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

Semarang Health Polytechnic

Status: Unknown

Conditions: Anemia; Protein-Energy Malnutrition; Pregnancy

Treatments: Other: NutFish Based Food Supplementation; Dietary Supplement: Multiple micronutrients; Dietary Supplement: Fe Supplementation; Behavioral: Health Education in Pregnancy Class; Other: Government Food Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02959125

SemarangHP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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 criteria

• severe anemia < 7.0g/dl

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Intervention

Experimental group

Description:

Intervention * NutFish based supplementation for 60 days * Multiple micro nutrient for 60 days * Health education in pregnancy class

Treatment:

Behavioral: Health Education in Pregnancy Class

Other: NutFish Based Food Supplementation

Dietary Supplement: Multiple micronutrients

Control

Active Comparator group

Description:

Control * Government food supplementation for 60 days * Iron Folic acid for 60 days * Health education in pregnancy class

Treatment:

Dietary Supplement: Fe Supplementation

Behavioral: Health Education in Pregnancy Class

Other: Government Food Supplementation