Dietary ModificationEatWellEURNCT03897972
Study to Evaluate the 'eNutri' Online Personalised Nutrition App in the United Kingdom (UK)
A study testing Personalised diet advice delivered via the eNutri app (intervention) in people with Dietary Modification and Dietary Habits, run by University of Reading at 1 site in United Kingdom.
Trial summary
The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. 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 diet advice delivered via the eNutri app (intervention)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Aug 2019to Dec 2019
- 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
- Living in the UK
- Can understand written English
Who cannot join
- Food allergies or food intolerances (diagnosed or self-diagnosed)
- Receiving professional nutritional advice from a dietitian, nutritionist or medical professional
- Following a specialised diet (e.g. vegan, calorie-controlled/weight-loss diet)
- Athletes or those following a or sports nutrition regimen
- Pregnant, lactating or planning a pregnancy within the next 3 months
- Diagnosed medical conditions that require specific dietary guidance (e.g. diabetes, Crohn's disease or eating disorders), those who are currently undergoing rigorous medical treatment (e.g. chemotherapy for cancer) or conditions that affect memory (e.g. dementia)
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- Medications that impact on diet (e.g. weight-loss medication) or involve dietary restrictions
- Those who eat less than 2 meals per day
- Excessive use of herbal or dietary supplements (e.g. 3 or more per day)
- Taking part in another nutrition study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, RG6 6AP
About this study
Official title: Proof-of-principle Pilot Study to Investigate Whether Online Personalised Dietary Advice Given by the eNutri Diet App Encourages Greater Dietary Behaviour Change Than General Advice in UK Adults After 12 Weeks
The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12.
Read the detailed description
The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Both groups will receive two prompts to remind them of their diet advice at weeks 4 and 8. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12. 98 participants will be recruited per study arm and will be randomly allocated to an intervention arm using a minimisation technique integrated with the eNutri app.
- Conditions
- Dietary Modification, Dietary Habits
- Being tested
- Non-personalised diet advice delivered via the eNutri app (control), Personalised diet advice delivered via the eNutri app (intervention)
- Keywords
- Personalised nutrition
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-personalised diet advice delivered via the eNutri app (control)Behavioural
Non-personalised dietary advice to improve food choices based on standard population guidelines delivered by the eNutri app and irrespective of the dietary intakes from the food frequency questionnaire (control group).
Personalised diet advice delivered via the eNutri app (intervention)Behavioural
Personalised dietary advice to improve food choices based on adherence to an 11-item diet quality score, which is determined by the eNutri app in response to the dietary intakes from the food frequency questionnaire (intervention group).
| Study group | Role | What they receive |
|---|---|---|
| Non-personalised general diet advice | Active comparator | Control group to receive non-personalised dietary advice based on general public health dietary recommendations for Northern Europe. Advice will be delivered to the participant via the eNutri web application. Receives: Behavioral: Non-personalised diet advice delivered via the eNutri app (control) |
| Personalised diet advice | Experimental | Intervention group to receive personalised dietary advice generated by the eNutri app from their actual dietary intakes and tailored according to their body mass index and food preferences. Advice will be delivered to the participant via the eNutri app web application and will be generated based on their adherence to an 11-item diet quality score suitable for Northern European populations. Receives: Behavioral: Personalised diet advice delivered via the eNutri app (intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
eNutri diet quality score (DQS)
Dietary intake at baseline and week 12 will be assessed via the eNutri food frequency questionnaire (FFQ) from which an 11-item eNutri DQS will be calculated. The eNutri DQS was developed for Northern Europe and quantifies diet quality (i.e. the healthiness of a diet). It is composed of 11 food and nutrient components (contributing 10 points each) that are summed to give an overall score (between 0-110 points), where higher scores reflect the healthiest diets based on adherence to dietary recommendations.
Measured: Baseline & week 12
Secondary outcomes (1)
Body mass index (BMI)
Self reported measurements of weight and height will be used to determine BMI.
Measured: Baseline & week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start5 Aug 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897972
- Sponsor's protocol ID
- 08/19
- Acronym
- EatWellEUR
- Status last verified
- Nov 2019
- First submitted
- 29 Mar 2019
- Last updated
- 29 Nov 2019
- 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 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-principle Pilot Study to Investigate Whether Online Personalised Dietary Advice Given by the eNutri Diet App Encourages Greater Dietary Behaviour Change Than General Advice in UK Adults After 12 Weeks
- ClinicalTrials.gov ID
- NCT03897972
- Acronym / sponsor ID
- EatWellEUR / 08/19
- Conditions
- Dietary Modification, Dietary Habits
- Keywords
- Personalised nutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Apr 2019 (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 proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12.
Detailed description
The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Both groups will receive two prompts to remind them of their diet advice at weeks 4 and 8. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12. 98 participants will be recruited per study arm and will be randomly allocated to an intervention arm using a minimisation technique integrated with the eNutri app.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-personalised general diet advice | Active comparator | Behavioral: Non-personalised diet advice delivered via the eNutri app (control)Control group to receive non-personalised dietary advice based on general public health dietary recommendations for Northern Europe. Advice will be delivered to the participant via the eNutri web application. |
| Personalised diet advice | Experimental | Behavioral: Personalised diet advice delivered via the eNutri app (intervention)Intervention group to receive personalised dietary advice generated by the eNutri app from their actual dietary intakes and tailored according to their body mass index and food preferences. Advice will be delivered to the participant via the eNutri app web application and will be generated based on their adherence to an 11-item diet quality score suitable for Northern European populations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Living in the UK
- Can understand written English
Key exclusion criteria (10 listed)
- Food allergies or food intolerances (diagnosed or self-diagnosed)
- Receiving professional nutritional advice from a dietitian, nutritionist or medical professional
- Following a specialised diet (e.g. vegan, calorie-controlled/weight-loss diet)
- Athletes or those following a or sports nutrition regimen
- Pregnant, lactating or planning a pregnancy within the next 3 months
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 |
|---|---|---|
| Non-personalised diet advice delivered via the eNutri app (control)Non-personalised dietary advice to improve food choices based on standard population guidelines delivered by the eNutri app and irrespective of the dietary intakes from the food frequency questionnaire (control group). | Behavioural | Non-personalised general diet advice |
| Personalised diet advice delivered via the eNutri app (intervention)Personalised dietary advice to improve food choices based on adherence to an 11-item diet quality score, which is determined by the eNutri app in response to the dietary intakes from the food frequency questionnaire (intervention group). | Behavioural | Personalised diet advice |
Primary outcome
eNutri diet quality score (DQS)
Time frame: Baseline & week 12
Dietary intake at baseline and week 12 will be assessed via the eNutri food frequency questionnaire (FFQ) from which an 11-item eNutri DQS will be calculated. The eNutri DQS was developed for Northern Europe and quantifies diet quality (i.e. the healthiness of a diet). It is composed of 11 food and nutrient components (contributing 10 points each) that are summed to give an overall score (between 0-110 points), where higher scores reflect the healthiest diets based on adherence to dietary recommendations.
1 secondary outcome
Body mass index (BMI)
Time frame: Baseline & week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Individual participant dataSharing planned: No
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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
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 diet advice delivered via the eNutri app (intervention) 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 2 inclusion and 10 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 29 Nov 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. 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?
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 diet quality score (DQS) (time frame: Baseline & week 12). 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 29 Nov 2019.