Designing and implementing a maternal iron deficiency and anaemia control strategy in India using a social norms approach and a Self Help Group (SHGs) platform.
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 4,110
- 试验地点
- 1
- 主要终点
- Aneamia status through hemoglobin tests and IFA utilization (purchase and consumption)
研究概览
简要总结
Anemia is a major health concern in Odisha, India where approximately half of women of reproductive age (WRA) are anemic. One of the primary recommendations made by the World Health Organization (WHO) for WRA in India is daily oral iron and folic acid (IFA) supplementation during pregnancy and postpartum period together with uptake of deworming medicines and anti-malarial medicines where appropriate. However, both initial supplement intake and compliance remain inadequate. Some of the primary barriers include: lack of knowledge about the cause of anemia and its health consequences, lack of information from health care providers around the connection between IFA tablets and reduction in anemia, forgetfulness, myths and misperceptions around the effects of IFA tablets on a woman’s body or her fetus, and both perceived as well as experienced side effects of IFA.
We seek to promote changes in social norms, knowledge, attitudes, and behaviors of WRA and pregnant women in Odisha through a communication-based behavioral intervention that will operate in existing Self Help Groups. This is not an efficacy trial. We seek to only increase demand for IFA tablets among WRA, as per the recommendations set forth by the Government of Odisha; 239 randomly selected villages were randomized into treatment and control arms so that there are 130 villages villages exposed to the behavioral intervention and 109 that are not.
We hypothesize that exposure to the behavioral intervention will result in increases in IFA demand and utilization, and subsequently reductions in anemia. We will test this hypothesis through measuring change in hemoglobin level, IFA use, knowledge, attitudes, beliefs, and perceptions in approximately 2,061 randomly selected pregnant and non-pregnant WRA that reside in the intervention arm and 2,049 randomly selected WRA that reside in the control arm. A small sub-cohort of non-pregnant women will be randomly selected from this group for further measurements of change in physical activity and cognitive functioning. Women in the treatment group who own a phone will also be randomized into a sub-study delivered through a mobile health platform. These women will either be randomized into an arm where they will receive norms-based anemia messages, violence against women bystander messages (positive control), or nothing at all (negative control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)(—)
- 性别
- Female
入选标准
- •Outcomes will be measured in pregnant and non-pregnant women of reproductive age.
排除标准
- •Participants must live in the selected villages.
- •Pregnant women will be excluded from the physical activity tests or cognitive functioning tests.
结局指标
主要结局
Aneamia status through hemoglobin tests and IFA utilization (purchase and consumption)
时间窗: Aug-Sept 2019; Feb-March 2020; September-October 2020
次要结局
- work capacity (modified Queens College Step test)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- IFA supplement purchase and procurement(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- social norms, gender norms knowledge, self-efficacy, mental health, attitudes, nutrition, WASH, and de-worming (from questionnaires)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- socio-cognitive functioning (through Simple Reaction Time task, Corsi Block Test, Simon Test, and word span assessments)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- Anemia testing (self-report)(Feb-March 2020; September-October 2020)
- Exposure to intervention(Feb-March 2020; September-October 2020)
- BMI (weight and height measurements)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- self efficacy to intervene on violence against women (for the control arm of mHealth component)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
- Psychical Activity (through ActivePal)(Aug-Sept 2019; Feb-March 2020; September-October 2020)
