NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
NCT ID: NCT02959125
Last Updated: 2017-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2016-12-12
2017-12-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention
Intervention
* NutFish based supplementation for 60 days
* Multiple micro nutrient for 60 days
* Health education in pregnancy class
NutFish Based Food Supplementation
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
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
Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
Control
Control
* Government food supplementation for 60 days
* Iron Folic acid for 60 days
* Health education in pregnancy class
Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
Government Food Supplementation
Cookies contain 500 Calories and 5 gram protein make from flour and egg
Fe Supplementation
Ferrous Fumarate 60mg and folic acid 0.400 mg
Interventions
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NutFish Based Food Supplementation
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
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
Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
Government Food Supplementation
Cookies contain 500 Calories and 5 gram protein make from flour and egg
Fe Supplementation
Ferrous Fumarate 60mg and folic acid 0.400 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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Semarang Health Polytechnic
OTHER
Responsible Party
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Kun Aristiati Susiloretni
Dr
Principal Investigators
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Kun A Susiloretni, Dr
Role: PRINCIPAL_INVESTIGATOR
Semarang Health Polytechnic
Locations
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Demak District Health Office
Demak, Central Java, Indonesia
Public Health Center of Karangawen 2
Demak, Central Java, Indonesia
Countries
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References
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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;(6):CD000032. doi: 10.1002/14651858.CD000032.pub3.
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.
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.
Other Identifiers
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SemarangHP
Identifier Type: -
Identifier Source: org_study_id