RecruitingACTRN12619001415190

Trialing a fruit and vegetable intervention to promote a healthy weight and reduce disease risk

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


Sponsor

The University of Newcastle

Enrollment

120 participants

Start Date

Sep 9, 2019

Study Type

Interventional

Conditions

Summary

Only 5% of Australian adults meet the recommended intake of fruit & vegetables. Energy from discretionary foods contributes to one third of total energy intake. Together these dietary patterns contribute to the prevalence of overweight and obesity in Australia. This 6 month study will trial two dietary patterns aimed to increase fruit and vegetable consumption and subsequently decrease consumption of discretionary foods. Participants will be randomised to one of two fruit and vegetable eating patterns. All participants will receive 2 weeks worth of fruit and vegetables. The type of fruit and vegetables they receive will depend on the group they have been radomised into. Participants will also be supported via personalised dietary consultations which will be delivered intensively in the first three months and then less intensively (maintenance phase) in the second three months. Aim: Evaluate the effect of two dietary patterns on diet quality, body composition, skin & urinary carotenoids, blood lipids and glucose. 2. To validate the Australian Eating Survey (AES).


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Most Australians do not eat nearly enough fruit and vegetables, and this contributes to poor health outcomes including overweight, obesity, and chronic disease. This 6-month study is testing two different approaches to encouraging people to eat more fruit and vegetables and fewer processed, high-calorie foods. Participants will be randomly assigned to one of two fruit and vegetable eating patterns and receive fortnightly supply of produce as part of the intervention. Alongside the produce, participants will receive personalised dietary counselling — with more intensive sessions in the first three months and a maintenance phase in the second three months. The study will measure diet quality, body composition, blood sugar and lipid levels, and skin and urine markers of fruit and vegetable intake. This is also designed to validate a dietary survey tool called the Australian Eating Survey. You may be eligible if you are 18 or older, have been weight-stable for the past two months, and have access to the internet. People who are pregnant, have a pacemaker or similar implanted device, take medications affecting weight or metabolism, have significant food allergies, or have serious medical conditions such as insulin-dependent diabetes, heart failure, or kidney disease are not eligible. This study is ideal for someone who wants practical, supported help in eating more healthily.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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, tomat

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.


Locations(1)

NSW, Australia

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ACTRN12619001415190