Clinical trial NCT04761575: Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older
Official title: Validation and Reproducibility Study of the eNutri Online Food Frequency Questionnaire for UK Adults Aged 65 Years and Older
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Habit
Keywords: Food frequency questionnaire
Nutrition
Dietary intake
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 91
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults aged 65 and over who live in the UK

Brief summary: The aim is to determine whether the eNutri web application can effectively estimate the dietary intake of a UK older population. The eNutri FFQ65+ study will validate the eNutri online food frequency questionnaire (FFQ) using 100 adults aged 65+ years. The FFQ will be validated against an online 24-hour dietary recall system (Intake24) and its reproducibility will be evaluated by the completion of two FFQs within a 14-day interval. In addition, all participants will also be asked to provide dried blood spot (DBS) samples which will be analysed for key biomarkers of nutritional intake and health. Biomarker results will be compared to FFQ results to further validate the eNutri FFQ.

Detailed description: The primary objective of this study is to validate the eNutri FFQ65+ that assesses dietary intake for the previous 4 weeks against a widely-used, validated computer based 24-hour dietary recall system (Intake24), which is the dietary assessment tool currently used by the UK's National Diet and Nutrition Survey Rolling Programme. The second objective, the reproducibility of the FFQ 65+ dietary data, will also be tested by asking participants to complete the eNutri FFQ on two separate occasions with a 14-day interval between both. In addition, after completing the first FFQ, DBS will be collected from all participants to further validate the FFQ results against selected biomarkers, for example markers of nutrient intake, such as carotenoids, and markers of health, such as cholesterol.

Eligibility criteria: Inclusion Criteria:

* Aged 65 years or over
* Live in the UK
* Able to spend approximately 30 minutes using a screen on a device
* Do not have a diagnosis of dementia or another condition affecting memory
* Do not have a food allergy or food intolerance (self- or medically diagnosed)
* Are not following a weight loss diet
* Generally eat on 2 or more occasions everyday

Exclusion Criteria:

* Follow a specialised or restricted diet (not including vegan and vegetarian diets)
* Have a medical condition or take medications that do not allow an individual to eat a stable diet on a day-to-day basis (e.g. severe gastrointestinal condition)
* Anticipate changes to their diet within the next three weeks (e.g. surgery, holiday, receiving nutritional advice from a professional)
* Have participated in another nutrition study that included a specific dietary regime in the last 4 weeks or are currently participating

Primary outcomes:
measure: eNutri dietary intake
timeFrame: Baseline
Secondary outcomes:
measure: eNutri dietary intake
timeFrame: Day 14
Other outcomes:
measure: 24-hour dietary recall intake
timeFrame: Baseline
measure: Dried blood spot biomarkers
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: Day 14
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
affiliation: Hugh Sinclair Unit of Human Nutrition, University of Reading
name: Julie Lovegrove, Professor
role: PRINCIPAL_INVESTIGATOR
References: