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

Dietary Habits Clinical Trial

— EatWellEUR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03897972
• Other study ID #: 08/19
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: December 2019

Study information

• Verified date: November 2019
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 216
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Habits
• Dietary Modification

Intervention

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).
• 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).

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body mass index (BMI)	Self reported measurements of weight and height will be used to determine BMI.	Baseline & week 12