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

November 4, 2022 updated by: King's College London

Relative Validation of a Remote Novel Food Frequency Questionnaire Compared to 24hr Recalls in the ZOE AFFIRM Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

United Kingdom-based adult population who have subscribed to the ZOE Product waitlist.

Description

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

Exclusion Criteria:

- Do not meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Relative Validation Arm
Other: Dietary Assessment
Food Frequency Questionnaire and 24h Recalls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Food Frequency Questionnaire
Time Frame: 30 days
30 days
24h Recalls
Time Frame: 6 days
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Zoe Global Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 8, 2022

Primary Completion (ANTICIPATED)

December 20, 2022

Study Completion (ANTICIPATED)

December 20, 2022

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (ACTUAL)

November 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ZOE-AFFIRM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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