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

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ClinicalTrials.gov Identifier: NCT02959125
Recruitment Status : Unknown
Verified October 2017 by Kun Aristiati Susiloretni, Semarang Health Polytechnic.
Recruitment status was:  Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):
Kun Aristiati Susiloretni, Semarang Health Polytechnic

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.

Condition or disease Intervention/treatment Phase
Pregnancy Protein-Energy Malnutrition Anemia Other: NutFish Based Food Supplementation Dietary Supplement: Multiple micronutrients Behavioral: Health Education in Pregnancy Class Other: Government Food Supplementation Dietary Supplement: Fe Supplementation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : October 30, 2017
Estimated Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention

Intervention

  • NutFish based supplementation for 60 days
  • Multiple micro nutrient for 60 days
  • Health education in pregnancy class
Other: NutFish Based Food Supplementation
Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish

Dietary Supplement: 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

Behavioral: Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
Other Name: Intervention

Active Comparator: Control

Control

  • Government food supplementation for 60 days
  • Iron Folic acid for 60 days
  • Health education in pregnancy class
Behavioral: Health Education in Pregnancy Class
Health education on pregnancy, complication, and breastfeeding by research team members
Other Name: Intervention

Other: Government Food Supplementation
Cookies contain 500 Calories and 5 gram protein make from flour and egg

Dietary Supplement: Fe Supplementation
Ferrous Fumarate 60mg and folic acid 0.400 mg




Primary Outcome Measures :
  1. Birth weight [ Time Frame: at delivery ]
    Infant weight (in grams) at birth


Secondary Outcome Measures :
  1. APGAR score [ Time Frame: at delivery ]
    Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration

  2. Preterm birth [ Time Frame: at delivery ]
    Delivery before 37 weeks gestation

  3. Birth length [ Time Frame: at delivery ]
    Infant length (in centimeters) at birth

  4. Mid upper arm circumference [ Time Frame: 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

  5. Gestational weight gain [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    Weight gained during pregnancy as compared to medical recommendation

  6. Dietary intake [ Time Frame: baseline, 30 (+/- 3), and 60 (+/- 3) days ]
    % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe

  7. Problems experience [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959125


Locations
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Indonesia
Demak District Health Office
Demak, Central Java, Indonesia, 50566
Public Health Center of Karangawen 2
Demak, Jawa Tengah, Indonesia
Sponsors and Collaborators
Semarang Health Polytechnic
Investigators
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Principal Investigator: Kun A Susiloretni, Dr Semarang Health Polytechnic
Publications of Results:
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Responsible Party: Kun Aristiati Susiloretni, Dr, Semarang Health Polytechnic
ClinicalTrials.gov Identifier: NCT02959125    
Other Study ID Numbers: SemarangHP
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs