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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897972
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading

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.

Condition or disease Intervention/treatment Phase
Dietary Modification Dietary Habits Behavioral: Non-personalised diet advice delivered via the eNutri app (control) Behavioral: Personalised diet advice delivered via the eNutri app (intervention) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : August 5, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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).




Primary Outcome Measures :
  1. eNutri diet quality score (DQS) [ Time Frame: Baseline & week 12 ]
    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.


Secondary Outcome Measures :
  1. Body mass index (BMI) [ Time Frame: Baseline & week 12 ]
    Self reported measurements of weight and height will be used to determine BMI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897972


Locations
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United Kingdom
Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences, University of Reading
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Julie Lovegrove, Professor Hugh Sinclair Unit of Human Nutrition

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Responsible Party: Julie Lovegrove, Director of the Hugh Sinclair Unit of Human Nutrition, University of Reading
ClinicalTrials.gov Identifier: NCT03897972    
Other Study ID Numbers: 08/19
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Lovegrove, University of Reading:
Personalised nutrition