Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867836
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-04-24
Brief Title:
Multiple Micronutrient Supplementation vs Iron and Folic Acid Among Pregnant Women in Cambodia
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Trial of Adherence and Acceptance of Multiple Micronutrient Supplementation MMS vs Iron and Folic Acid IFA Among Pregnant Women and Health System Enablers and Constraints Related to MMS in Cambodia
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMS-Cambodia
Brief Summary:
Iron and folic acid IFA supplements are currently provided to Cambodian women during pregnancy However recent research has showed benefit of a multiple micronutrient supplement MMS over just IFA alone on several outcomes of perinatal and infant health The Ministry of Health in Cambodia has proposed a transition from IFA to MMS but would like to collect some formative research on this first to assess acceptability and adherence to MMS over IFA and help guide key messaging packaging and practices to guide the transition in Cambodia
Detailed Description:
Antenatal multiple micronutrient supplementation MMS is a potentially cost-effective scalable approach that can contribute to addressing the persistent challenge of maternal undernutrition reducing low birth weight reducing small-for-gestational age births and potentially reducing preterm birth A 2019 independent patient IDP meta-analysis indicates MMS decreased mortality for female neonates and provided greater reductions in the risk of low birthweight and preterm birth for infants born to undernourished and anemic women The 2019 Cochrane Review compared the effects of MMS to iron folic acid IFA supplementation in another review and meta-analysis and found MMS supplementation was associated with reduced small-for-gestational age births Operationalizing MMS interventions in different country contexts is urgently needed to improve the health of mothers and children However guidelines on antenatal MMS supplementation have yet to be widely adopted into national policies in part because the WHO guidelines do not reflect recent evidence
Helen Keller Intl with support from Vitamin Angels conducted a landscape analysis of antenatal MMS supplementation in Cambodia to supportive or potentially supportive stakeholders to accelerate MMS uptake and use in Cambodia During a stakeholder consultation help in September 2021 workshop participants concluded it is an appropriate time to consider the transition from iron folic acid supplementation IFA to MMS supplementation Following this consultation a multi-stakeholder Steering Committee was formed consisting of technical and government representatives from a range of disciplines to oversee and support this transition
The landscape analysis revealed that key Cambodian stakeholders are open to exploring the feasibility of a transition from IFA to MMS supplementation for pregnant women and identified key operational and implementation research priorities to inform the transition process One of those questions relates to the acceptability by pregnant women of MMS in terms of packaging color ease of consumption taste and overall liking
The landscape analysis also highlighted the need to assess the adherence of MMS vs IFA supplementation WHO recommends that all pregnant women receive a standard dose of 30-60 mg iron and 400 µg folic acid beginning as soon as possible during pregnancy Ideally women should receive IFA no later than the first trimester of pregnancy which means taking 180 tablets before delivery It is important to note that many countries including Cambodia aim for women to receive 90 or more tablets during pregnancy Currently in Cambodia the government is distributing 90 tablets of IFA to pregnant women attending public antenatal care services Thus to transition from 90 tablets of IFA to 180 tablets is not as easy as a pill switch To ensure pregnant women can receive the full benefits from MMS supplementation transitioning from IFA to MMS will require pregnant women to come into ANC during their first trimester and adhere to the recommended 180 tablets of MMS throughout their pregnancy
To date there are no published studies or documentation from Cambodia on pregnant womens acceptability of MMS supplements or adherence to a 180-dosage regimen of MMS A 2011 study in two provinces in Cambodia found access to antenatal care ANC the number of supplements provided and ANC attendance were the strongest determinants for adherence to IFA supplementation Another analysis in Cambodia found the primary reasons for not taking the WHO recommended number of 180 IFA doses WHO 2012 were starting ANC after the 1st trimester and not attending all recommended ANC visits In Nepal researchers have found knowledge about preventable conditions and benefits perceived barriers social support and perceived severity of not taking the supplement predicted IFA compliance while other also found forgetting to take the supplements was a barrier In a study from Vietnam determinants of adherence to either folic acid IFA or MMS supplementation were socioeconomic status ethnicity occupation and parity as well as increased contact with health workers Acceptability studies which included MMS supplementation have identified organoleptic properties perceived benefits and fears or perceived negative effects as influential factors on acceptance and utilization
Following the landscape analysis Vitamin Angels and Helen Keller co-hosted with the Ministry of Health MoH a Consensus Building Stakeholder Workshop Workshop participants recommended conducting a pilot test to engage with the pregnant women who are going to be consuming the product as well as with the health care actors who will be involved in product delivery Following the workshop the MoH formed an MMS Steering Committee comprised of many key stakeholders within the MoH United Nations and civil society The MMS Steering Committee will review the implementation research protocol provide guidance and also meet quarterly to review implementation progress and feedback on development of health provider counseling materials and other strategic behavioral change materials
Assessment of the acceptability and feasibility of a new intervention should be done with end users prior to implementation especially when the strategy requires possible changes in care processes Determining the acceptability of MMS supplements with pregnant women will enhance understanding of barriers to implementation and help to develop an MMS supplementation scale-up strategy that is feasible and cost-effective Implementation strategies will need to consider a host of drivers that influence acceptability and adherence including MMS product availability affordability and acceptability as well as improvements to health seeking behaviors during pregnancy Determining non-inferiority of adherence is also critical when introducing a new supplement Given the dearth of studies and knowledge around MMS supplementation in Cambodia Helen Keller and Vitamin Angels propose formative and implementation research to identify factors influencing adherence to antenatal supplementation to effectively inform an MMS supplementation strategy and ANC service delivery
Rationale for the Study MMS supplements are a new product for pregnant women and health providers in Cambodia As it is intended to replace IFA MMS supplementation uptake requires careful introduction and transition to ensure optimal supplement acceptability and compliance without which improving maternal nutrition may remain a challenge As others have suggested that transitioning to MMS therefore requires a formative research phase to inform programming and service delivery Specifically testing product acceptability labeling packaging health worker capacity building strategies and behavioral change messaging to promote daily use among Cambodian pregnant women is important before fully transitioning to and scaling up MMS supplementation Furthermore concerns expressed by host-country stakeholders question the impact on ANC use ensuring at least four visits if MMS is provided in a large quantity ie 90 or 180 tablets to pregnant women need to be explored
Aim and Objectives The aim of this study is to assess factors that influence optimal MMS consumption defined as 180 tablets during pregnancy and provide recommendations to the MoH MMS Steering Committee to effectively transition to distribution of 180 tablets of MMS supplements as part of routine ANC services Specific recommendations generated by this study will be related to product acceptability packaging labeling training needs behavioral change messaging adherence and best ways to integrate MMS within ANC services Results of this adherence research are intended to be used by the MoH and the MMS Steering Committee
This study has the following objectives
1 Assess acceptability of IFA and MMS supplements
2 Assess adherence to recommended IFA and MMS supplementation
3 Assess non-inferiority of MMS compared to IFA supplementation
4 Assess impact of pill quantity provided at one time on ANC attendance
5 Evaluate factors that influence adherence behavior
6 Develop recommendations for product marketing and service delivery to encourage adherence to MMS supplementation
Helen Keller Intl with support from Vitamin Angels conducted a landscape analysis of antenatal MMS supplementation in Cambodia to supportive or potentially supportive stakeholders to accelerate MMS uptake and use in Cambodia During a stakeholder consultation help in September 2021 workshop participants concluded it is an appropriate time to consider the transition from iron folic acid supplementation IFA to MMS supplementation Following this consultation a multi-stakeholder Steering Committee was formed consisting of technical and government representatives from a range of disciplines to oversee and support this transition
The landscape analysis revealed that key Cambodian stakeholders are open to exploring the feasibility of a transition from IFA to MMS supplementation for pregnant women and identified key operational and implementation research priorities to inform the transition process One of those questions relates to the acceptability by pregnant women of MMS in terms of packaging color ease of consumption taste and overall liking
The landscape analysis also highlighted the need to assess the adherence of MMS vs IFA supplementation WHO recommends that all pregnant women receive a standard dose of 30-60 mg iron and 400 µg folic acid beginning as soon as possible during pregnancy Ideally women should receive IFA no later than the first trimester of pregnancy which means taking 180 tablets before delivery It is important to note that many countries including Cambodia aim for women to receive 90 or more tablets during pregnancy Currently in Cambodia the government is distributing 90 tablets of IFA to pregnant women attending public antenatal care services Thus to transition from 90 tablets of IFA to 180 tablets is not as easy as a pill switch To ensure pregnant women can receive the full benefits from MMS supplementation transitioning from IFA to MMS will require pregnant women to come into ANC during their first trimester and adhere to the recommended 180 tablets of MMS throughout their pregnancy
To date there are no published studies or documentation from Cambodia on pregnant womens acceptability of MMS supplements or adherence to a 180-dosage regimen of MMS A 2011 study in two provinces in Cambodia found access to antenatal care ANC the number of supplements provided and ANC attendance were the strongest determinants for adherence to IFA supplementation Another analysis in Cambodia found the primary reasons for not taking the WHO recommended number of 180 IFA doses WHO 2012 were starting ANC after the 1st trimester and not attending all recommended ANC visits In Nepal researchers have found knowledge about preventable conditions and benefits perceived barriers social support and perceived severity of not taking the supplement predicted IFA compliance while other also found forgetting to take the supplements was a barrier In a study from Vietnam determinants of adherence to either folic acid IFA or MMS supplementation were socioeconomic status ethnicity occupation and parity as well as increased contact with health workers Acceptability studies which included MMS supplementation have identified organoleptic properties perceived benefits and fears or perceived negative effects as influential factors on acceptance and utilization
Following the landscape analysis Vitamin Angels and Helen Keller co-hosted with the Ministry of Health MoH a Consensus Building Stakeholder Workshop Workshop participants recommended conducting a pilot test to engage with the pregnant women who are going to be consuming the product as well as with the health care actors who will be involved in product delivery Following the workshop the MoH formed an MMS Steering Committee comprised of many key stakeholders within the MoH United Nations and civil society The MMS Steering Committee will review the implementation research protocol provide guidance and also meet quarterly to review implementation progress and feedback on development of health provider counseling materials and other strategic behavioral change materials
Assessment of the acceptability and feasibility of a new intervention should be done with end users prior to implementation especially when the strategy requires possible changes in care processes Determining the acceptability of MMS supplements with pregnant women will enhance understanding of barriers to implementation and help to develop an MMS supplementation scale-up strategy that is feasible and cost-effective Implementation strategies will need to consider a host of drivers that influence acceptability and adherence including MMS product availability affordability and acceptability as well as improvements to health seeking behaviors during pregnancy Determining non-inferiority of adherence is also critical when introducing a new supplement Given the dearth of studies and knowledge around MMS supplementation in Cambodia Helen Keller and Vitamin Angels propose formative and implementation research to identify factors influencing adherence to antenatal supplementation to effectively inform an MMS supplementation strategy and ANC service delivery
Rationale for the Study MMS supplements are a new product for pregnant women and health providers in Cambodia As it is intended to replace IFA MMS supplementation uptake requires careful introduction and transition to ensure optimal supplement acceptability and compliance without which improving maternal nutrition may remain a challenge As others have suggested that transitioning to MMS therefore requires a formative research phase to inform programming and service delivery Specifically testing product acceptability labeling packaging health worker capacity building strategies and behavioral change messaging to promote daily use among Cambodian pregnant women is important before fully transitioning to and scaling up MMS supplementation Furthermore concerns expressed by host-country stakeholders question the impact on ANC use ensuring at least four visits if MMS is provided in a large quantity ie 90 or 180 tablets to pregnant women need to be explored
Aim and Objectives The aim of this study is to assess factors that influence optimal MMS consumption defined as 180 tablets during pregnancy and provide recommendations to the MoH MMS Steering Committee to effectively transition to distribution of 180 tablets of MMS supplements as part of routine ANC services Specific recommendations generated by this study will be related to product acceptability packaging labeling training needs behavioral change messaging adherence and best ways to integrate MMS within ANC services Results of this adherence research are intended to be used by the MoH and the MMS Steering Committee
This study has the following objectives
1 Assess acceptability of IFA and MMS supplements
2 Assess adherence to recommended IFA and MMS supplementation
3 Assess non-inferiority of MMS compared to IFA supplementation
4 Assess impact of pill quantity provided at one time on ANC attendance
5 Evaluate factors that influence adherence behavior
6 Develop recommendations for product marketing and service delivery to encourage adherence to MMS supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None