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Completed

NCT Number: NCT04761575

Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Reading

Reading, Berkshire, RG6 6DZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validation of the FFQ65+ via eNutri app

Other

All participants will provide two eNutri FFQ datasets within a 14-day interval along with three 24-hour dietary recalls and dried blood spot samples.

Primary outcomes

  1. eNutri dietary intake

    Time frame: Baseline

    eNutri FFQ1 dietary data

Secondary outcomes

  1. eNutri dietary intake

    Time frame: Day 14

    eNutri FFQ2 dietary data

Other outcomes

  1. 24-hour dietary recall intake

    Time frame: Baseline

    Self-reported 24-hour dietary intake using Intake24 on three randomly allocated days within 14 days

  2. Dried blood spot biomarkers

    Time frame: Baseline

    Dried blood spots analysed for selected biomarkers such as markers of health (e.g. cholesterol) and dietary intake (e.g. carotenoids).

  3. Height

    Time frame: Baseline

    Self-reported measurement of height

  4. Weight

    Time frame: Baseline

    Self-reported measurement of weight

  5. Weight

    Time frame: Day 14

    Self-reported measurement of weight

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

Validation and Reproducibility Study of the eNutri Online Food Frequency Questionnaire for UK Adults Aged 65 Years and Older

Acronym: eNutriFFQ65+

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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