Investigating a Data-driven Standardized and Objective Dietary Intake Assessment Tool in Free-living Individuals - SODIAT-2 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Dietary intake measured by wearable camera technology.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
- •Are unwilling/unable to receive a single grocery delivery from Sainsbury's or Tesco online supermarkets (delivery to be arranged by us), includes living in a postcode area that cannot receive grocery deliveries from Tesco or Sainsburys as well as not having space to refrigerate and freeze items.
- •Are unwilling/unable to eat/drink any items on the calibration menu, e.g., food allergies/intolerances, dislike of food items, unable eat (e.g. vegan or have to avoid for a medical condition) or cannot eat 3 meals plus snacks daily (note: vegetarians can take part)
- •Are unwilling/unable to avoid taking dietary and herbal supplements for at least 1 week before and during the 5-week study (e.g. fish oils, vitamins, iron, protein shakes, nutrient powders, joint care)
- •Are pregnant, may be pregnant or breast-feeding
- •Currently experiencing, recovering or at a high risk of an eating disorder (e.g., previous diagnosis, or concerns that you have an unhealthy relationship with food)
- •Have a health condition, are taking medication and/or undergoing medical treatment that affects metabolism, appetite and/or ability to eat the calibration menu (e.g. cancer, chemotherapy, diabetes, gastrointestinal disorders (such as inflammatory bowel disease, Crohn's disease), kidney disease, liver disease, HIV or AIDS)
- •Are taking any of the following medications: androgens, blood thinners, phenytoin, erythromycin, or thyroid hormones
- •Long-term use of any of the following medications: anti-inflammatories (NSAIDS), steroids/corticosteroids or antibiotics (eligible following a 4-week washout after short term use; eligible if use is infrequent)
- •Use illicit substances/recreational drugs
- •Have been diagnosed with dementia or other conditions affecting memory
- •Do not have anyone at home, work, etc. to help them if they require assistance to use the study tools (such as arthritis, Parkinson's disease, sight loss, etc.)
- •If the participants have recently taken part in another intervention study, a 4-week washout will be required before they are able to start the study.
研究组 & 干预措施
Free-living adults living in GB
The study aims to recruit 133 adults living in GB with BMI more than 18.5 kg/m2 who are fluent in English. Participants will monitor their usual dietary intake during two 3-day monitoring periods during weeks 1 and 5 by wearing camera technology, self-collecting blood and urine samples at designated times, and completing online food frequency questionnaire on multiple occasions. During the calibration week (week 3) participants will consume the same 3-day test diet (either the diet for meat/fish consumers or non-consumers, as identified at screening).
干预措施: Measuring dietary intake (Other)
结局指标
主要结局
Dietary intake measured by wearable camera technology.
时间窗: Days 1- 3 (week 1), days 15-17 (week 3) and days 32-34 (week 5).
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).
Dietary intake measured by spot urine.
时间窗: Morning and evening spot urine samples collected over 4 consecutive days on weeks 1, 3 and 5 (days 1-4, 15-18, 32-35).
A range of biomarkers indicating what a person has eaten/drank will be measured in urine samples.
Dietary intake measured by blood sample.
时间窗: Samples collected at fasted state in the morning of days 4, 18 and 35 (weeks 1, 3 and 5).
A range of food/drink biomarkers will be measured in capillary blood samples to indicate what a person has eaten/ drank.
Monitoring/calibration week dietary intake (condensed 3-day FFQ).
时间窗: Days 4, 18 and 35 (weeks 1, 3 & 5).
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.
次要结局
- Habitual dietary intake (original eNutri FFQ).(Baseline.)
- Habitual dietary intake (condensed original FFQ).(Baseline, after original eNutri FFQ.)
- Calibration week dietary intake (3-day eNutri FFQ).(Day 18, week 3.)
- Usability questionnaire for each research tool.(Day 35, week 5.)
研究者
Julie Lovegrove
Professor
University of Reading