Validation of the eNutri Food Frequency Questionnaire for... | NCT04761575

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

NCT04761575

Sponsor

University of Reading

Status

Completed

Last Update Posted

Apr 14, 2023Actual

Enrollment

91Actual

Phase

Not provided

Conditions

Diet Habit

Interventions

Validation of the FFQ65+ via eNutri app

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 21, 2021Actual

Primary Completion Date

Nov 22, 2021Actual

Completion Date

Nov 22, 2021Actual

First Submitted Date

Feb 12, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2023

Last Update Posted Date

Apr 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FFQ validation		All participants to complete all aspects of the study.	Other: Validation of the FFQ65+ via eNutri app

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
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).

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Adults aged 65 and over who live in the UK

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Lovegrove, Professor	Hugh Sinclair Unit of Human Nutrition, University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Reading		Reading	Berkshire	RG6 6DZ	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

Not provided

Time Frame

Data available at the end of the project.

Access Criteria

Will depend on FNS-Cloud access criteria (https://www.fns-cloud.eu/) - to be decided by the consortium.

URL

Not provided

ID	Term
D005247	Feeding Behavior

ID	Term
D001522	Behavior, Animal
D001519	Behavior

Description

Dried blood spots will be collected from participants but will not be used to extract DNA. The dried blood spots will be used to validate the FFQ against selected biomarkers such as markers of health (e.g. cholesterol) and markers of nutrient intake (e.g. carotenoids).