Dietary ModificationEatWellUKNCT03250858
Online Nutrition Advice in the UK (EatWellUK)
A study testing Personalised advice and Non-personalised advice in people with Dietary Modification and Dietary Habits, run by University of Reading at 1 site in United Kingdom.
Trial summary
The EatWellUK study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet quality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Dietary Habits
- What is being tested?
- Personalised advice and Non-personalised advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Aug 2017to 30 Jan 2018
- Phase
- Interventional
- 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
Who may be able to join
- aged > 18 years old
Who cannot join
- aged < 18 years old
- not living in the UK
- pregnant/lactating
- no or limited access to internet
- following a prescribed diet for any reason
- intolerance or food allergy
- subject with diabetes, or any other metabolic disorder or illness that alters nutritional requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial to Evaluate the Effectiveness of Online Nutrition Advice in the UK (The EatWellUK Study)
The EatWellUK study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet quality.
Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).
- Conditions
- Dietary Modification, Dietary Habits
- Being tested
- Personalised advice, Non-personalised advice
- Keywords
- Personalised nutrition, Mobile web application
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised adviceBehavioural
Provision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.
Non-personalised adviceBehavioural
Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalized dietary advice for improved food choice based on standard population health guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Non-personalised advice | Placebo comparator | Control group. Online (web-based) delivery of non-personalised dietary, weight and physical activity advice based on the UK general health guidelines.
This is an online trial and this arm will be using the e-Nutri web application. Participants in this group will receive online general recommendations (non-personalised). Receives: Behavioral: Non-personalised advice |
| Personalised advice | Experimental | Online (web-based) delivery of personalised dietary, weight and physical activity advice based on the individual's dietary intake, weight and physical activity levels, generated by the e-Nutri web application. Participants in this group will receive online personalised reports. Receives: Behavioral: Personalised advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake
Change from baseline in dietary intake at 6 and 12 weeks assessed via a Food Frequency Questionnaire (FFQ). An 11-item modified US Alternative Healthy Eating Index (m-AHEI), which is calculated from the results of the FFQ, will be used to quantify the dietary intake changes.
Measured: baseline, 6 weeks, 12 weeks
Secondary outcomes (2)
Weight
Change from baseline in self-reported weight (kg) at 6 and 12 weeks. Weight variation will be combined with height (constant for adults) and also reported as BMI variation (kg/mˆ2).
Measured: baseline, 6 weeks, 12 weeks
Physical activity
Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks
Measured: baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start15 Aug 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary ModificationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250858
- Sponsor's protocol ID
- 13/17
- Acronym
- EatWellUK
- Status last verified
- Feb 2019
- First submitted
- 10 Aug 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.
PubMed 35468093
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial to Evaluate the Effectiveness of Online Nutrition Advice in the UK (The EatWellUK Study)
- ClinicalTrials.gov ID
- NCT03250858
- Acronym / sponsor ID
- EatWellUK / 13/17
- Conditions
- Dietary Modification, Dietary Habits
- Keywords
- Personalised nutrition, Mobile web application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 16 Aug 2017 (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 EatWellUK study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet quality.
Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-personalised advice | Placebo comparator | Behavioral: Non-personalised adviceControl group. Online (web-based) delivery of non-personalised dietary, weight and physical activity advice based on the UK general health guidelines. This is an online trial and this arm will be using the e-Nutri web application. Participants in this group will receive online general recommendations (non-personalised). |
| Personalised advice | Experimental | Behavioral: Personalised adviceOnline (web-based) delivery of personalised dietary, weight and physical activity advice based on the individual's dietary intake, weight and physical activity levels, generated by the e-Nutri web application. Participants in this group will receive online personalised reports. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged > 18 years old
Key exclusion criteria (7 listed)
- aged < 18 years old
- not living in the UK
- pregnant/lactating
- no or limited access to internet
- following a prescribed diet for any reason
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 |
|---|---|---|
| Personalised adviceProvision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results. | Behavioural | Personalised advice |
| Non-personalised adviceProvision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalized dietary advice for improved food choice based on standard population health guidelines. | Behavioural | Non-personalised advice |
Primary outcome
Dietary intake
Time frame: baseline, 6 weeks, 12 weeks
Change from baseline in dietary intake at 6 and 12 weeks assessed via a Food Frequency Questionnaire (FFQ). An 11-item modified US Alternative Healthy Eating Index (m-AHEI), which is calculated from the results of the FFQ, will be used to quantify the dietary intake changes.
2 secondary outcomes
Weight
Time frame: baseline, 6 weeks, 12 weeks
Physical activity
Time frame: baseline, 6 weeks, 12 weeks
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 6 Feb 2019.
- Derived from this study: PubMed 35468093Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalised advice and Non-personalised advice in people with Dietary Modification and Dietary Habits, 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 1 inclusion and 7 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 6 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Dietary intake (time frame: baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03250858, which also lists 1 linked publication.
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 6 Feb 2019.