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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
72
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
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
Health education on pregnancy, complication, and breastfeeding by research team members
Demak District Health Office
Demak, Central Java, Indonesia
Public Health Center of Karangawen 2
Demak, Central Java, Indonesia
Birth weight
Infant weight (in grams) at birth
Time frame: at delivery
APGAR score
Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
Time frame: at delivery
Preterm birth
Delivery before 37 weeks gestation
Time frame: at delivery
Birth length
Infant length (in centimeters) at birth
Time frame: at delivery
Mid upper arm circumference
measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow
Time frame: baseline, 30 (+/- 3), and 60 (+/- 3) days
Gestational weight gain
Weight gained during pregnancy as compared to medical recommendation
Time frame: baseline, 30 (+/- 3), and 60 (+/- 3) days
Dietary intake
% nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
Time frame: baseline, 30 (+/- 3), and 60 (+/- 3) days
Problems experience
Number of problems(minor and serious) experience by the mother during pregnancy. Minor problems include: backache, constipation, cramp, feeling faint, hot, headache, etc. Serious problem: Slow-growing babies, Vaginal bleeding, Deep vein thrombosis, High blood pressure, pre-eclampsia, etc We will aggregate in minor and serious problems
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cookies contain 500 Calories and 5 gram protein make from flour and egg
Ferrous Fumarate 60mg and folic acid 0.400 mg
Time frame: baseline, 30 (+/- 3), and 60 (+/- 3) days