University of Reading
Julie Lovegrove
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 UK adults to better understand how these tools perform outside of a clinical environment.
Dietary Intake Assessment
Food Intake Measurement
Measuring dietary intake
The SODIAT project is a collaborative effort involving Aberystwyth University (AberU, project lead), University of Reading (UoR), Imperial College London (Imperial), and the University of Cambridge (UoC). Study 1, completed in July 2024, assessed the effectiveness of objective and subjective dietary intake assessment methods in highly-controlled clinical trial (protocol published at https://doi.org/10.12688/f1000research.155683.1) and informed the design of study 2. Study 2 is led and sponsored by UoR. All study activities will be conducted remotely, with participants taking part from their usual locations (e.g., home, work). ►Screening and Welcome Week Participants will use the online REDCap research platform to provide informed consent and complete a screening questionnaire to determine eligibility. Eligible participants will be contacted by a study researcher to discuss the study requirements, confirm consent, and schedule the study period. A week before starting the 5-week study (Welcome Week), participants will be sent study materials/equipment and will be referred to the SODIAT webpage to view online video tutorials and read user guidelines for each study tool. Afterwards, participants will attend a video call with a study researcher to familiarize them with the study protocol and provide an opportunity to ask questions. During the Welcome Week, participants will also self-collect a baseline blood sample (pre-video call) and complete the online eNutri FFQ to assess habitual diet. Within 2 days, they will then complete a condensed version of the FFQ to evaluate its effectiveness in estimating diet quality with reduced participant burden. ►5-week study period Participants will follow their usual diet during weeks 1 \& 5 and record their diet using study tools (wearable cameras, blood samples, urine samples and online FFQ) for 3 consecutive days (Monitoring Weeks). During week 3 (Calibration Week), participants will use the same study tools as before whilst consuming the 3-day test diet. There will be two test diets (one diet for meat/fish consumers and another slightly adapted for non-consumers), consisting of foods and drinks that are common in the UK. During this controlled part of the study, participants will be requested to eat/drink all foods and drinks provided (delivered by an online supermarket) but cannot consume anything extra. They will receive recommendations on serving sizes for each food/drink but participants can choose how much they eat (either more or less). ►Wearable cameras Participants will wear a small camera unit mounted on glasses (or attached to their own frames) during the 3-day periods of weeks 1, 3, and 5 (days 1-3; 15-17 and 32-34). The camera automatically captures still images every 15 seconds to document food and drink intake. The camera will be worn from waking to going to bed, although participants will be instructed to remove the camera during private times (e.g., bathroom), sensitive locations (e.g., changing rooms, GP surgeries) and if unsafe to wear (e.g., driving), and log these occasions, as well as the camera start time, on a paper-based log. At the end of the study, encrypted SD cards containing the images will be returned to the research team at Imperial for secure processing. Images will be pre-processed using AI to exclude irrelevant images, and blur identifying details (e.g., faces, device screens). Only anonymised images will be analysed by researchers to estimate dietary intake. ►Capillary blood samples When fasted, participants will self-collect blood samples using OneDraw kits on day 4 of each study week (day 4, 18 and 35), which collect a few drops of blood from the upper arm/thigh onto a filter paper cartridge. A baseline sample will also be collected during the Welcome Week. Instructions and video tutorials will be provided, and samples will be mailed to researchers at UoC for storage and biomarker analysis. ►Spot urine samples Over 4 consecutive days of each study week (days 1-4, 15-18, 32-35), participants will collect first morning void and last evening void urine samples using straw and vacuum tube kits. Samples will be temporarily stored in a refrigerator before mailing them to AberU for processing where biomarkers of food and drink intake will be analysed. ►Online FFQ (eNutri) Participants will complete the online eNutri FFQ on six occasions. Both the original (long-format) and condensed FFQ will be completed during Welcome Week to capture habitual intake during the previous 4 weeks. During the study, a 3-day, condensed FFQ adapted to capture foods/drinks not well-represented by biomarker analysis, will be completed at the end of each recording week (day 4, 18 and 35). During the test diet week, the original FFQ, adapted to capture 3-day intakes, will also be completed (day 18). The FFQ inputs, nutrient and food group intakes, and diet quality data will be exported in pseudonymised format for analysis. At the study's conclusion, participants will complete a short, online usability questionnaire about the study tools via REDCap (day 35). Participants will mail their SD cards, blood samples, and urine samples at designated timepoints using pre-paid postage. Researchers will monitor adherence and communicate with participants as needed. Daily reminders will also be sent via email or text (SMS) message during the recording days. ► Statistical analysis Accuracy of integrating multiple dietary assessment technologies to report dietary intake in free living environments will be measured during the calibration week (week 3) using dietary intake data collected from wearable cameras, spot urine samples, capillary blood samples, and self-reported FFQs.
Study Type : | OBSERVATIONAL |
Estimated Enrollment : | 133 participants |
Official Title : | Investigating a Data-driven Standardized and Objective Dietary Intake Assessment Tool in Free-living Individuals - SODIAT-2 Study |
Actual Study Start Date : | 2025-05 |
Estimated Primary Completion Date : | 2026-04 |
Estimated Study Completion Date : | 2026-04 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Hugh Sinclair Unit of Human Nutrition, University of Reading
Reading, Berkshire, United Kingdom, RG6 6DZ
Not yet recruiting
Department of Life Sciences, Aberystwyth University
Aberystwyth, United Kingdom, It will fall several
Not yet recruiting
University of Cambridge, Pathology building level 4, Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Not yet recruiting
Nutrition Research Section, Hammersmith Hospital Campus, Imperial College
London, United Kingdom, W12 0NN