Trial | NCT02959125  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    iron ...

  • Study Participants

    72
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.
Study Started
Dec 12
2016
Primary Completion
Oct 30
2017
Anticipated
Study Completion
Dec 20
2017
Anticipated
Last Update
Oct 24
2017

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 names: Intervention

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

Intervention Experimental

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

Control Active Comparator

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

Criteria 

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
No Results Posted