Diet HabiteNutriFFQ65+NCT04761575
Validation of the eNutri Food Frequency Questionnaire for Adults Aged 65 y and Older
An observational study of Diet Habit, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- What is being tested?
- Validation of the FFQ65+ via eNutri app
- How many people
- 91 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to 22 Nov 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults aged 65 and over who live in the UK
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Reproducibility Study of the eNutri Online Food Frequency Questionnaire for UK Adults Aged 65 Years and Older
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.
Read the 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.
- Conditions
- Diet Habit
- Being tested
- Validation of the FFQ65+ via eNutri app
- Keywords
- Food frequency questionnaire, Nutrition, Dietary intake
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of the FFQ65+ via eNutri appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| FFQ validation | All participants to complete all aspects of the study. Receives: Other: Validation of the FFQ65+ via eNutri app |
What is being measured
The primary outcome is the main question the study is designed to answer.
eNutri dietary intake
eNutri FFQ1 dietary data
Measured: Baseline
Secondary outcomes (1)
eNutri dietary intake
eNutri FFQ2 dietary data
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start21 Apr 2021
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
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.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Lovegrove, University of Reading
- Investigators
- Julie Lovegrove, Professor, Principal investigator, Hugh Sinclair Unit of Human Nutrition, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761575
- Sponsor's protocol ID
- 20/40
- Acronym
- eNutriFFQ65+
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Reproducibility Study of the eNutri Online Food Frequency Questionnaire for UK Adults Aged 65 Years and Older
- ClinicalTrials.gov ID
- NCT04761575
- Acronym / sponsor ID
- eNutriFFQ65+ / 20/40
- Conditions
- Diet Habit
- Keywords
- Food frequency questionnaire, Nutrition, Dietary intake
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 21 Feb 2021 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFQ validation | – | Other: Validation of the FFQ65+ via eNutri appAll participants to complete all aspects of the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults aged 65 and over who live in the UK
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Validation of the FFQ65+ via eNutri appAll participants will provide two eNutri FFQ datasets within a 14-day interval along with three 24-hour dietary recalls and dried blood spot samples. | Other | FFQ validation |
Primary outcome
eNutri dietary intake
Time frame: Baseline
eNutri FFQ1 dietary data
1 secondary outcome
eNutri dietary intake
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Yes. 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.
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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.
Julie Lovegrove, Professor principal investigator
Hugh Sinclair Unit of Human Nutrition, University of Reading
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 University of Reading 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 4 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: finished, as of the sponsor's last update on 14 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eNutri dietary intake (time frame: Baseline). 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 Apr 2023.