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

October 22, 2017 updated by: Kun Aristiati Susiloretni, Semarang Health Polytechnic
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Demak, Central Java, Indonesia, 50566
        • Demak District Health Office
    • Jawa Tengah
      • Demak, Jawa Tengah, Indonesia
        • Public Health Center of Karangawen 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semarang Health Polytechnic

Investigators

  • Principal Investigator: Kun A Susiloretni, Dr, Semarang Health Polytechnic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2016

Primary Completion (Anticipated)

October 30, 2017

Study Completion (Anticipated)

December 20, 2017

Study Registration Dates

First Submitted

August 27, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 22, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SemarangHP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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