Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older (eNutriFFQ65+)

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

Study Overview

• Status: Completed
• Conditions: Diet Habit
• Intervention / Treatment: Other: Validation of the FFQ65+ via eNutri app

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6DZ
      • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 65 and over who live in the UK

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FFQ validation; All participants to complete all aspects of the study.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eNutri dietary intake	eNutri FFQ1 dietary data	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eNutri dietary intake	eNutri FFQ2 dietary data	Day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Self-reported measurement of weight	Baseline
Height	Self-reported measurement of height	Baseline
24-hour dietary recall intake	Self-reported 24-hour dietary intake using Intake24 on three randomly allocated days within 14 days	Baseline
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
Weight	Self-reported measurement of weight	Day 14

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Julie Lovegrove, Professor, Hugh Sinclair Unit of Human Nutrition, University of Reading

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): November 22, 2021
• Study Completion (Actual): November 22, 2021

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Nutrition; Food frequency questionnaire; Dietary intake
• Other Study ID Numbers: 20/40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers are part of the FNS-Cloud Consortium. Anonymised FFQ, 24h recall and DBS data will be on shared on FNS-Cloud (in development; https://www.fns-cloud.eu/) at the end of the project.
• IPD Sharing Time Frame: Data available at the end of the project.
• IPD Sharing Access Criteria: Will depend on FNS-Cloud access criteria (https://www.fns-cloud.eu/) - to be decided by the consortium.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No