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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention
|
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| Control | Active Comparator | Control
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NutFish Based Food Supplementation | Other | Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | Infant weight (in grams) at birth | at delivery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun A Susiloretni, Dr | Semarang Health Polytechnic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demak District Health Office | Demak | Central Java | 50566 | Indonesia | ||
| Public Health Center of Karangawen 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26031211 | Result | Ota E, Hori H, Mori R, Tobe-Gai R, Farrar D. Antenatal dietary education and supplementation to increase energy and protein intake. Cochrane Database Syst Rev. 2015 Jun 2;2015(6):CD000032. doi: 10.1002/14651858.CD000032.pub3. | |
| 22742610 | Result | Imdad A, Bhutta ZA. Maternal nutrition and birth outcomes: effect of balanced protein-energy supplementation. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:178-90. doi: 10.1111/j.1365-3016.2012.01308.x. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 17, 2019 | |
| Reset | Oct 10, 2019 | |
| Release | Sep 21, 2021 |
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| Multiple micronutrients | Dietary Supplement | 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 in Pregnancy Class | Behavioral | Health education on pregnancy, complication, and breastfeeding by research team members |
|
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| Government Food Supplementation | Other | Cookies contain 500 Calories and 5 gram protein make from flour and egg |
|
| Fe Supplementation | Dietary Supplement | Ferrous Fumarate 60mg and folic acid 0.400 mg |
|
| 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 |
| Demak |
| Central Java |
| Indonesia |
| 26522344 | Result | Haider BA, Bhutta ZA. Multiple-micronutrient supplementation for women during pregnancy. Cochrane Database Syst Rev. 2015 Nov 1;2015(11):CD004905. doi: 10.1002/14651858.CD004905.pub4. |
| Reset | Oct 19, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 17, 2019 | Oct 10, 2019 | |||
| Sep 21, 2021 | Oct 19, 2021 |
| ID | Term |
|---|---|
| D011502 | Protein-Energy Malnutrition |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D011488 | Protein Deficiency |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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