The proportion of women who initiated breastfeeding within one hour of birth.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
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.
Measured: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start15 Nov 2019
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maternal NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Purnima Menon, PhD, Principal investigator, IFPRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882268
- Sponsor's protocol ID
- InternationalFPRI
- Status last verified
- Feb 2022
- First submitted
- 12 Mar 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37354978
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03882268
- Acronym / sponsor ID
- InternationalFPRI
- Conditions
- Maternal Nutrition
- Keywords
- Urban, Maternal Nutrition, Nutrition Counseling, Behavior change, Infant and young child feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,128 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MIYCN interventions | Experimental | Behavioral: MIYCN interventions8 facilities run by 2 NGOs that will receive intensified MIYCN interventions. |
| Comparison facilities | No intervention | –8 facilities run by 2 other NGOs, which will not receive any standardized MIYCN interventions. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant women with severe illness or complications
- Mothers with severely ill children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIYCN interventions1. 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. | Behavioural | MIYCN interventions |
Primary outcome
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.
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
Total standardized scores of correct answers to questions related to maternal and child nutrition, with higher scores represent higher knowledge.
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
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.
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.
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
Total standardized scores of answers to questions related to utilization of and satisfaction with MIYCN services, with higher scores represent higher utilization and satisfaction.
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
Total standardized scores of correct answers to questions related to maternal and child nutrition, with higher scores representing higher knowledge.
6 secondary outcomes
Diet diversity among pregnant women
Time frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Maternal consumption of IFA tablets
Time frame: 16 months after baseline in a cross-sectional endline survey scheduled for June 2022
Maternal consumption of calcium tablets
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 37354978Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purnima Menon, PhD principal investigator
IFPRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIYCN interventions in people with Maternal Nutrition, run by International Food Policy Research Institute at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facility readiness for nutrition services (time frame: 15-16 months after baseline in a cross-sectional endline survey scheduled for May-June 2022). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.