Nutrition and Food Choices in Early Pregnancy - a Nutrition Education Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- proportion of women not meeting the recommended intake for iodine
研究概览
简要总结
PICk study is a mHealth intervention in women trying to conceive and women up to 14 weeks pregnant, aiming to guide food choices, to achieve the recommended iodine intake through diet.
详细描述
Iodine is important for the synthesis of thyroid hormones, which are driving normal brain development in fetal and postnatal life.
The required level of iodine intake is 140μg/day and there is not proposed increment for pregnant women from the United Kingdom (UK) Department of Health, in contrast to the World Health Organisation (WHO), EFSA, US Institute of Medicine (IoM) and SANZ, that propose an intake in pregnancy which varies from 200 to 150μg/day. In the UK, based on our previous findings, 60% of women in pregnancy do not meet the 250μg/day WHO recommendation of intake.
Over half mothers and practitioners in the UK were found to be unable to identify correct sources of iodine. However, most women have reported willingness to modify dietary behaviour if they received information related to the importance of iodine in pregnancy.
This intervention focuses on providing information about iodine and its importance in pregnancy that would potentially help women improve their iodine status. The intervention was designed with participants involvement and their views on best way of getting information, informed by in-depth qualitative work.
The hypothesis is that increasing knowledge and awareness about the importance, sources and requirements of iodine during pregnancy will lead to change in practice and increased iodine intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Both groups (control and intervention) will be informed that the main aim of the study is to assess the impact of food guidance on the micronutrient intake in pregnant women. The intervention group will receive texts with detailed information focusing on nutrition and iodine rich foods specifically. The information sheet will have information on all the study procedures but the focus on iodine will remain discreet, to avoid unintended bias in response from participants. At the end of the study, participants will be debriefed on the deception.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Trying to conceive or first trimester pregnant women
- •English speaking
排除标准
- •Abnormal pregnancies
- •Known thyroid disorders, renal disease, multiple pregnancies, development of gestational diabetes
- •Participation in another trial
- •Not owning a mobile phone
- •Followed by a dietitian at the time of the trial
- •Existing or past eating disorders
研究组 & 干预措施
Control group
The control group will receive no intervention, and will be receiving only text reminders regarding the study, the following visits and study logistics in order to limit dropout rate.
Intervention group
Intervention will happen with weekly text messages during the study period, focusing on pregnancy nutrition and iodine rich foods. The texts will be based on the taxonomy of behavior change techniques used in interventions, the nudge theory and will be covering themes identified on our previous research.
干预措施: Text messages (Behavioral)
结局指标
主要结局
proportion of women not meeting the recommended intake for iodine
时间窗: 12 weeks
measured by validated food frequency questionnaire
proportion of women not meeting the recommended intake for iodine
时间窗: 6 weeks
measured by validated food frequency questionnaire
次要结局
- iodine awareness(12 weeks)
- Iodine knowledge(12 weeks)
- Thyroglobulin concentration(12 weeks)
- Change in urinary iodine concentration (from baseline)(12 weeks)
- Change in urinary iodine concentration (from baseline)(6 weeks)
- iodine awareness(6 weeks)
- Iodine knowledge(6 weeks)
- Thyroglobulin concentration(6 weeks)
研究者
Emilie Combet
Principal Investigator
University of Glasgow