Nutritional StatusNCT02779491
Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application
A study testing 5-a-day fruit and vegetable mobile phone application in people with Nutritional Status and Nutrition Assessment, run by Bournemouth University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Status, Nutrition Assessment
- What is being tested?
- 5-a-day fruit and vegetable mobile phone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to provide informed consent
- speaks English, owns an android mobile telephone
- able and willing to use phone and complete all measures
Who cannot join
- none
About this study
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.
Read the 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.
- Conditions
- Nutritional Status, Nutrition Assessment
- Being tested
- 5-a-day fruit and vegetable mobile phone application
- Keywords
- fruit and vegetables, food intake, knowledge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-a-day fruit and vegetable mobile phone applicationBehavioural
5-a-day fruit and vegetable mobile phone application
| Study group | Role | What they receive |
|---|---|---|
| Intervention for two weeks | Experimental | Receipt of the mobile phone application for two weeks Receives: Behavioral: 5-a-day fruit and vegetable mobile phone application |
| Control for two weeks | No intervention | Usual habitual activity - no receipt of mobile phone application for two weeks |
| Intervention for four weeks | Experimental | Receipt of the mobile phone application for four weeks Receives: Behavioral: 5-a-day fruit and vegetable mobile phone application |
| Control for four weeks | No intervention | Usual habitual activity - no receipt of mobile phone application for two weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment)
Self-report, questionnaire assessment
Measured: Intervention end
Secondary outcomes (2)
Fruit and Vegetable Knowledge (Questionnaire Assessment)
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.
Measured: Intervention end
App Usage
Number of days on which users interacted with the app.
Measured: Intervention end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Jun 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779491
- Sponsor's protocol ID
- REC10186
- Status last verified
- Oct 2019
- First submitted
- 13 Apr 2016
- Last updated
- 8 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available from the PI on request
Publications
Appleton KM, Passmore D, Burn I, Pidgeon H, Nation P, Boobyer C, Jiang N. An Interactive Mobile Phone App (SMART 5-A-DAY) for Increasing Knowledge of and Adherence to Fruit and Vegetable Recommendations: Development and Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Nov 20;7(11):e14380. doi: 10.2196/14380.
PubMed 31746766
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application
- ClinicalTrials.gov ID
- NCT02779491
- Acronym / sponsor ID
- REC10186
- Conditions
- Nutritional Status, Nutrition Assessment
- Keywords
- fruit and vegetables, food intake, knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 8 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention for two weeks | Experimental | Behavioral: 5-a-day fruit and vegetable mobile phone applicationReceipt of the mobile phone application for two weeks |
| Control for two weeks | No intervention | –Usual habitual activity - no receipt of mobile phone application for two weeks |
| Intervention for four weeks | Experimental | Behavioral: 5-a-day fruit and vegetable mobile phone applicationReceipt of the mobile phone application for four weeks |
| Control for four weeks | No intervention | –Usual habitual activity - no receipt of mobile phone application for two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to provide informed consent
- speaks English, owns an android mobile telephone
- able and willing to use phone and complete all measures
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-a-day fruit and vegetable mobile phone application5-a-day fruit and vegetable mobile phone application | Behavioural | Intervention for four weeks, Intervention for two weeks |
Primary outcome
Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment)
Time frame: Intervention end
Self-report, questionnaire assessment
2 secondary outcomes
Fruit and Vegetable Knowledge (Questionnaire Assessment)
Time frame: Intervention end
App Usage
Time frame: Intervention end
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31746766Appleton KM, Passmore D, Burn I, Pidgeon H, Nation P, Boobyer C, Jiang N. An Interactive Mobile Phone App (SMART 5-A-DAY) for Increasing Knowledge of and Adherence to Fruit and Vegetable Recommendations: Development and Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Nov 20;7(11):e14380. doi: 10.2196/14380.
- Individual participant dataSharing planned: Yes. Data will be available from the PI on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 5-a-day fruit and vegetable mobile phone application in people with Nutritional Status and Nutrition Assessment, run by Bournemouth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment) (time frame: Intervention end). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02779491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.