NCT03396263

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

January 4, 2018

Last Update Submit

March 22, 2019

Conditions

Dietary ModificationDietary Habits

Keywords

Personalised nutritionMobile web application

Outcome Measures

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.

    baseline, 6 weeks, 12 weeks

Secondary Outcomes (2)

  • Weight

    baseline, 6 weeks, 12 weeks

  • Physical activity

    baseline, 6 weeks, 12 weeks

Study Arms (3)

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.

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).

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).

Behavioral: Non-personalised advice

Interventions

Non-personalised adviceBEHAVIORAL

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.

Control
Online personalised adviceBEHAVIORAL

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.

Online personalised advice
Face-to-face personalised adviceBEHAVIORAL

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.

Face-to-face personalised advice

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged \> 21 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dasman Diabetes Institute

Kuwait City, Kuwait

Location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Julie A Lovegrove

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 10, 2018

Study Start

December 24, 2017

Primary Completion

September 3, 2018

Study Completion

October 22, 2018

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

KU(1)GB(1)