- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02779491
Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application
October 7, 2019 updated by: Bournemouth University
This is a randomized controlled trial to assess the impact of a novel fruit and vegetable mobile phone application on fruit and vegetable intakes, knowledge and attitudes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The 5-a-day fruit and vegetable (FV) message from the WHO recommends consumption of five 80g portions of different FV per day for health reasons.
Recent research suggests that the details of the message are poorly understood by the population as a whole, by low consumers of FV and by those in demographic groups of traditional low FV consumption, and that this poor knowledge impacts on implementation of the message to result in low FV intakes.
To aid implementation of the recommendations, investigators have developed a 5-a-day FV mobile phone application (app) prototype.
The basic prototype app will provide information on the 5-a-day message, allow users to input consumption, and provides consumers with accurate knowledge of their adherence to the recommendations.
This study will investigate the use and impact of the prototype app on FV intakes over a two or four week period.
For significant impacts on health, sustained user engagement and use will be required.
Up to 100 participants will be randomised to either receive or not receive the app, and will be asked to use the app for the following two or four weeks.
FV intake will be assessed at baseline, 2 weeks, 4 weeks.
Measures of app use will also be taken at these time points.
Measures of FV knowledge will also be measured at these time points.
Measures of FV attitudes were initially planned but not undertaken to reduce demand characteristics for participants.
The investigators anticipate that changes in intakes will be mediated by changes in knowledge and attitudes.
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- able to provide informed consent
- speaks English, owns an android mobile telephone
- able and willing to use phone and complete all measures
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention for two weeks
Receipt of the mobile phone application for two weeks
|
5-a-day fruit and vegetable mobile phone application
|
|
No Intervention: Control for two weeks
Usual habitual activity - no receipt of mobile phone application for two weeks
|
|
|
Experimental: Intervention for four weeks
Receipt of the mobile phone application for four weeks
|
5-a-day fruit and vegetable mobile phone application
|
|
No Intervention: Control for four weeks
Usual habitual activity - no receipt of mobile phone application for two weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment)
Time Frame: Intervention end
|
Self-report, questionnaire assessment
|
Intervention end
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fruit and Vegetable Knowledge (Questionnaire Assessment)
Time Frame: Intervention end
|
FV knowledge will be assessed by the FV knowledge questionnaire published in Appleton et al.
J Hum Nutr Diet, 2018;31:121-130.
The questionnaire assessed four aspects of FV knowledge in relation to the UK 5-a-day recommendations.
The portion sizes subscale is provided, where positive scores are given for correct responses, and negative scores for incorrect responses.
Min.
max scores are -27, 27.
Higher scores show greater knowledge.
|
Intervention end
|
|
App Usage
Time Frame: Intervention end
|
Number of days on which users interacted with the app.
|
Intervention end
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
April 13, 2016
First Submitted That Met QC Criteria
May 19, 2016
First Posted (Estimate)
May 20, 2016
Study Record Updates
Last Update Posted (Actual)
October 8, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC10186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data will be available from the PI on request
IPD Sharing Time Frame
Following publication of findings in a peer-reviewed journal article.
IPD Sharing Access Criteria
Reasonable request of the PI.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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