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CompletedNCT03396263EatWellQ8Updated Mar 25, 2019

Online vs. Face-to-face Nutritional Advice in Kuwait (EatWellQ8)

An interventional study of Non-personalised advice and Online personalised advice in Dietary Modification and Dietary Habits, sponsored by University of Reading. Completed at 2 sites in 2 countries. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-25.

Sponsored by University of Reading · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
320
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Dietary Modification
  • Dietary Habits

Keywords

  • Personalised nutrition
  • Mobile web application
03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • aged > 21 years

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
320 participants (actual)

Study arms

  • Experimental
    Online personalised advice

    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: Online personalised advice

  • Experimental
    Face-to-face personalised advice

    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).

    Behavioral: Face-to-face personalised advice

  • Placebo comparator
    Control

    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).

    Behavioral: Non-personalised advice

Interventions

  • BehavioralNon-personalised advice

    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.

  • BehavioralOnline personalised advice

    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.

  • BehavioralFace-to-face personalised advice

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 6 weeks, 12 weeks

Secondary outcomes

  1. 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).

    Time frame: baseline, 6 weeks, 12 weeks

  2. Physical activity

    Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks

    Time frame: baseline, 6 weeks, 12 weeks

06

Study locations

2 sites
  • Dasman Diabetes Institute
    Kuwait City, Kuwait
  • University of Reading
    Reading, Berkshire RG6 6AP, United Kingdom
07

Registry details

Key details

Study ID
NCT03396263
Lead sponsor
University of Reading
Responsible party
Julie Lovegrove (Professor Julie A Lovegrove, University of Reading) — Principal investigator
First posted
Jan 10, 2018
Start date
Dec 24, 2017
Primary completion
Sep 3, 2018
Completion
Oct 22, 2018
Last update
Mar 25, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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