Dietary ModificationEatWellQ8NCT03396263
Online vs. Face-to-face Nutritional Advice in Kuwait (EatWellQ8)
A study testing Non-personalised advice, Online personalised advice and Face-to-face personalised advice in people with Dietary Modification and Dietary Habits, run by University of Reading at 2 sites in 2 countries.
Trial summary
The EatWellQ8 study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, compared with face-to-face nutritional advice, in increasing diet quality. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification, Dietary Habits
- What is being tested?
- Non-personalised advice, Online personalised advice and Face-to-face personalised advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Dec 2017to 22 Oct 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged > 21 years
Who cannot join
- aged < 21 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Control Trial to Evaluate the Effectiveness of Online Versus Face-to-face Nutrition Advice in Kuwait (The EatWellQ8 Study)
The EatWellQ8 study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, compared with face-to-face nutritional 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
- Non-personalised advice, Online personalised advice, Face-to-face 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.
Non-personalised adviceBehavioural
Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalised dietary advice for improved food choice based on standard population health guidelines.
Online 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.
Face-to-face personalised adviceBehavioural
Provision of face-to-face 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.
| Study group | Role | What they receive |
|---|---|---|
| Online 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: Online personalised advice |
| Face-to-face personalised advice | Experimental | Face-to-face 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 nutritional advice face-to-face (in person or via video chat). Receives: Behavioral: Face-to-face personalised advice |
| Control | Placebo comparator | Non-personalised advice Control group. Online (web-based) delivery of non- personalised dietary, weight and physical activity advice based on the UK general health guidelines. 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary change
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 posted10 Jan 2018
- Study start24 Dec 2017
- Primary completion3 Sep 2018
- Study completion22 Oct 2018
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
- None (open label)
- Enrolment
- 320 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
- NCT03396263
- Sponsor's protocol ID
- 13/17b
- Acronym
- EatWellQ8
- Status last verified
- Mar 2019
- First submitted
- 4 Jan 2018
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 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 Versus Face-to-face Nutrition Advice in Kuwait (The EatWellQ8 Study)
- ClinicalTrials.gov ID
- NCT03396263
- Acronym / sponsor ID
- EatWellQ8 / 13/17b
- Conditions
- Dietary Modification, Dietary Habits
- Keywords
- Personalised nutrition, Mobile web application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 24 Dec 2017 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 10 Jan 2018 (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 EatWellQ8 study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, compared with face-to-face nutritional 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Online personalised advice | Experimental | Behavioral: Online 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. |
| Face-to-face personalised advice | Experimental | Behavioral: Face-to-face personalised adviceFace-to-face 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 nutritional advice face-to-face (in person or via video chat). |
| Control | Placebo comparator | Behavioral: Non-personalised adviceNon-personalised advice Control group. Online (web-based) delivery of non- personalised dietary, weight and physical activity advice based on the UK general health guidelines. This arm will be using the e-Nutri web application. Participants in this group will receive online general recommendations (non- personalised). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged > 21 years
Key exclusion criteria (7 listed)
- aged < 21 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 |
|---|---|---|
| Non-personalised adviceProvision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalised dietary advice for improved food choice based on standard population health guidelines. | Behavioural | Control |
| Online 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 | Online personalised advice |
| Face-to-face personalised adviceProvision of face-to-face 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 | Face-to-face personalised advice |
Primary outcome
Dietary change
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 25 Mar 2019.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-personalised advice, Online personalised advice and Face-to-face personalised advice in people with Dietary Modification and Dietary Habits, run by University of Reading at 2 sites in 2 countries.
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 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kuwait, 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 change (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?
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 25 Mar 2019.