Trial Outcomes & Findings for Evaluation of a 5-a-day Fruit and Vegetable Mobile Phone Application (NCT NCT02779491)
NCT ID: NCT02779491
Last Updated: 2019-10-08
Results Overview
Self-report, questionnaire assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
Intervention end
Results posted on
2019-10-08
Participant Flow
Participant milestones
| Measure |
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
|
Control for Two Weeks
Usual habitual activity - no receipt of mobile phone application for two weeks
|
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
|
Control for Four Weeks
Usual habitual activity - no receipt of mobile phone application for four weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
27
|
18
|
17
|
|
Overall Study
COMPLETED
|
32
|
26
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention for Two Weeks
n=32 Participants
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
|
Control for Two Weeks
n=27 Participants
Usual habitual activity - no receipt of mobile phone application for two weeks
|
Intervention for Four Weeks
n=18 Participants
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
|
Control for Four Weeks
n=17 Participants
Usual habitual activity - no receipt of mobile phone application for four weeks
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
22.3 years
STANDARD_DEVIATION 7.7 • n=32 Participants
|
21.4 years
STANDARD_DEVIATION 5.3 • n=27 Participants
|
25.9 years
STANDARD_DEVIATION 7.9 • n=18 Participants
|
25.9 years
STANDARD_DEVIATION 7.9 • n=17 Participants
|
23.4 years
STANDARD_DEVIATION 7.5 • n=94 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=32 Participants
|
17 Participants
n=27 Participants
|
12 Participants
n=18 Participants
|
12 Participants
n=17 Participants
|
63 Participants
n=94 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=32 Participants
|
10 Participants
n=27 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
31 Participants
n=94 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
32 Participants
n=32 Participants
|
27 Participants
n=27 Participants
|
18 Participants
n=18 Participants
|
17 Participants
n=17 Participants
|
94 Participants
n=94 Participants
|
|
FV intake
|
3.9 FV portions per day
STANDARD_DEVIATION 1.5 • n=32 Participants
|
3.7 FV portions per day
STANDARD_DEVIATION 2.3 • n=27 Participants
|
4.4 FV portions per day
STANDARD_DEVIATION 1.2 • n=18 Participants
|
3.7 FV portions per day
STANDARD_DEVIATION 1.3 • n=17 Participants
|
3.9 FV portions per day
STANDARD_DEVIATION 1.9 • n=94 Participants
|
|
FV knowledge
|
-5.5 Scores on a scale
STANDARD_DEVIATION 6.5 • n=32 Participants
|
-7.6 Scores on a scale
STANDARD_DEVIATION 6.3 • n=27 Participants
|
-8.2 Scores on a scale
STANDARD_DEVIATION 5.1 • n=18 Participants
|
-8.1 Scores on a scale
STANDARD_DEVIATION 4.8 • n=17 Participants
|
-7.1 Scores on a scale
STANDARD_DEVIATION 5.8 • n=94 Participants
|
PRIMARY outcome
Timeframe: Intervention endPopulation: Intention-to-Treat
Self-report, questionnaire assessment
Outcome measures
| Measure |
Intervention for Two Weeks
n=32 Participants
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
|
Control for Two Weeks
n=27 Participants
Usual habitual activity - no receipt of mobile phone application for two weeks
|
Intervention for Four Weeks
n=18 Participants
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
|
Control for Four Weeks
n=17 Participants
Usual habitual activity - no receipt of mobile phone application for four weeks
|
|---|---|---|---|---|
|
Fruit and Vegetable Intakes (Self-report, Questionnaire Assessment)
|
3.8 FV portions per day
Standard Deviation 1.7
|
2.6 FV portions per day
Standard Deviation 2.0
|
5.2 FV portions per day
Standard Deviation 1.6
|
4.0 FV portions per day
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Intervention endPopulation: Intention-to-Treat
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.
Outcome measures
| Measure |
Intervention for Two Weeks
n=32 Participants
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
|
Control for Two Weeks
n=27 Participants
Usual habitual activity - no receipt of mobile phone application for two weeks
|
Intervention for Four Weeks
n=18 Participants
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
|
Control for Four Weeks
n=17 Participants
Usual habitual activity - no receipt of mobile phone application for four weeks
|
|---|---|---|---|---|
|
Fruit and Vegetable Knowledge (Questionnaire Assessment)
|
-2.5 scores on a scale
Standard Deviation 7.7
|
-5.5 scores on a scale
Standard Deviation 8.7
|
-7.7 scores on a scale
Standard Deviation 9.5
|
-5.3 scores on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Intervention endPopulation: Control participants did not receive the app, so no app data is available
Number of days on which users interacted with the app.
Outcome measures
| Measure |
Intervention for Two Weeks
n=32 Participants
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
|
Control for Two Weeks
Usual habitual activity - no receipt of mobile phone application for two weeks
|
Intervention for Four Weeks
n=18 Participants
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
|
Control for Four Weeks
Usual habitual activity - no receipt of mobile phone application for four weeks
|
|---|---|---|---|---|
|
App Usage
|
11.4 days used
Standard Deviation 7.2
|
—
|
13.7 days used
Standard Deviation 9.2
|
—
|
Adverse Events
Intervention for Two Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control for Two Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention for Four Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control for Four Weeks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place