Pregnancy Clinical Trial
Official title:
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
This study evaluates the intervention of Nut Fish based food, micro nutrients supplementation and pregnancy class to improve maternal and birth outcome. This is cluster randomized trial with two arms. The intervention group will receive Nut Fish based supplementation, multiple micro nutrients, and pregnancy class. The control group will receive government food supplementation, iron folic acid supplementation, and pregnancy class.
Objectives: To investigate whether a nut fish based food and dietary supplementation
delivered to pregnant mothers with health education would benefit maternal and birth outcomes
compared with the government standard of care.
Design. A randomized control trial will be implemented in rural community in Indonesia.
Intervention. The 2 trial arms will be control group (government standard of care) and
intervention group with nut fish based food and dietary supplementation and health education
series in the pregnancy class. A control group will receive government food supplementation
package, Iron Folic acid pills and pregnancy class. An intervention group will receive
NutFish based food supplementation, multiple micro nutrients, and pregnancy class. As a pilot
study, all the intervention packages will be delivered by research team members.
Subjects. A total 72 first trimester of pregnant mothers will be enrolled with 36 pregnant
mothers each group.
Outcome measures. Maternal outcome at 1 and 2 month after intervention namely weight
increment, energy and protein intake, mid upper arm circumference, and complications. Birth
outcomes include APGAR score, birth weight and length, preterm birth.
Analysis. Linear, logistic and multinomial logistic regression.
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