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

Diet Habit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05612997
• Other study ID #: ZOE-AFFIRM
• Status: Not yet recruiting
• Start date: November 8, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: October 2022
• Source: King's College London
• Contact: Emily R Leeming, PhD
• Phone: 07791131380
• Email: emily.leeming[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diet Habit

Intervention

Other:
• Dietary Assessment
Food Frequency Questionnaire and 24h Recalls.

Locations

Country	Name	City	State
United Kingdom	ZOE Ltd.	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Zoe Global Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Frequency Questionnaire		30 days
Primary	24h Recalls		6 days