An Investigation of the Effectiveness of the Mediterranean Diet in Pregnant Women at Risk of Developing Allergy in Their Infants: Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease.
研究概览
简要总结
There has been an increase in asthma and allergic disease prevalence, especially in children. Given the high prevalence, and the associated high disease burden and costs, there is an urgent need to identify effective strategies for the primary prevention of asthma and allergy. A systematic review of the literature has found strong supportive epidemiological evidence of a protective role for the Mediterranean Diet (MD).
The investigators aim is to undertake a pilot trial in a sample of pregnant women to establish recruitment, retention, a measurable change to a dietary intervention encouraging greater adherence to a MD during pregnancy, and acceptability of the dietary advice and diet modifications.
This pilot study will be a 2-arm randomised controlled trial (RCT) in a sample population of around 50 Scottish pregnant women.
This work ultimately aims to contribute to improving health outcomes through seeking to reduce the incidence of asthma and allergic problems. This pilot trial will prove invaluable in informing the subsequent planned definitive parallel group RCT.
详细描述
Aims
The primary aims of this pilot trial are to investigate rates of maternal recruitment and retention, and adherence with a MD during the latter two trimesters of pregnancy (i.e. weeks 12 to 36). The secondary aims are to determine whether there is any subsequent measurable change in the Mediterranean Diet score and whether the dietary advice and diet modifications are acceptable.
Research questions
- What are the recruitment and retention rates of pregnant mothers whose infants are at high risk of atopic disease?
- Is the advice and dietary modification acceptable to participants?
- To what extent are mothers able to adhere to a MD?
- Can a MD score be increased in pregnancy?
- Can a measurable change in a biomarker of oxidative stress be detected as a result of adherence to a MD?
- Can any increases in MD be sustained during pregnancy?
Design
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
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant in first trimester
- •Age 16 years and above
- •One or more first degree blood relatives of the baby with atopic dermatitis(eczema), food allergy, allergic rhinitis (persistent or intermittent) or asthma
- •Willing to give informed consent
排除标准
- •Age <16 years
- •No first degree blood relatives of the baby with atopic dermatitis (eczema), food allergy, allergic rhinitis (persistent or intermittent) or asthma
- •Recent (within the last 3 months) or current involvement in a dietary or supplementation trial
- •Unable to give informed consent
研究组 & 干预措施
Dietary support
Face to face intervention plus subsequent telephone support
干预措施: Dietary support (Behavioral)
No dietary support
No face to face intervention plus subsequent telephone support
干预措施: No dietary support (Behavioral)
结局指标
主要结局
Recruitment rate of pregnant mothers whose infants are at high risk of atopic disease.
时间窗: 4 months
次要结局
- Mediterranean Diet score in pregnancy(12 and 24 weeks post-intervention)
研究者
Dean A. Sewell
Senior Lecturer in Human Physiology and Metabolism
Heriot-Watt University