NCT02959125

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Semarang Health Polytechnic · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pregnancy
• Protein-Energy Malnutrition
• Anemia

Interventions

Type	Name	Description
OTHER	NutFish Based Food Supplementation	Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
DIETARY_SUPPLEMENT	Multiple micronutrients	Vitamin A 5000 iu, vitamin D 400 iu, vitamin C 100 mg, vitamin B1 7.5 mg, vitamin B2 3 mg, vitamin B6 10 mg, vitamin B12 10 mcg, fluoride 1 mg, Fe fumarate 91 mg, niacinamide 20 mg, Ca pantothenate 7.5 mg, folic acid 400 mcg, Zn 5 mg, Ca lactate 250 mg, copper 0.1 mg, iodine 0.1 mg
BEHAVIORAL	Health Education in Pregnancy Class	Health education on pregnancy, complication, and breastfeeding by research team members
OTHER	Government Food Supplementation	Cookies contain 500 Calories and 5 gram protein make from flour and egg
DIETARY_SUPPLEMENT	Fe Supplementation	Ferrous Fumarate 60mg and folic acid 0.400 mg

Timeline

• Start date: 2016-12-12
• Primary completion: 2017-10-30
• Completion: 2017-12-20
• First posted: 2016-11-08
• Last updated: 2017-10-24

Locations

2 sites across 1 country: Indonesia