Anemia, Pregnancy, Protein-Energy Malnutrition
Conditions
Brief 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.
Interventions
OTHERNutFish Based Food Supplementation
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
DIETARY_SUPPLEMENTMultiple 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
BEHAVIORALHealth Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
OTHERGovernment Food Supplementation
Cookies contain 500 Calories and 5 gram protein make from flour and egg
DIETARY_SUPPLEMENTFe Supplementation
Ferrous Fumarate 60mg and folic acid 0.400 mg
Sponsors
Semarang Health Polytechnic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight | at delivery | Infant weight (in grams) at birth |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preterm birth | at delivery | Delivery before 37 weeks gestation |
| Birth length | at delivery | Infant length (in centimeters) at birth |
| Mid upper arm circumference | baseline, 30 (+/- 3), and 60 (+/- 3) days | measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow |
| APGAR score | at delivery | Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration |
| Dietary intake | baseline, 30 (+/- 3), and 60 (+/- 3) days | % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe |
| Problems experience | baseline, 30 (+/- 3), and 60 (+/- 3) days | 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 |
| Gestational weight gain | baseline, 30 (+/- 3), and 60 (+/- 3) days | Weight gained during pregnancy as compared to medical recommendation |
Countries
Indonesia
Outcome results
None listed