Identifying the Best Tools for Recording Diet in Free-living UK Adults (SODIAT-2 Study)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Reading
About this trial
The aim of the SODIAT-2 study is to evaluate the effectiveness of dietary intake assessment tools in a real-world setting. These tools include wearable cameras, spot urine samples, capillary blood samples, and a web-based food frequency questionnaire (FFQ). The main questions it aims to answer are:
Is the accuracy of dietary assessment improved in free-living environments when a combination of subjective and objective assessments tools are used?
Secondary research questions are:
Can wearable cameras accurately monitor the daily dietary intake of free-living individuals? Does a combination of capillary blood samples and spot urine samples provide a robust assessment of the nutrient status and habitual dietary exposure in a free-living setting? Can data-driven integration of multiple emerging technologies create a dietary assessment tool that is low burden, accurate and scalable in free-living populations? Can a condensed FFQ estimate diet quality as effectively as a detailed FFQ?
Participants will:
Use the dietary assessment tools (wearable camera, spot urine, capillary blood, and eNutri FFQ web-app) as instructed over a 5-week period from their home and/or working space.
Take part in two monitoring weeks (week 1 and week 5) where they will record their usual dietary intake over 3 days.
Consume an identical 3-day study meal plan during the test (calibration) diet week 3, whilst repeating the monitoring week measurements.
This study aims to recruit 133 adults living in Great Britain (GB) to better understand how these tools perform outside of a clinical environment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years and older
Lives in Great Britain (England, Schotland and Walse)
Able to read/understand instructions written in English and are fluent in English
Disqualifiers
Diagnosed or self-report as being underweight (have a body mass index (BMI) of less than 18.5 kg/m2)
Are unwilling/unable to collect urine and blood samples, use the wearable camera as instructed and/or spend 20-30 min online recording what they've recently had to eat/drink on multiple occasions
Are unwilling/unable to have a video call with a researcher with cameras turned on
Are unwilling/unable to post samples on specific days and receive/send a larger parcel at the start/end of the study (note: all return packaging and postage will be provided by us and will include a courier delivery and collection)
Trial population
UK population.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Measuring dietary intake
Other interventionDuring 5-week study, participants will monitor their usual dietary intake during two 3-day periods (on weeks 1 and 5). During week 3 (calibration week) participants will consume a test diet. Wearable camera technology, self-collected blood and urine samples, and online FFQ (eNutri) will be used to monitor food intake during study weeks. Study tools as well as foods/drinks for the test diet will be delivered to each participant and they will be asked to comply with the study procedures in their home or working environment. Participants will post study samples and the study equipment/logs at designated times using pre-paid envelopes or a courier collection, respectively.
Treatment groups
133 Participants
are divided into 1 treatment groupGroup A: Free-living adults living in GB1 intervention
Trial outcomes
Primary outcomes
1
Dietary intake measured by wearable camera technology.
Wearable cameras will be worn by the participants during the study days. Images from wearable cameras will be analysed to estimate what foods and drinks were consumed during the study days, as well as estimating their portion sizes (grams per day).
Time frame
Days 1- 3 (week 1), days 15-17 (week 3) and days 32-34 (week 5).2
Dietary intake measured by spot urine.
A range of biomarkers indicating what a person has eaten/drank will be measured in urine samples.
Time frame
Morning and evening spot urine samples collected over 4 consecutive days on weeks 1, 3 and 5 (days 1-4, 15-18, 32-35).3
Dietary intake measured by blood sample.
A range of food/drink biomarkers will be measured in capillary blood samples to indicate what a person has eaten/ drank.
Time frame
Samples collected at fasted state in the morning of days 4, 18 and 35 (weeks 1, 3 and 5).4
Monitoring/calibration week dietary intake (condensed 3-day FFQ).
Food/drink intake during the 3-day study periods will be measured by the 3-day condensed FFQ (adapted to capture foods not represented by biomarker analysis). Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
Time frame
Days 4, 18 and 35 (weeks 1, 3 & 5).Secondary outcomes
1
Habitual dietary intake (original eNutri FFQ).
Habitual intake will be measured by the original 4-week eNutri FFQ. Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
Time frame
Baseline.2
Habitual dietary intake (condensed original FFQ).
Habitual intake will be measured by the condensed 4-week eNutri. Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
Time frame
Baseline, after original eNutri FFQ.3
Calibration week dietary intake (3-day eNutri FFQ).
Food/drink intake during the 3-day calibration week ( week 3) will be measured by the 3-day FFQ. Outcomes include dietary intakes (frequency, portion size and grams per day) for each FFQ item, nutrient intakes, food group intakes and diet quality score.
Time frame
Day 18, week 3.4
Usability questionnaire for each research tool.
Short qualitative feedback questionnaire will be administered online via REDCap to determine participants' perspectives on usability of each study tool (including Likert scale questions "strongly disagree to strongly agree" and free text responses).
Time frame
Day 35, week 5.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Reading
Lead sponsor
Aberystwyth University
Collaborator
University of Cambridge
Collaborator
Imperial College London
Collaborator
Source ClinicalTrials.gov