Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000118202
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
29/01/2018
Date last updated
13/07/2021
Date data sharing statement initially provided
13/07/2021
Date results information initially provided
13/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating an online nutrition program for young adult university students: Eating Advice To Students (EATS)
Scientific title
Feasibility and preliminary efficacy of a brief online nutrition intervention for young adult university students
Secondary ID [1] 293865 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 306351 0
Condition category
Condition code
Public Health 305439 305439 0 0
Health promotion/education
Diet and Nutrition 305455 305455 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eating Advice To Students (EATS) is a brief or single use intervention. The goal of EATS is to facilitate improvement in overall diet quality, including targeting four specific eating behaviours: consumption of fruit, vegetables, discretionary foods and breakfast. The intervention involves password protected access to the EATS website (www.eatingadvicetostudents.com) on a single occasion. The website includes four components; 1) a brief screening quiz providing personalised feedback on eating behaviours and barriers to healthy eating, 2) provision of information, tips and strategies for each target behaviour, and two guided exercises to facilitate behaviour change; 3) goal-setting and 4) creating strategies. The intervention has been developed based on the PRECEDE-PROCEED planning model, and incorporates formative research, including an online survey of 4,581 university students, and a systematic review of brief nutrition interventions. The intervention components and content are mapped to behaviour change techniques, as identified to be effective in formative research.
Intervention code [1] 300149 0
Behaviour
Intervention code [2] 300150 0
Lifestyle
Intervention code [3] 300151 0
Prevention
Comparator / control treatment
Attention control: control group participants will complete Thrive (https://www.thrivehealth.org.au/university-of-newcastle/survey.php), a brief online intervention designed for university students with a focus on alcohol intake. Thrive provides feedback on current alcohol intake and behaviour in relation to risk, and further resources for support. Control group participants will also receive access to the EATS intervention after completing the 3 month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 304570 0
Program acceptability will be evaluated using a process evaluation survey (intervention group only) designed by the researchers for this study.
Timepoint [1] 304570 0
Post intervention (within 1 month)
Primary outcome [2] 304571 0
Intervention participants usage of the intervention (e.g. website visit duration, number of links accessed).
Timepoint [2] 304571 0
Throughout intervention
Primary outcome [3] 304572 0
Dietary intake (diet quality) will be assessed using a validated Food Frequency Questionnaire (Australian Eating Survey). As this is a feasibility study this outcome is to determine preliminary efficacy.
Timepoint [3] 304572 0
Change from baseline to follow-up (3 months)
Secondary outcome [1] 342431 0
Interventions ability to recruit and retain the target group. The numbers enquiring, screened for eligibility, consenting, randomised, completing the intervention and completing follow-up will be recorded (Primary outcome)
Timepoint [1] 342431 0
Throughout intervention
Secondary outcome [2] 342432 0
Dietary intake (fruit, vegetables, discretionary foods and breakfast consumption) will be assessed using a validated Food Frequency Questionnaire (Australian Eating Survey). As this is a feasibility study this outcome is to determine preliminary efficacy.
Timepoint [2] 342432 0
Change from baseline to follow-up (3 months)
Secondary outcome [3] 342433 0
Alcohol intake will be assessed using short questions from the NSW Adult Population Health Survey.
Timepoint [3] 342433 0
Change from baseline to follow-up (3 months)
Secondary outcome [4] 342434 0
Self-efficacy for performing target eating behaviours will be assessed using questions developed by the researchers for this study, derived from the Project EAT II Survey for Young Adults study.
Timepoint [4] 342434 0
Change from baseline to follow-up (3 months)
Secondary outcome [5] 342435 0
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short form
Timepoint [5] 342435 0
Change from baseline to follow-up (3 months)
Secondary outcome [6] 342436 0
Well-being will be assessed using the World Health Organization-Five Well-being Index (WHO-5)
Timepoint [6] 342436 0
Change from baseline to follow-up (3 months)

Eligibility
Key inclusion criteria
Age 17-35 years
Currently enrolled as a student at the University of Newcastle, Australia
Minimum age
17 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have a medical condition requiring prescribed dietary advice
Currently enrolled as a student at the University of Newcastle, Australia, Singapore campus or an external/distance student located outside of Australia

Study design
Purpose of the study
Prevention
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)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2018
Actual
20/02/2018
Date of last participant enrolment
Anticipated
Actual
29/03/2018
Date of last data collection
Anticipated
30/06/2018
Actual
30/06/2018
Sample size
Target
126
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298484 0
University
Name [1] 298484 0
The University of Newcastle
Country [1] 298484 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan, NSW, Australia, 2308
Country
Australia
Secondary sponsor category [1] 297624 0
None
Name [1] 297624 0
Address [1] 297624 0
Country [1] 297624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299471 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 299471 0
University Drive, Callaghan, NSW, Australia, 2308
Ethics committee country [1] 299471 0
Australia
Date submitted for ethics approval [1] 299471 0
30/11/2017
Approval date [1] 299471 0
15/02/2018
Ethics approval number [1] 299471 0
H-2017-0404

Summary
Brief summary
The aim of this research is to evaluate the feasibility (e.g. acceptability, usage and ability to recruit and retain) of a brief (single use) online nutrition intervention for young adult (17-35 years) university students, and to estimate its preliminary efficacy in changing eating behaviours compared with control. Participants will be randomly allocated to the intervention (EATS: Eating Advice To Students) or attention control (Thrive online alcohol intervention) group. Participants in both groups will be asked to complete online questionnaires prior to completing the intervention or control program (baseline) and 3 months later (follow-up). Participants in the intervention group will also be asked to complete an additional online survey to assess the acceptability of EATS. Participant’s usage of the EATS website will also be tracked.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80518 0
Dr Melinda Hutchesson
Address 80518 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 80518 0
Australia
Phone 80518 0
+61 2 49215405
Fax 80518 0
Email 80518 0
Melinda.hutchesson@newcastle.edu.au
Contact person for public queries
Name 80519 0
Dr Melinda Hutchesson
Address 80519 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 80519 0
Australia
Phone 80519 0
+61 2 49215405
Fax 80519 0
Email 80519 0
Melinda.hutchesson@newcastle.edu.au
Contact person for scientific queries
Name 80520 0
Dr Melinda Hutchesson
Address 80520 0
School of Health Sciences, Hunter Building (HA12), University Drive, The University of Newcastle, Callaghan, NSW 2308
Country 80520 0
Australia
Phone 80520 0
+61 2 49215405
Fax 80520 0
Email 80520 0
Melinda.hutchesson@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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Whatnall MC, Patterson AJ, Chiu S, Oldmeadow C, Hu... [More Details]
Study results articleYes Whatnall MC, Patterson AJ, Hutchesson MJ. A Brief ... [More Details]

Documents added automatically
No additional documents have been identified.