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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Protein-Energy Malnutrition, Anemia

Intervention / Treatment
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* Other: NutFish Based Food Supplementation
* Dietary Supplement: Multiple micronutrients
* Behavioral: Health Education in Pregnancy Class
* Other: Government Food Supplementation
* Dietary Supplement: Fe Supplementation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention NutFish based supplementation for 60 days Multiple micro nutrient for 60 days Health education in pregnancy class | Other: NutFish Based Food Supplementation<br>* Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish<br>Dietary Supplement: Multiple micronutrients<br>* 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<br>Behavioral: Health Education in Pregnancy Class<br>* Health education on pregnancy, complication, and breastfeeding by research team members<br>* Other names: Intervention;|
| Active Comparator: Control<br>Control Government food supplementation for 60 days Iron Folic acid for 60 days Health education in pregnancy class | Behavioral: Health Education in Pregnancy Class<br>* Health education on pregnancy, complication, and breastfeeding by research team members<br>* Other names: Intervention;Other: Government Food Supplementation<br>* Cookies contain 500 Calories and 5 gram protein make from flour and egg<br>Dietary Supplement: Fe Supplementation<br>* Ferrous Fumarate 60mg and folic acid 0.400 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight | Infant weight (in grams) at birth | at delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score | Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration | at delivery | 
| Preterm birth | Delivery before 37 weeks gestation | at delivery | 
| Birth length | Infant length (in centimeters) at birth | 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 | baseline, 30 (+/- 3), and 60 (+/- 3) days | 
| Gestational weight gain | Weight gained during pregnancy as compared to medical recommendation | baseline, 30 (+/- 3), and 60 (+/- 3) days | 
| Dietary intake | % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe | 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 | baseline, 30 (+/- 3), and 60 (+/- 3) days |