ZOE-AFFIRM: Relative Validation of a Novel Food Frequency Questionnaire

NCT ID: NCT05612997

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-08

Study Completion Date

2022-12-20

Brief Summary

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Dietary assessment is critical for dietary research. Food Frequency Questionnaires (FFQ) measure habitual dietary intake and are low user and researcher burden. The ZOE AFFIRM study aims to assess the relative validity of a novel FFQ compared to a widely accepted 24h dietary recall tool in a remote setting.

Detailed Description

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Research Question:

What is the relative validity of a novel FFQ (Food Frequency Questionnaire) compared to a widely accepted 24h dietary recall tool in a remote setting?

Research Aim:

This study aims to relatively validate the ZFFQ (ZOE Food Frequency Questionnaire; ZOE Ltd) by assessing its agreement with a widely accepted 24h diet recall tool, Intake24 (Newcastle University) in a remote population.

Design:

This study will be conducted in a single-arm design with the intake period under assessment comprising one month.

1. Participants will complete two periods of 3 consecutive days each (one weekend-day and two weekdays, i.e. Sunday-Tuesday or Thursday-Saturday), in which they will complete 6 total rounds of Intake24 (one completion per previous 24 hours). The two periods must be at least 14 days apart; participants will be given multiple options of dates to choose from in November/December that satisfy these requirements.
2. Once the two recall periods are completed, the participant will be asked to fill out the ZFFQ recalling food frequency (without portion sizes) over the preceding month (which encompasses the two recall periods).

Population: In brief, participants are generally healthy UK-based adults who provided consent to participation in this remote study. Please see the eligibility section for full criteria. Participants provided consent before undertaking any study procedures.

Data analysis: Agreement analysis will be used to compare both dietary assessment methods and evaluate the relative validity of the ZOE FFQ.

Data collection:

* Baseline demographic data (age, sex, BMI, ethnicity, smoking, socio-economic status)
* Dietary data (FFQ and 24hr dietary recall)

Conditions

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Diet Habit

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Relative Validation Arm

Dietary Assessment

Intervention Type OTHER

Food Frequency Questionnaire and 24h Recalls.

Interventions

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Dietary Assessment

Food Frequency Questionnaire and 24h Recalls.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Can provide written informed consent
* Are willing and able to comply with all study protocols
* Are willing to complete their dietary recall periods on specified dates
* Have BMI 18 and above
* Are any sex
* Are aged 18 years old and above
* Live in England, Scotland, Wales or Northern Ireland
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zoe Global Limited

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah E Berry, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London and Consultant at ZOE Ltd

Locations

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ZOE Ltd.

London, , United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Emily R Leeming, PhD

Role: CONTACT

07791131380

Inbar Linenberg, MS

Role: CONTACT

Other Identifiers

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ZOE-AFFIRM

Identifier Type: -

Identifier Source: org_study_id

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