NCT05685056

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

2.2 years

First QC Date

October 30, 2017

Last Update Submit

January 6, 2023

Conditions

Iodine Deficiency

Keywords

IodinePregnancyFood choicesFishDairy

Outcome Measures

Primary Outcomes (2)

  • proportion of women not meeting the recommended intake for iodine

    measured by validated food frequency questionnaire

    6 weeks

  • proportion of women not meeting the recommended intake for iodine

    measured by validated food frequency questionnaire

    12 weeks

Secondary Outcomes (8)

  • iodine awareness

    6 weeks

  • iodine awareness

    12 weeks

  • Iodine knowledge

    6 weeks

  • Iodine knowledge

    12 weeks

  • Thyroglobulin concentration

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Text messages

Interventions

Text messagesBEHAVIORAL

Texts with detailed information focusing on nutrition and iodine rich foods specifically, every 3-5 days.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale because pregnancy focus
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Trying to conceive or first trimester pregnant women
  • English speaking
  • Healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community

Glasgow, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 30, 2017

First Posted

January 13, 2023

Study Start

March 25, 2017

Primary Completion

June 17, 2019

Study Completion

October 30, 2019

Last Updated

January 13, 2023

Record last verified: 2023-01

Locations

GB(1)