Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention for two weeks | Experimental | Receipt 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 | Receipt 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-a-day fruit and vegetable mobile phone application | Behavioral | 5-a-day fruit and vegetable mobile phone application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment) | Self-report, questionnaire assessment | Intervention end |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31746766 | Derived | 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. |
Not provided
Not provided
Data will be available from the PI on request
Not provided
Following publication of findings in a peer-reviewed journal article.
Reasonable request of the PI.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention for Two Weeks | Receipt of the mobile phone application for two weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
| FG001 | Control for Two Weeks | Usual habitual activity - no receipt of mobile phone application for two weeks |
| FG002 | Intervention for Four Weeks | Receipt of the mobile phone application for four weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
| FG003 | Control for Four Weeks | Usual habitual activity - no receipt of mobile phone application for four weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention for Two Weeks | Receipt of the mobile phone application for two weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
| BG001 | Control for Two Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment) | Self-report, questionnaire assessment | Intention-to-Treat | Posted | Mean | Standard Deviation | FV portions per day | Intervention end |
|
Study duration - 2 or 4 weeks, as defined at study entry.
Questions from researcher
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention for Two Weeks | Receipt of the mobile phone application for two weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
Not provided
Not provided
Assessment of FV attitudes was originally planned but were not measured in the actual study to reduce demand characteristics for participants considering the large number of existing measures related to FV. No data on FV attitudes were collected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Katherine Appleton | Bournemouth University | +441202965985 | k.appleton@bournemouth.ac.uk |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2019 | Apr 15, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| Intervention end |
| App Usage | Number of days on which users interacted with the app. | Intervention end |
Usual habitual activity - no receipt of mobile phone application for two weeks
| BG002 | Intervention for Four Weeks | Receipt of the mobile phone application for four weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
| BG003 | Control for Four Weeks | Usual habitual activity - no receipt of mobile phone application for four weeks |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| FV intake | Mean | Standard Deviation | FV portions per day |
|
| FV knowledge | 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 assesses four aspects of FV knowledge in relation to the UK 5-a-day recommendations. Scores are provided for the subscale for portion sizes, 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. | Mean | Standard Deviation | Scores on a scale |
|
| Intervention for Four Weeks |
Receipt of the mobile phone application for four weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application |
| OG003 | Control for Four Weeks | Usual habitual activity - no receipt of mobile phone application for four weeks |
|
|
| Secondary | 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. | Intention-to-Treat | Posted | Mean | Standard Deviation | scores on a scale | Intervention end |
|
|
|
| Secondary | App Usage | Number of days on which users interacted with the app. | Control participants did not receive the app, so no app data is available | Posted | Mean | Standard Deviation | days used | Intervention end |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Control for Two Weeks | Usual habitual activity - no receipt of mobile phone application for two weeks | 0 | 27 | 0 | 27 | 0 | 27 |
| EG002 | Intervention for Four Weeks | Receipt of the mobile phone application for four weeks 5-a-day fruit and vegetable mobile phone application: 5-a-day fruit and vegetable mobile phone application | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | Control for Four Weeks | Usual habitual activity - no receipt of mobile phone application for four weeks | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
| Male |
|