Study to Evaluate the 'eNutri' Online Personalised Nutrition App in the United Kingdom (UK) (EatWellEUR)

Proof-of-principle Pilot Study to Investigate Whether Online Personalised Dietary Advice Given by the eNutri Diet App Encourages Greater Dietary Behaviour Change Than General Advice in UK Adults After 12 Weeks

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.

Study Overview

• Status: Unknown
• Conditions: Dietary Habits; Dietary Modification
• Intervention / Treatment: Behavioral: Non-personalised diet advice delivered via the eNutri app (control); Behavioral: Personalised diet advice delivered via the eNutri app (intervention)

Detailed Description

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. Both groups will receive two prompts to remind them of their diet advice at weeks 4 and 8. 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. 98 participants will be recruited per study arm and will be randomly allocated to an intervention arm using a minimisation technique integrated with the eNutri app.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AP
      • Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Living in the UK
• Can understand written English

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-personalised general diet advice; 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); 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).
Experimental: Personalised diet advice; 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); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	Self reported measurements of weight and height will be used to determine BMI.	Baseline & week 12

Collaborators and Investigators

• Sponsor: University of Reading
• Investigators: Principal Investigator: Julie Lovegrove, Professor, Hugh Sinclair Unit of Human Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Personalised nutrition
• Other Study ID Numbers: 08/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No