Diet HabitNCT05612997
ZOE-AFFIRM: Relative Validation of a Novel Food Frequency Questionnaire
An observational study of Diet Habit, run by King's College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Dietary Assessment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Nov 2022to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: United Kingdom-based adult population who have subscribed to the ZOE Product waitlist.
Who may be able to join
- 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
Who cannot join
- Do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Inbar Linenberg, MS contact
About this study
Official title: 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.
Read the 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.
- 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.
- 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
- Diet Habit
- Being tested
- Dietary Assessment
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary AssessmentOther
Food Frequency Questionnaire and 24h Recalls.
| Study group | Role | What they receive |
|---|---|---|
| Relative Validation Arm | Not described Receives: Other: Dietary Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Frequency Questionnaire
Measured: 30 days
24h Recalls
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start8 Nov 2022 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Zoe Global Limited
- Responsible party
- Sponsor
- Investigators
- Sarah E Berry, PhD, Principal investigator, King's College London and Consultant at ZOE Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612997
- Sponsor's protocol ID
- ZOE-AFFIRM
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Validation of a Remote Novel Food Frequency Questionnaire Compared to 24hr Recalls in the ZOE AFFIRM Study
- ClinicalTrials.gov ID
- NCT05612997
- Acronym / sponsor ID
- ZOE-AFFIRM
- Conditions
- Diet Habit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Zoe Global Limited
- Study start
- 8 Nov 2022 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relative Validation Arm | – | Other: Dietary Assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- United Kingdom-based adult population who have subscribed to the ZOE Product waitlist.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary AssessmentFood Frequency Questionnaire and 24h Recalls. | Other | Relative Validation Arm |
Primary outcome
Food Frequency Questionnaire
Time frame: 30 days
24h Recalls
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Diet Habit
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
Not yet recruiting
Project GAME ON! A Digital Comic Tool to Promote Healthy Behaviors
Obesity & Overweight, Childhood
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
Recruiting
Can Food Timing Reduce Your Diabetes Risk?
Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inbar Linenberg, MS contact
Sarah E Berry, PhD principal investigator
King's College London and Consultant at ZOE Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily R Leeming, PhD (07791131380, emily.leeming@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Food Frequency Questionnaire (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.