- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03396263
Online vs. Face-to-face Nutritional Advice in Kuwait (EatWellQ8) (EatWellQ8)
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
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kuwait City, Kuwait
- Dasman Diabetes Institute
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-
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Berkshire
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Reading, Berkshire, United Kingdom, RG6 6AP
- University of Reading
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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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).
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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.
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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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary change
Time Frame: baseline, 6 weeks, 12 weeks
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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.
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baseline, 6 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: baseline, 6 weeks, 12 weeks
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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).
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baseline, 6 weeks, 12 weeks
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Physical activity
Time Frame: baseline, 6 weeks, 12 weeks
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Change from baseline in self-reported physical activity (Baecke questionnaire) at 6 and 12 weeks
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baseline, 6 weeks, 12 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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