Clinical trial NCT02959125: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Protein-Energy Malnutrition
Anemia
Lead sponsor: Semarang Health Polytechnic
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 72
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Birth weight
timeFrame: at delivery
Secondary outcomes:
measure: APGAR score
timeFrame: at delivery
measure: Preterm birth
timeFrame: at delivery
measure: Birth length
timeFrame: at delivery
measure: Mid upper arm circumference
timeFrame: baseline, 30 (+/- 3), and 60 (+/- 3) days
measure: Gestational weight gain
timeFrame: baseline, 30 (+/- 3), and 60 (+/- 3) days
measure: Dietary intake
timeFrame: baseline, 30 (+/- 3), and 60 (+/- 3) days
measure: Problems experience
timeFrame: baseline, 30 (+/- 3), and 60 (+/- 3) days
Other outcomes:
Locations:
city: Demak
country: Indonesia
facility: Demak District Health Office
state: Central Java
city: Demak
country: Indonesia
facility: Public Health Center of Karangawen 2
state: Jawa Tengah
Study officials:
affiliation: Semarang Health Polytechnic
name: Kun A Susiloretni, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.