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Trial registered on ANZCTR


Registration number
ACTRN12615000183583
Ethics application status
Approved
Date submitted
12/02/2015
Date registered
25/02/2015
Date last updated
19/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of fruit and vegetable consumption on psychological well-being: An ecological momentary intervention
Scientific title
The effect of a fruit and vegetable intervention versus an ecological momentary intervention versus no treatment on psychological well-being in low consuming young adults
Secondary ID [1] 286131 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low fruit and vegetable consumption 294165 0
Depression 294166 0
Anxiety 294167 0
Mood 294168 0
Condition category
Condition code
Diet and Nutrition 294494 294494 0 0
Other diet and nutrition disorders
Mental Health 294495 294495 0 0
Depression
Mental Health 294496 294496 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised into one of three conditions which are outlined below:

Arm 1: Fruit and Vegetable (FV) intervention group. Participants assigned to this condition will be given three additional servings of fruit and vegetables to consume daily for two weeks. The fruits and vegetables provided will vary depending on what is seasonal, commonly available and what will remain freshest for longest (e.g., carrots, kiwifruit, apples).

Arm 2: Ecological Momentary Intervention (EMI). Participants assigned to this group will be given a ‘challenge’ to increase their FV consumption, which will be aided by daily text-messages for two weeks. These messages will provide information, prompts, and suggestions for ways to improve their FV consumption in real-time.

Arm 3: Control group. Participants assigned to this group are encouraged to maintain their usual routine; however, will be asked to consume one piece of sugar free gum each day (to ensure that all participants are required to engage in the study each day).

Monitoring adherence: while the proposed study is heavily reliant on self report, adherence will be promoted by stressing the importance of honest and accurate reporting over reporting 'socially desirable' behaviour. Furthermore, the blood analysis for vitamins and carotenoids may provide some information about the current state of healthy eating. Participants will be informed that the inclusion of blood samples will allow insight into their general health, including healthy vs. unhealthy consumption. This provides a means of promoting accurate FV reporting based on social psychological principles (which show greater honesty in reporting when their reports can be checked against an objective marker).
Intervention code [1] 291231 0
Lifestyle
Comparator / control treatment
No-intervention control
Control group
Active

Outcomes
Primary outcome [1] 294271 0
Positive and negative mood as measured by survey measures (Circumplex Mood Checklist, Fordyce Happiness Measure)
Timepoint [1] 294271 0
At baseline, daily during intervention, and at 14 days (i.e., the conclusion of intervention)
Primary outcome [2] 294272 0
Depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D)
Timepoint [2] 294272 0
At baseline and at 14 days (i.e., the conclusion of intervention)
Primary outcome [3] 294273 0
Anxiety as measured by the anxiety sub-scale of the Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 294273 0
At baseline and at 14 days (i.e., the conclusion of intervention)
Secondary outcome [1] 312923 0
Psychological well-being as measured by the Flourishing Scale
Timepoint [1] 312923 0
At baseline and at 14 days (i.e., the conclusion of intervention)
Secondary outcome [2] 312924 0
Vitality as measured by the Health and Vitality scale of the Short-form 36
Timepoint [2] 312924 0
At baseline, daily during the intervention, and at 14 days (i.e., the conclusion of intervention)
Secondary outcome [3] 312925 0
Micronutrient status of vitamin c as measured in blood
Timepoint [3] 312925 0
At baseline and at 14 days (i.e., the conclusion of intervention)
Secondary outcome [4] 312926 0
Micronutrient status of serum carotenoids as measured in blood
Timepoint [4] 312926 0
At baseline and at 14 days (i.e., the conclusion of intervention)
Secondary outcome [5] 313075 0
Fruit and vegetable consumption assessed using a daily food questionnaire based on questions from the New Zealand Adult Nutrition Survey.
Timepoint [5] 313075 0
Assessed daily for 14 days during the intervention.

Eligibility
Key inclusion criteria
Inclusion criteria: must be in the young adult age range (18-25), pre-screened for being low fruit and vegetables consumers (i.e., no more than an average of two daily servings), and have an internet enabled mobile phone.
Minimum age
18 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those with a known fruit or vegetable allergy or taking antidepressant medication will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size of 150 participants (50 in each condition) will provide 93% power to detect a one serving difference in FV consumption between the experimental and control groups (at p< .05) and 85% power to determine a .3 standard deviation difference in mental health scores between groups (at p< .05).

ANCOVA analyses will test for group differences between both the intervention groups and the control group on: pre- and post-test changes in mental health, average daily differences in vitality and mood; average daily differences in FV consumption controlling for covariates including (but not limited to) gender, BMI, and exercise.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6654 0
New Zealand
State/province [1] 6654 0
Otago

Funding & Sponsors
Funding source category [1] 290729 0
University
Name [1] 290729 0
University of Otago Research Grant
Address [1] 290729 0
University of Otago
362 Leith Street
Dunedin. 9016

Country [1] 290729 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
362 Leith Street
Dunedin. 9016

Country
New Zealand
Secondary sponsor category [1] 289419 0
None
Name [1] 289419 0
Address [1] 289419 0
Country [1] 289419 0
Other collaborator category [1] 278346 0
Individual
Name [1] 278346 0
Dr Margreet Vissers
Address [1] 278346 0
Centre for Free Radical Research
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand

Country [1] 278346 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292366 0
University of Otago Human (Health) Ethics Committee
Ethics committee address [1] 292366 0
University of Otago
362 Leith Street
Dunedin. 9016
New Zealand
Ethics committee country [1] 292366 0
New Zealand
Date submitted for ethics approval [1] 292366 0
Approval date [1] 292366 0
29/01/2015
Ethics approval number [1] 292366 0
H15/010

Summary
Brief summary
The proposed study is a brief two week intervention (randomised control trial, RCT) to test the influence of fruit and vegetable consumption on short term changes in mental health in a healthy, young adult population with low fruit and vegetable consumption. A total of 150 participants aged 18-25 will be randomised into three groups: an increased fruit and vegetable group (to be given an additional 3 servings of fruit and vegetables per day for two weeks); a reminder group (to receive nutritional information and mobile text message reminders to eat more fruit and vegetables for two weeks); and a no-intervention control group. A range of mental health measures (depression, anxiety, and mood) will be measured before, during, and after the intervention, and compared between groups. All participants will complete daily assessments of mood and food consumption using their mobile phones. Additionally, a blood sample will be taken before and after the intervention for analysis of biomarkers of fruit and vegetable consumption; specifically, vitamin C and serum carotenoids.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54758 0
Dr Tamlin Conner
Address 54758 0
Department of Psychology
University of Otago
William James Building
Level 1
275 Leith Walk
Dunedin 9016
Country 54758 0
New Zealand
Phone 54758 0
+64 (03) 479-7624
Fax 54758 0
Email 54758 0
tconner@psy.otago.ac.nz
Contact person for public queries
Name 54759 0
Dr Tamlin Conner
Address 54759 0
Department of Psychology
University of Otago
William James Building
Level 1
275 Leith Walk
Dunedin 9016
Country 54759 0
New Zealand
Phone 54759 0
+64 (03) 479-7624
Fax 54759 0
Email 54759 0
tconner@psy.otago.ac.nz
Contact person for scientific queries
Name 54760 0
Dr Tamlin Conner
Address 54760 0
Department of Psychology
University of Otago
William James Building
Level 1
275 Leith Walk
Dunedin 9016
Country 54760 0
New Zealand
Phone 54760 0
+64 (03) 479-7624
Fax 54760 0
Email 54760 0
tconner@psy.otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary