NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes

Phase

N/A

Condition

Pregnancy

Diet And Nutrition

Weight Loss

Treatment

N/A

Clinical Study ID

NCT02959125

SemarangHP

Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

First trimester of pregnancy
Anemic or Mid Upper Arm Circumference < 23.5cm or no weight gain
Plan to deliver at village midwives
residence in the study area

Exclusion

Exclusion Criteria:

severe anemia < 7.0g/dl

Study Design

December 12, 2016

December 20, 2017

Study Description

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.

Connect with a study center

Demak District Health Office
Demak, Central Java 50566
Indonesia
Site Not Available
Public Health Center of Karangawen 2
Demak, Jawa Tengah
Indonesia
Site Not Available

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