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

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.

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

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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