ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Poor dietary intake

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Intervention code [2]

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]

Urinary carotenoid levels

Timepoint [1]

2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement

Primary outcome [2]

Dietary intake measured using the Australian Eating Survey

Timepoint [2]

2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement

Primary outcome [3]

Australian Recommended Food Score (ARFS). A measure of diet quality.

Timepoint [3]

2 weeks and 3 months post intervention commencement
6 months (primary endpoint) post intervention commencement

Secondary outcome [1]

Fasting blood samples will assayed for total cholesterol

Timepoint [1]