Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594419
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Healthy Baby Healthy Mother Toolkit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of the Healthy Mother Healthy Baby Toolkit for Maternal and Child Nutrition in Ethiopia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the research is to test whether integrating a mother-baby nutrition toolkit into routine antenatal care service can improve maternal and infant nutrition in Amhara Ethiopia
Detailed Description:
The high burden of undernutrition through the critical first 1000 days persists in Ethiopia Studies have indicated that approximately 1 in 4 women of reproductive age in Ethiopia are underweight 17 of babies are born at low birth weight and nearly 50 of children are stunted by age 2 Inadequate diets of pregnant and breastfeeding women both suboptimal quality and quantity are a key contributor to maternal and infant undernutrition in Ethiopia
The National Nutrition Strategy of Ethiopia adopted in 2008 recommends one additional meal per day to support healthy pregnancy and two extra meals per day to support lactation US Agency for International Development USAID 2008
Using the Health Belief Model for behavior change the study team developed and has tested in other contexts a Healthy Baby Toolkit HBT designed to serve as a cue to action to improve maternal and family self-efficacy in providing mothers and their babies with adequate nutrition The toolkit has previously been tested in India Kenya Malawi and Ethiopia where it has demonstrated acceptability and feasibility and demonstrated improvement in the diets of children between 6-23 months This new trial aims to understand the added health benefits of introducing the toolkit to mothers during pregnancy and the early postpartum period when crucial child growth and development trajectories are established
The study will evaluate the benefits of HBT on maternal nutrition and infant growth especially during the first 500 days pregnancy and first 6 months of life It will also assess strategies for facility and community-based delivery of the toolkit for future rollout and scaling up Findings from this study will create an evidence base for effective counseling strategies and support advocacy efforts to integrate the toolkit into routine nutrition education and counseling programs in Ethiopia
The National Nutrition Strategy of Ethiopia adopted in 2008 recommends one additional meal per day to support healthy pregnancy and two extra meals per day to support lactation US Agency for International Development USAID 2008
Using the Health Belief Model for behavior change the study team developed and has tested in other contexts a Healthy Baby Toolkit HBT designed to serve as a cue to action to improve maternal and family self-efficacy in providing mothers and their babies with adequate nutrition The toolkit has previously been tested in India Kenya Malawi and Ethiopia where it has demonstrated acceptability and feasibility and demonstrated improvement in the diets of children between 6-23 months This new trial aims to understand the added health benefits of introducing the toolkit to mothers during pregnancy and the early postpartum period when crucial child growth and development trajectories are established
The study will evaluate the benefits of HBT on maternal nutrition and infant growth especially during the first 500 days pregnancy and first 6 months of life It will also assess strategies for facility and community-based delivery of the toolkit for future rollout and scaling up Findings from this study will create an evidence base for effective counseling strategies and support advocacy efforts to integrate the toolkit into routine nutrition education and counseling programs in Ethiopia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None