NCT02959125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 12, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

August 27, 2016

Last Update Submit

October 22, 2017

Conditions

PregnancyProtein-Energy MalnutritionAnemia

Outcome Measures

Primary Outcomes (1)

  • Birth weight

    Infant weight (in grams) at birth

    at delivery

Secondary Outcomes (7)

  • APGAR score

    at delivery

  • Preterm birth

    at delivery

  • Birth length

    at delivery

  • Mid upper arm circumference

    baseline, 30 (+/- 3), and 60 (+/- 3) days

  • Gestational weight gain

    baseline, 30 (+/- 3), and 60 (+/- 3) days

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention * NutFish based supplementation for 60 days * Multiple micro nutrient for 60 days * Health education in pregnancy class

Other: NutFish Based Food SupplementationDietary Supplement: Multiple micronutrientsBehavioral: Health Education in Pregnancy Class

Control

ACTIVE COMPARATOR

Control * Government food supplementation for 60 days * Iron Folic acid for 60 days * Health education in pregnancy class

Behavioral: Health Education in Pregnancy ClassOther: Government Food SupplementationDietary Supplement: Fe Supplementation

Interventions

NutFish Based Food SupplementationOTHER

Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish

Intervention
Multiple micronutrientsDIETARY_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

Intervention
Health Education in Pregnancy ClassBEHAVIORAL

Health education on pregnancy, complication, and breastfeeding by research team members

Also known as: Intervention
ControlIntervention
Government Food SupplementationOTHER

Cookies contain 500 Calories and 5 gram protein make from flour and egg

Control
Fe SupplementationDIETARY_SUPPLEMENT

Ferrous Fumarate 60mg and folic acid 0.400 mg

Control

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe anemia \< 7.0g/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Demak District Health Office

Demak, Central Java, 50566, Indonesia

Location

Public Health Center of Karangawen 2

Demak, Central Java, Indonesia

Location

Related Publications (3)

  • 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.

    PMID: 26031211RESULT

  • 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.

    PMID: 22742610RESULT

  • 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.

    PMID: 26522344RESULT

MeSH Terms

Conditions

Protein-Energy MalnutritionAnemia

Interventions

Methods

Condition Hierarchy (Ancestors)

Protein DeficiencyDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Kun A Susiloretni, Dr

    Semarang Health Polytechnic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 27, 2016

First Posted

November 8, 2016

Study Start

December 12, 2016

Primary Completion

October 30, 2017

Study Completion

December 20, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Locations

ID(2)