Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)
试验速览
- 阶段
- 3 期
- 入组人数
- 25,447
- 试验地点
- 1
- 主要终点
- Low birth weight
研究概览
简要总结
The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Minimum age at enrolment: 15 years
- •Maximum age at enrolment: 23 years
- •Any marital status
- •Intend to comply with study intervention and follow up
排除标准
- •Women participating in other nutrition trials
- •Women who intend to leave the study area
- •Women who are already pregnant
研究组 & 干预措施
Standard of care
- Preconception period: none
- Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
- Postpartum period: daily iron and folic acid supplementation to 6 months postpartum
MMN supplementation and life skills education
- Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials
- Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
- Postpartum period: daily MMN supplementation to 6 months postpartum
干预措施: Multiple micronutrients (UNIMMAP composition) (Dietary Supplement)
MMN supplementation and life skills education
- Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials
- Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
- Postpartum period: daily MMN supplementation to 6 months postpartum
干预措施: Life skills based education (Behavioral)
结局指标
主要结局
Low birth weight
时间窗: At birth
Birth weight \<2500 g
Anemia status
时间窗: 0, 12*, 24 months (*in subgroup only)
Hemoglobin concentration \<12 g/dL
次要结局
- Anthropometrics: height (women)(Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months)
- Anthropometrics: middle upper arm circumference (women)(Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months)
- Gestational age(At birth)
- Birth size: weight(Within 24 hours of birth)
- Age at marriage(Enrolment, 1 year, 2 years)
- Dietary intake: 24-hour recall (subgroup of women)(Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks)
- Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)(Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week)
- Stillbirth(At birth)
- Birth size: length(Within 24 hours of birth)
- Anthropometrics: weight (women)(Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months)
- Small for gestational age(At birth)
- Birth size: head circumference(Within 24 hours of birth)
- Infant growth: length(1, 3, 6, 9, 12 months)
- Preterm birth(At birth)
- Birth size: middle upper arm circumference(Within 24 hours of birth)
- Birth defects(At birth)
- Infant growth: middle upper arm circumference(1, 3, 6, 9, 12 months)
- Infant growth: weight(1, 3, 6, 9, 12 months)
- Infant growth: head circumference(1, 3, 6, 9, 12 months)
- Completion of 10th grade education(Enrolment, 1 year, 2 years)
- Use of sanitary pad during last menstrual period(Enrolment, 1 year, 2 years)
研究者
Dr Zulfiqar Ahmed Bhutta
Director, Centre of Excellence in Women and Child Health
Aga Khan University