Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521151
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-02
Brief Title:
The Effect of Audio Based Nutrition Education on Dietary Intake Practice and Egg-based Diet Intervention on Nutrient Adequacy and Gestational Weight Gain Among Pregnant Women and Newborns Birth Weights in the North Sidama Zone Ethiopia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Audio Based Nutrition Education on Dietary Intake Practice and Egg-based Diet Intervention on Nutrient Adequacy and Gestational Weight Gain Among Pregnant Women and Newborns Birth Weights in the North Sidama Zone Ethiopia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
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:
Background Inadequate intake and utilization of nutrients during pregnancy is associated with inadequate nutrient adequacy and it has central implications on subsequent suboptimal weight gain and has an increased risk on low birth weight Likewise majority of Ethiopian pregnant women have inadequate nutrient intakes These may be due to their poor dietary habits Nutrition education is well-established intervention to enhance optimal dietary practices and is crucial to design appropriate diet interventions like multiple micronutrient and protein-energy supplements to optimize pregnancy outcomes
However in this country integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied Therefore this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice nutrient adequacy and gestational weight gain among pregnant women and newborns birth weight in North Sidama Zone
Materials and methods These studies will employee mixed study designs sequentially to address each specific objective Baseline survey A mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of North Sidama Zone in February 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women
Following the baseline survey four-arm cluster- randomized controlled trial cRCT will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice nutrient adequacy and gestational weight gain among pregnant women and birth weight from March to August 2024 A total of 300 pregnant women will be selected randomly from participants of the baseline survey and enrolled in four arms in a 1111 allocation ratios A multi-level mixed-effect logistic regression model will be used for quantitative data analysis and a paired and independent t-test will be employed to measure the mean change in dietary intake practice gestational weight gain and nutrient density between intervention and control groups The qualitative data will be analyzed using Atlas-Ti software according to the inductive thematic content analysis approach
Budget and work plan For this study 1102200 ETB will be required The study will be funded by Norad Project Hawassa University Sidama Regional Government and other possible grants in future The study period will be March to August 2024
However in this country integration of nutrition education with intervention of essential nutrients during pregnancy is not well studied Therefore this study is designed to measure the effect of nutrition education and egg-based diet interventions on dietary intake practice nutrient adequacy and gestational weight gain among pregnant women and newborns birth weight in North Sidama Zone
Materials and methods These studies will employee mixed study designs sequentially to address each specific objective Baseline survey A mixed method comprising community-based cross-sectional quantitative study complemented with a descriptive qualitative study that will be conducted in three woredas of North Sidama Zone in February 2024 to assess barriers and facilitators on the intake of adequate nutrients among pregnant women
Following the baseline survey four-arm cluster- randomized controlled trial cRCT will be conducted to evaluate the effectiveness of nutrition education and egg-based diet interventions on dietary intake practice nutrient adequacy and gestational weight gain among pregnant women and birth weight from March to August 2024 A total of 300 pregnant women will be selected randomly from participants of the baseline survey and enrolled in four arms in a 1111 allocation ratios A multi-level mixed-effect logistic regression model will be used for quantitative data analysis and a paired and independent t-test will be employed to measure the mean change in dietary intake practice gestational weight gain and nutrient density between intervention and control groups The qualitative data will be analyzed using Atlas-Ti software according to the inductive thematic content analysis approach
Budget and work plan For this study 1102200 ETB will be required The study will be funded by Norad Project Hawassa University Sidama Regional Government and other possible grants in future The study period will be March to August 2024
Detailed Description:
None
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