Online Nutrition Advice in the UK (EatWellUK)

Study Overview
=================
Brief 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. 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).

Official Title
-----------------
Randomized Control Trial to Evaluate the Effectiveness of Online Nutrition Advice in the UK (The EatWellUK Study)

Conditions
-----------------
Dietary Modification, Dietary Habits

Intervention / Treatment
-----------------
* Behavioral: Personalised advice
* Behavioral: Non-personalised advice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged > 18 years old Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Non-personalised advice<br>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). | Behavioral: Non-personalised advice<br>* 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.<br>|
| Experimental: Personalised advice<br>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. | Behavioral: Personalised advice<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | baseline, 6 weeks, 12 weeks | 
| Physical activity | Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks | baseline, 6 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Personalised nutrition, Mobile web application