Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application
Phase: NA
Conditions: Nutritional Status, Nutrition Assessment
Sponsor: Bournemouth University

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STUDY ID: NCT02779491. 
 
EVALUATION OF A 5-A-DAY FRUIT AND VEGETABLE MOBILE PHONE APPLICATION 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
DOCUMENT DATE: 15.04.19 
 
 
 

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METHODS 
Evaluation of the app was undertaken using a randomized controlled pilot trial, where volunteers 
were randomized to receive or not receive the app for either two weeks or four weeks and FV 
knowledge, FV intake and FV behaviour were assessed and compared at baseline and at study end.  
 
Volunteers 
Volunteers to test the app were recruited from the staff and students of Bournemouth University, 
UK, from Nov., 2015 to March, 2017. We aimed to recruit 100 volunteers - 50 to test the app and 50 
to act as controls. No earlier research was available to allow power calculations, thus 50 volunteers 
were considered sufficient to gain feedback and assess potential impacts of the app, while remaining 
manageable should few impacts be found. Adult volunteers (aged 18 years and over) were required 
to own an Android smart phone, as the app was only developed for Android platforms, but there 
were no other inclusion / exclusion criteria to maximise the generalisability of the study. Volunteers 
were recruited for a study to ‘test a novel mobile phone app for encouraging healthy behaviours’. 
Volunteers were thus aware at the study start, that they may or may not receive an app to test, but 
they were informed that that the app may target one of a number of health behaviours, such as 
exercising, stress reduction or healthy eating.  
 
Intervention / Control  
Volunteers were randomized to receive the app (intervention) or not receive the app (control). 
Randomization was undertaken on study entry by drawing lots, and recruitment stopped once 50 
individuals had been randomized to test the app. All volunteers who received the app were asked to 
download the app onto their phones, to register with the app to set-up a user profile, and to use the 
app as often as they wished for either a two week or a four week period. The app was tested for two 
weeks from Nov. 2015 - March 2016 and from Nov. 2016 - March 2017, and for four weeks from 
June 2016 - August 2016.  
 
Outcomes  
Awareness of the 5-a-day FV recommendations, FV knowledge and FV intake were assessed as 
outcomes, at baseline, at a mid point, and at study end. Awareness of the recommendations, FV 
knowledge and self-reported FV intakes were assessed using a questionnaire previously developed 
by ourselves [1]. The questionnaire consisted of two questions on awareness of the 5-a-day 
message, four questions on knowledge of the details of the message (which foods are included, 
portion sizes, the need for variety, reasons for consumption), and two questions on FV intake, as 

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detailed below. FV behaviour was also assessed as part of the trial using a behavioural measure.  
Two questions on demographic and lifestyle characteristics that have previously been associated 
with FV consumption and dietary knowledge [1-9] were also assessed as potential confounders. All 
volunteers (intervention and control) completed all outcome assessments in the same manner.  
 
Awareness of the recommendations: Awareness of the recommendations were assessed using two 
open-response questions: ‘Are you aware of the 5-a-day FV message?’ and ‘What do you think it 
means?’ 
 
FV knowledge: FV knowledge was assessed using four structured closed-response questions on: 1) 
the FV that are included in the message; 2) the portion sizes that are required for the message; 3) 
the variety that is required for the message; and 4) the reasons for FV consumption. These questions 
include 1) a number of foods; 2) a number of different portions of FV; 3) a number of combinations 
of FV to be consumed in a day; and 4) a number of different health conditions, respectively, and 
respondents were asked to report 1) inclusion in the recommendations or not; 2) contribution to the 
recommendations based on portion sizes; 3) number of FV portions consumed in the day; and 4)  
impact of FV on each health condition, respectively. For all questions, a correct response, based on 
current recommendations from the UK Government [10], was scored +1, an incorrect response was 
scored -1, and ‘don’t know / not sure’ was scored 0. Missing values were also completed with 0, 
where found.   
 
Self-report FV intake: FV intake was assessed using one open-response structured question 
requesting household amounts (e.g. tablespoons) of all FV consumed at various time points (before 
breakfast, breakfast, morning, lunch, afternoon, evening meal, evening) on a typical weekday and on 
a typical weekend day, and one open-response question asking for estimated number of portions of 
FV consumed per day. The structured question was used to calculate portions of FV consumed per 
day (calculated FV), while the single question was used to provide an estimated measure (estimated 
FV).  
 
FV Behaviour: FV intake was also assessed using a behavioural measure. Volunteers were offered a 
drink while completing all questionnaires, and given the choice of a tea, coffee, water or fruit 
smoothie. Selections of the fruit smoothie were considered an FV choice, while all other drinks were 
considered a non-FV choice. No drink was also a permitted option.  
 

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Demographic and Lifestyle Characteristics: Demographic and lifestyle characteristics also assessed 
were: gender, age, marital status, living status, number of years of education, smoking habits, 
alcoholic drinking habits, dietary supplement taking habits, and height and weight (to calculate BMI).  
 
App Feedback 
Number of uses were requested from volunteers who received the app, and downloaded from the 
app itself. Volunteers who received the app were also asked to feedback on their experiences and 
offer suggestions for the app. 
 
Psychological Stress 
To encourage a perception that healthy eating was not necessarily the focus of the study, the 
Psychological Stress Measure [11] was also provided to participants. This questionnaire consists of 
49 statements relating to somatic, cognitive-affective and behavioural outcomes of stress. 
Respondents rate the extent to which they have experienced these outcomes in the last week on an 
8-point scale ranging from 1 (not at all) to 8 (extremely). These data were not analysed. 
 
Procedure  
Volunteers undertook all outcome assessments at the Eating Behaviours Laboratory, Bournemouth 
University, UK. On each assessment occasion, volunteers completed all questionnaires, were offered 
a drink, and had every opportunity to ask questions. One researcher randomized all volunteers and 
dealt with all queries (IB, HP, PN, CB), while another researcher oversaw all outcome assessments, 
thus this researcher was blind to treatment (IB, HP, PN, CB).  
 
The study was given ethical approval by the Research Ethics Committee of Bournemouth University, 
prior to commencement, and was registered as a clinical trial on www.clinicaltrials.gov (ID 
NCT02779491). Methods were undertaken as detailed in the trial registration with the exception 
that a behavioural measure of FV intake was added to the study prior to commencement, and a 
measure of FV attitudes was not undertaken. Attitudes towards FV were not measured to reduce 
demand characteristics given the extensive FV knowledge questionnaire. All participants provided 
written informed prior to starting the study.  
 
Analysis: Data were analysed on an Intention-to-Treat basis, where missing data were completed 
using Last Observation Carried Forward. Demographic and lifestyle variables and all measures at 
baseline were first described and compared using t-tests, based on study duration and app / control 

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grouping. Several important differences were found between those studied for two weeks and those 
studied for four weeks, thus study duration was included in all subsequent analyses. All FV 
knowledge and intake outcome assessed by questionnaire were analysed using 2 (study duration) x 
2 (app / control) x 2 (baseline / study end) mixed ANOVA. Our behavioural measure of FV intake – 
choice of fruit drink or non-fruit drink was analysed using Chi-squared tests. All data are reported as 
means and standard deviations. Significance was set at p<0.05.  
 
 
 

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REFERENCES 
1. Appleton KM, Krumplevska K, Smith E, Rooney C, McKinley MC, Woodside JV. Low fruit and 
vegetable consumption is associated with low knowledge of the details of the 5-a-day fruit and 
vegetable message in the UK: Findings from two cross-sectional questionnaire studies. J Hum Nutr 
Diet, 2018;31:121-130. 
2. Appleton KM, McGill R, Woodside JV. Fruit and vegetable consumption in older people in 
Northern Ireland: levels and patterns. Brit J Nutr. 2009;102:949-953.  
3. Appleton KM, McGill R, Neville C, Woodside JV. Barriers to increasing fruit and vegetable intakes 
in the older population of Northern Ireland: Low levels of liking and low awareness of current 
recommendations. Pub Health Nutr. 2010;13:514-521.  
4. Ashfield-Watt PAL. Fruit and vegetables, 5+ a day: are we getting the message across? Asia Pac J 
Clin Nutr. 2006;15:245-52. 
5. Pollard CM, Miller MR, Daly AM, et al. Increasing fruit and vegetable consumption: success of the 
Western Australian Go for 2&5 campaign. Pub Health Nutr. 2007;11:314-320. 
6. Erinosho TO, Moser RP, Oh AY, Nebeling LC, Yaroch AL. Awareness of the Fruits and Veggies – 
More Matters campaign, knowledge of the fruit and vegetable recommendation, and fruit and 
vegetable intake of adults in the 2007 Food Attitudes and Behaviors (FAB) Survey. Appetite 
2012;59:155-160. 
7. Pollard CM, Daly AM, Binns CW. Consumer perceptions of fruit and vegetables serving sizes. Pub 
Health Nutr. 2008;12:637-43. 
8. Herbert G, Butler L, Kennedy O, Lobb A. Young UK adults and the 5 A DAY campaign: Perceived 
benefits and barriers to eating more fruits and vegetables. Int J Cons Studies. 2010;34:657-64. 
9. Dixon H, Mullins R, Wakefield M, Hill D. Encouraging the consumption of FVs by older Australians: 
An experiential study. J Nutr Educ Behav. 2004;36:245-249. 
10. Bates B, Lennox A, Swan G. National Diet Nutrition Survey: Headline results for year 1 of the 
rolling programme (2008/2009), London: Food Standards Agency, 2009. 
11. Lemyre L, Tessier R. Measurement of psychological stress: To feel stressed. Can J Behav Sci. 
1998;20:302-321.