NutFish and Nutrient Supplementation in Pregnancy Class to Improve Maternal and Birth Outcomes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Birth weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •severe anemia < 7.0g/dl
研究组 & 干预措施
Intervention
Intervention
- NutFish based supplementation for 60 days
- Multiple micro nutrient for 60 days
- Health education in pregnancy class
干预措施: Health Education in Pregnancy Class (Behavioral)
Intervention
Intervention
- NutFish based supplementation for 60 days
- Multiple micro nutrient for 60 days
- Health education in pregnancy class
干预措施: NutFish Based Food Supplementation (Other)
Intervention
Intervention
- NutFish based supplementation for 60 days
- Multiple micro nutrient for 60 days
- Health education in pregnancy class
干预措施: Multiple micronutrients (Dietary Supplement)
Control
Control
- Government food supplementation for 60 days
- Iron Folic acid for 60 days
- Health education in pregnancy class
干预措施: Health Education in Pregnancy Class (Behavioral)
Control
Control
- Government food supplementation for 60 days
- Iron Folic acid for 60 days
- Health education in pregnancy class
干预措施: Government Food Supplementation (Other)
Control
Control
- Government food supplementation for 60 days
- Iron Folic acid for 60 days
- Health education in pregnancy class
干预措施: Fe Supplementation (Dietary Supplement)
结局指标
主要结局
Birth weight
时间窗: at delivery
Infant weight (in grams) at birth
次要结局
- 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)
- Dietary intake(baseline, 30 (+/- 3), and 60 (+/- 3) days)
- Problems experience(baseline, 30 (+/- 3), and 60 (+/- 3) days)
研究者
Kun Aristiati Susiloretni
Dr
Semarang Health Polytechnic