Nutrition & Food Choices in Early Pregnancy
Condition: Iodine Deficiency
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Methods:

      The study is a randomised controlled trial that lasts for 12 weeks. Women in preconception
      and in the 1st pregnancy trimester will be recruited and will be randomised either to the
      control or to the intervention group.

      The study involves 3 meeting with the participants, at baseline and after 6 and 12 weeks. For
      women who try to conceive, if conception occurs within the study period, there is a fourth
      (optional) meeting in the 12th week of pregnancy.

      Participants are informed about the study without getting details of the aim (to increase the
      iodine status of those in the treatment group). This is in order to decrease any bias and
      avoid leading participants to self-research the topic of iodine nutrition. Women of both
      study arms receive standard care and the study will not aim to change this. The treatment
      group is to receive 1-2 weekly text messages focusing on iodine-rich foods importance,
      barriers identification and tips with ways to include them in the diet.

      Samples collection and analysis:

        -  Questionnaires (demographic, dietary, knowledge, awareness and intervention assessment
           questionnaires) will be completed by the participants at the place of recruitment /
           meeting with the researcher after full instructions by the researcher in visits 1, 2 and
           3 (and optional visit 4).

        -  Participants will be given 12 pots for spot urine samples collection in each visit. They
           will be asked to collect 10 urine samples over 3-4 days. Urinary iodine and creatinine
           concentrations will be measured.

        -  A finger prick dried blood spot sample will be taken from each participant in each visit
           by the researcher. Thyroglobulin will be measured.

      Power calculation:

      The primary aim of the study is to decrease the proportion of women not meeting the
      recommended intake for iodine.

      Based on a proportion of 60% of women currently not meeting the 250 μg/day recommended intake
      5, a sample size of N=84 in total (42 per group) would allow to detect a decrease in
      proportion down to 30%. This is achievable based on the % of women with an intake of 150-249
      μg/day, who could increase consumption by 100 μg/day (equivalent to a 200ml portion of milk
      and a 125g portion of yoghurt per day) and therefore meet the threshold. Adjusting for 15%
      dropout, a sample of 50 per group would be sufficient.
    

Intervention name(s): Text messages
Intervention type(s): Behavioral
Intervention description(s): Texts with detailed information focusing on nutrition and iodine rich foods specifically, every 3-5 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Iodine; Pregnancy; Food choices; Fish; Dairy