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

March 22, 2019 updated by: Julie Lovegrove, University of Reading

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged > 21 years

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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).
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.
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).
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2017

Primary Completion (Actual)

September 3, 2018

Study Completion (Actual)

October 22, 2018

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 22, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 13/17b

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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