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Trial registered on ANZCTR


Registration number
ACTRN12619001415190
Ethics application status
Approved
Date submitted
24/08/2019
Date registered
15/10/2019
Date last updated
15/10/2019
Date data sharing statement initially provided
15/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trialing a fruit and vegetable intervention to promote a healthy weight and reduce disease risk
Scientific title
A randomised controlled trial in healthy adults evaluating the impact of high and low carotenoid dietary patterns on diet quality, weight status and metabolic markers and validate the Australian Eating Survey
Secondary ID [1] 298964 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor dietary intake 313953 0
Condition category
Condition code
Diet and Nutrition 312360 312360 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High carotenoid intake/high variety fruit & vegetable intake (ß-carotene content >50µg/100g). The fruits and vegetables included consist of carrots, sweet potato, pumpkin, red capsicum, lettuce, tomato, broccoli, cucumber, zucchini, frozen peas & corn, canned tomatoes, frozen mixed berries, bananas and oranges. There will be 28X 150g serves of fruit and 70X 75g serves of vegetables

- In the first 2 weeks participants will be given 2 weeks worth of variety fruit and vegetables high in carotenoids will be determined by carotenoid content. To reduce bias participants will not be given this specific information.
- In addition (during first 3 months): intervention phase = personalized dietary consultations (2 compulsory sessions and 1 optional consult) and emails (n=2)
- In the following 3 months: maintenance phase = which includes personalized dietary consultations (2 optional consults) and emails (n=2). During the phase the intensity of the dietary consultations will reduce.

The intervention components will be delivered by an Accredited Practicing Dietitian. Participants will be asked to used an image-based food record to self-monitor and self-report their intake, for 3 days in the week following the data collection sessions (2 weeks, 3 months and 6 months post baseline)

The dietary consultations will follow a predetermined plan, based on the Behaviour Change Wheel. Briefly, the dietitian will review the Australian Eating Survey Report and responses to a Personalised Nutrition Questionnaire (PNQ) with participants. Personalised goals will be set and strategies to reach these goals will be discussed. These strategies will come from the Personalised Nutrition Toolbox which corresponds to the PNQ. A summary of the session and resources will be emailed to participants after the session. The optional sessions will review goals and strategies to determine if progress is being made or if goals/strategies need to be adjusted. Participants will be encouraged to book in for these sessions but it will be at their discretion if they want to attend all the optional follow up sessions.

The emails will provide participants with encouragement by reminding them they have reached week 4, 8, 14 and 18 respectively. It will provide reminders about the aims of the study and dietary information on how they can maintain the fruit and vegetable eating patterns e.g. resource sheets and website links

The resources and links will be ones that are already available and are sourced from government departments, the Dietitians Association of Australia, Nutrition Education Materials Online, Australian Healthy Food Guide and Practice Based Evidence in Nutrition.
Intervention code [1] 315235 0
Behaviour
Intervention code [2] 315463 0
Treatment: Other
Comparator / control treatment
Low carotenoid/low variety fruit & vegetable intake (ß-carotene content <50µg/100g). The fruits and vegetables included consist of: mushroom, cauliflower, onion, cabbage, potatoes, lentils, apples & pears.
- In the first 2 weeks participants will be given 2 weeks worth of low variety fruit and vegetables low in cartenoids. To reduce bias participants will not be given this specific information.
- In addition (during first 3 months): intervention phase = personalized dietary consultations (2 compulsory sessions and 1 optional consult) and emails (n=2)
- In the following 3 months: maintenance phase = which includes personalized dietary consultations (2 optional consults) and emails (n=2)
Control group
Active

Outcomes
Primary outcome [1] 320987 0
Urinary carotenoid levels
Timepoint [1] 320987 0
2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement
Primary outcome [2] 321028 0
Dietary intake measured using the Australian Eating Survey
Timepoint [2] 321028 0
2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement
Primary outcome [3] 321264 0
Australian Recommended Food Score (ARFS). A measure of diet quality.
Timepoint [3] 321264 0
2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement
Secondary outcome [1] 373604 0
Fasting blood samples will assayed for total cholesterol
Timepoint [1] 373604 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [2] 373740 0
Fasting blood samples will assayed for fasting plasma glucose
Timepoint [2] 373740 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [3] 373741 0
Skin carotenoids measured using spectrophotometer
Timepoint [3] 373741 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [4] 373742 0
Blood pressure measured using Cardioscope II
Timepoint [4] 373742 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [5] 373743 0
Percentage body fat will measured using bioelectrical impedance
Timepoint [5] 373743 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [6] 373744 0
Energy expenditure (resting metabolic rate) will measured using the FitMate indirect calorimeter
Timepoint [6] 373744 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [7] 373745 0
Quality of life will be measured using the Quality of Life (SF-12)
Timepoint [7] 373745 0
2 weeks, 3 months & 6 months post intervention commencement
Secondary outcome [8] 374482 0
Weight (kg) measured on a digital scale
Timepoint [8] 374482 0
2 weeks, 3 months and 6 months post intervention commencement
Secondary outcome [9] 374878 0
Fasting blood samples will assayed for triglycerides
Timepoint [9] 374878 0
2 weeks, 3 months and 6 months post intervention commencement
Secondary outcome [10] 374879 0
Fasting blood samples will assayed for LDL
Timepoint [10] 374879 0
2 weeks, 3 months and 6 months post intervention commencement
Secondary outcome [11] 374880 0
Fasting blood samples will assayed for HDL
Timepoint [11] 374880 0
2 weeks, 3 months and 6 months post intervention commencement
Secondary outcome [12] 374881 0
Fasting blood samples will assayed for fasting insulin
Timepoint [12] 374881 0
2 weeks, 3 months and 6 months post intervention commencement
Secondary outcome [13] 374882 0
Arterial stiffness measured using Cardioscope II
Timepoint [13] 374882 0
2 weeks, 3 months and 6 months post intervention commencement

Eligibility
Key inclusion criteria
Aged 18 years or above; are weight stable (±4kg in the past 2 months) and have access to broadband internet access.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Are currently pregnant, breastfeeding or trying to conceive
• Have a pacemaker, cochlear implant or similar electronic device
• Taking medications and/or supplements that affect metabolic rate, weight or fluid balance
• Have special dietary requirements or dietary restrictions due to food allergies and/or intolerance
• Have one of the following medical conditions: diabetes controlled by insulin, heart failure, chronic respiratory disease, pancreatitis, renal disease, liver disease, claustrophobia or similar conditions

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation, stratified by gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/09/2019
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
120
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303507 0
University
Name [1] 303507 0
The University of Newcastle
Country [1] 303507 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive,
Callaghan
2308 NSW
Country
Australia
Secondary sponsor category [1] 303603 0
None
Name [1] 303603 0
Address [1] 303603 0
Country [1] 303603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304031 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 304031 0
Ethics committee country [1] 304031 0
Australia
Date submitted for ethics approval [1] 304031 0
Approval date [1] 304031 0
16/08/2019
Ethics approval number [1] 304031 0
H-2019-0147

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95602 0
Prof Clare Collins
Address 95602 0
ATC310
ATC building
University of Newcastle
University Drive
Callaghan
2308 NSW
Country 95602 0
Australia
Phone 95602 0
+61 249215646
Fax 95602 0
Email 95602 0
clare.collins@newcastle.edu.au
Contact person for public queries
Name 95603 0
Katherine Brain
Address 95603 0
School Health Sciences
University of Newcastle
University Drive
Callaghan
2308 NSW
Country 95603 0
Australia
Phone 95603 0
+61 249217254
Fax 95603 0
Email 95603 0
katherine.brain@newcastle.edu.au
Contact person for scientific queries
Name 95604 0
Katherine Brain
Address 95604 0
School Health Sciences
University of Newcastle
University Drive
Callaghan
2308 NSW
Country 95604 0
Australia
Phone 95604 0
+61 249217254
Fax 95604 0
Email 95604 0
katherine.brain@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.