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PregnancyNCT02959125

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

A study testing NutFish Based Food Supplementation, Multiple micronutrients and Health Education in Pregnancy Class in people with Pregnancy and Protein-Energy Malnutrition, run by Semarang Health Polytechnic at 2 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Pregnancy, Protein-Energy Malnutrition, Anemia
What is being tested?
NutFish Based Food Supplementation, Multiple micronutrients and Health Education in Pregnancy Class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesIndonesia
Study dates
12 Dec 2016to 20 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • severe anemia < 7.0g/dl

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Demak District Health Office

    Demak, Central Java, 50566

  • Public Health Center of Karangawen 2

    Demak, Central Java

Other trials in Indonesia

About this study

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.

Read the 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.

Being tested
NutFish Based Food Supplementation, Multiple micronutrients, Health Education in Pregnancy Class, Government Food Supplementation, Fe Supplementation
Medical subject headings
Protein-Energy Malnutrition, Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NutFish Based Food SupplementationOther

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

  • 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

  • Health Education in Pregnancy ClassBehavioural

    Also called Intervention

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

  • Government Food SupplementationOther

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

  • Fe SupplementationDietary supplement

    Ferrous Fumarate 60mg and folic acid 0.400 mg

Study groups in NCT02959125
Study groupRoleWhat they receive
InterventionExperimentalIntervention * NutFish based supplementation for 60 days * Multiple micro nutrient for 60 days * Health education in pregnancy class
Receives: Other: NutFish Based Food Supplementation; Dietary Supplement: Multiple micronutrients; Behavioral: Health Education in Pregnancy Class
ControlActive comparatorControl * Government food supplementation for 60 days * Iron Folic acid for 60 days * Health education in pregnancy class
Receives: Behavioral: Health Education in Pregnancy Class; Other: Government Food Supplementation; Dietary Supplement: Fe Supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Birth weight

    Infant weight (in grams) at birth

    Measured: at delivery

Secondary outcomes (7)

  1. APGAR score

    Five criteria used as an index of health in the immediate neonatal period : Appearance, Pulse, Grimace, Activity, Respiration

    Measured: at delivery

  2. Preterm birth

    Delivery before 37 weeks gestation

    Measured: at delivery

  3. Birth length

    Infant length (in centimeters) at birth

    Measured: at delivery

  4. Mid upper arm circumference

    measured in centimeters, at the mid-point between the tip of the shoulder and the tip of the elbow

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

  5. Gestational weight gain

    Weight gained during pregnancy as compared to medical recommendation

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

  6. Dietary intake

    % nutrient intake compare to estimated average requirements (EAR). Dietary intake: energy, protein, zinc, Fe

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

  7. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2016 (estimated)
  2. Study start12 Dec 2016
  3. Primary completion30 Oct 2017 (estimated)
  4. Study completion20 Dec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02959125
Sponsor's protocol ID
SemarangHP
Status last verified
Oct 2017
First submitted
27 Aug 2016
Last updated
24 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26031211

  • 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.

    PubMed 22742610

  • 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.

    PubMed 26522344

Questions about this trial

What is this clinical trial studying?

A study testing NutFish Based Food Supplementation, Multiple micronutrients and Health Education in Pregnancy Class in people with Pregnancy and Protein-Energy Malnutrition, run by Semarang Health Polytechnic at 2 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Birth weight (time frame: at delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02959125, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.

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