NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
Primary Purpose
Pregnancy, Protein-Energy Malnutrition, Anemia
Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
NutFish Based Food Supplementation
Multiple micronutrients
Health Education in Pregnancy Class
Government Food Supplementation
Fe Supplementation
Sponsored by
About this trial
This is an interventional health services research trial for Pregnancy
Eligibility Criteria
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
Sites / Locations
- Demak District Health Office
- Public Health Center of Karangawen 2
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
Intervention NutFish based supplementation for 60 days Multiple micro nutrient for 60 days Health education in pregnancy class
Control Government food supplementation for 60 days Iron Folic acid for 60 days Health education in pregnancy class
Outcomes
Primary Outcome Measures
Birth weight
Infant weight (in grams) at birth
Secondary Outcome Measures
APGAR score
Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
Preterm birth
Delivery before 37 weeks gestation
Birth length
Infant length (in centimeters) at birth
Mid upper arm circumference
measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow
Gestational weight gain
Weight gained during pregnancy as compared to medical recommendation
Dietary intake
% nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
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
Full Information
NCT ID
NCT02959125
First Posted
August 27, 2016
Last Updated
October 22, 2017
Sponsor
Semarang Health Polytechnic
1. Study Identification
Unique Protocol Identification Number
NCT02959125
Brief Title
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
Official Title
NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
October 30, 2017 (Anticipated)
Study Completion Date
December 20, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semarang Health Polytechnic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Protein-Energy Malnutrition, Anemia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention
NutFish based supplementation for 60 days
Multiple micro nutrient for 60 days
Health education in pregnancy class
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control
Government food supplementation for 60 days
Iron Folic acid for 60 days
Health education in pregnancy class
Intervention Type
Other
Intervention Name(s)
NutFish Based Food Supplementation
Intervention Description
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple micronutrients
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health Education in Pregnancy Class
Other Intervention Name(s)
Intervention
Intervention Description
Health education on pregnancy, complication, and breastfeeding by research team members
Intervention Type
Other
Intervention Name(s)
Government Food Supplementation
Intervention Description
Cookies contain 500 Calories and 5 gram protein make from flour and egg
Intervention Type
Dietary Supplement
Intervention Name(s)
Fe Supplementation
Intervention Description
Ferrous Fumarate 60mg and folic acid 0.400 mg
Primary Outcome Measure Information:
Title
Birth weight
Description
Infant weight (in grams) at birth
Time Frame
at delivery
Secondary Outcome Measure Information:
Title
APGAR score
Description
Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration
Time Frame
at delivery
Title
Preterm birth
Description
Delivery before 37 weeks gestation
Time Frame
at delivery
Title
Birth length
Description
Infant length (in centimeters) at birth
Time Frame
at delivery
Title
Mid upper arm circumference
Description
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
Title
Gestational weight gain
Description
Weight gained during pregnancy as compared to medical recommendation
Time Frame
baseline, 30 (+/- 3), and 60 (+/- 3) days
Title
Dietary intake
Description
% nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe
Time Frame
baseline, 30 (+/- 3), and 60 (+/- 3) days
Title
Problems experience
Description
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
Time Frame
baseline, 30 (+/- 3), and 60 (+/- 3) days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun A Susiloretni, Dr
Organizational Affiliation
Semarang Health Polytechnic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Demak District Health Office
City
Demak
State/Province
Central Java
ZIP/Postal Code
50566
Country
Indonesia
Facility Name
Public Health Center of Karangawen 2
City
Demak
State/Province
Jawa Tengah
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26031211
Citation
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.
Results Reference
result
PubMed Identifier
22742610
Citation
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.
Results Reference
result
PubMed Identifier
26522344
Citation
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.
Results Reference
result
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NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
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