NCT03897972

Brief Summary

The proof-of-principle EatWellEUR pilot study will investigate whether online personalised dietary advice encourages greater dietary behaviour change after 12 weeks compared with general population-based diet advice. Dietary change will be quantified from an 11-item diet quality score (DQS) suitable for Northern European populations that is calculated from the results of the eNutri food frequency questionnaire (FFQ) at baseline and week 12.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

4 months

First QC Date

March 29, 2019

Last Update Submit

November 27, 2019

Conditions

Keywords

Personalised nutrition

Outcome Measures

Primary Outcomes (1)

  • eNutri diet quality score (DQS)

    Dietary intake at baseline and week 12 will be assessed via the eNutri food frequency questionnaire (FFQ) from which an 11-item eNutri DQS will be calculated. The eNutri DQS was developed for Northern Europe and quantifies diet quality (i.e. the healthiness of a diet). It is composed of 11 food and nutrient components (contributing 10 points each) that are summed to give an overall score (between 0-110 points), where higher scores reflect the healthiest diets based on adherence to dietary recommendations.

    Baseline & week 12

Secondary Outcomes (1)

  • Body mass index (BMI)

    Baseline & week 12

Study Arms (2)

Non-personalised general diet advice

ACTIVE COMPARATOR

Control group to receive non-personalised dietary advice based on general public health dietary recommendations for Northern Europe. Advice will be delivered to the participant via the eNutri web application.

Behavioral: Non-personalised diet advice delivered via the eNutri app (control)

Personalised diet advice

EXPERIMENTAL

Intervention group to receive personalised dietary advice generated by the eNutri app from their actual dietary intakes and tailored according to their body mass index and food preferences. Advice will be delivered to the participant via the eNutri app web application and will be generated based on their adherence to an 11-item diet quality score suitable for Northern European populations.

Behavioral: Personalised diet advice delivered via the eNutri app (intervention)

Interventions

Non-personalised dietary advice to improve food choices based on standard population guidelines delivered by the eNutri app and irrespective of the dietary intakes from the food frequency questionnaire (control group).

Non-personalised general diet advice

Personalised dietary advice to improve food choices based on adherence to an 11-item diet quality score, which is determined by the eNutri app in response to the dietary intakes from the food frequency questionnaire (intervention group).

Personalised diet advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in the UK
  • Can understand written English

You may not qualify if:

  • Food allergies or food intolerances (diagnosed or self-diagnosed)
  • Receiving professional nutritional advice from a dietitian, nutritionist or medical professional
  • Following a specialised diet (e.g. vegan, calorie-controlled/weight-loss diet)
  • Athletes or those following a or sports nutrition regimen
  • Pregnant, lactating or planning a pregnancy within the next 3 months
  • Diagnosed medical conditions that require specific dietary guidance (e.g. diabetes, Crohn's disease or eating disorders), those who are currently undergoing rigorous medical treatment (e.g. chemotherapy for cancer) or conditions that affect memory (e.g. dementia)
  • Medications that impact on diet (e.g. weight-loss medication) or involve dietary restrictions
  • Those who eat less than 2 meals per day
  • Excessive use of herbal or dietary supplements (e.g. 3 or more per day)
  • Taking part in another nutrition study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Julie Lovegrove, Professor

    Hugh Sinclair Unit of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Hugh Sinclair Unit of Human Nutrition

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 1, 2019

Study Start

August 5, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations