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

Diet Habit Clinical Trial

— eNutriFFQ65+  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04761575
• Other study ID #: 20/40
• Status: Completed
• Start date: April 21, 2021
• Est. completion date: November 22, 2021

Study information

• Verified date: April 2023
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit

Intervention

Other:
• Validation of the FFQ65+ via eNutri app
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.

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	24-hour dietary recall intake	Self-reported 24-hour dietary intake using Intake24 on three randomly allocated days within 14 days	Baseline
Other	Dried blood spot biomarkers	Dried blood spots analysed for selected biomarkers such as markers of health (e.g. cholesterol) and dietary intake (e.g. carotenoids).	Baseline
Other	Height	Self-reported measurement of height	Baseline
Other	Weight	Self-reported measurement of weight	Baseline
Other	Weight	Self-reported measurement of weight	Day 14
Primary	eNutri dietary intake	eNutri FFQ1 dietary data	Baseline
Secondary	eNutri dietary intake	eNutri FFQ2 dietary data	Day 14