Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000771550p
Ethics application status
Submitted, not yet approved
Date submitted
12/03/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of an online fibre education intervention on fibre consumption in young adults: A randomised controlled trial pilot
Scientific title
Impact of an online fibre education intervention on fibre consumption in young adults: A randomised controlled trial pilot
Secondary ID [1] 311719 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibre intake 333196 0
Condition category
Condition code
Public Health 329886 329886 0 0
Health promotion/education
Diet and Nutrition 330756 330756 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Four, 1-2 page, evidence-based educational PDF pamphlets, and the text for 12 SMS messages, have been designed by researchers. The pamphlets and text messages provide educational information about types of dietary fibre and the health benefits of dietary fibre consumption.
Participants in the intervention group will be emailed one flier, and texted three messages, per week for one month.

Education resources describing the health benefits of fibre will be sent to participants via text message and email, four times per week, over four weeks.
Intervention code [1] 328183 0
Behaviour
Intervention code [2] 328800 0
Lifestyle
Comparator / control treatment
Passive control (usual care). Control participants will not receive any emails or text messages throughout the study.
Control group
Active

Outcomes
Primary outcome [1] 338516 0
Prospective dietary consumption
Timepoint [1] 338516 0
Baseline (pre-randomisation), one month (post-randomisation), and two months follow-up.
Secondary outcome [1] 432699 0
Anxiety
Timepoint [1] 432699 0
Baseline (pre-randomisation), one month (post-randomisation), and two months follow-up.
Secondary outcome [2] 432700 0
Depression
Timepoint [2] 432700 0
Baseline (pre-randomisation), one month (post-randomisation), and two months follow-up.

Eligibility
Key inclusion criteria
The study will recruit men and women aged 18 years and over who are able to give informed, written consent. All participants must be able to read and write English level proficient enough to understand written instructions and information documented in simple English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any person with a current or previous diagnosis of an eating disorder or condition contraindicating a high fibre diet (i.e. high risk bowel obstruction/ bowel strictures, active Inflammatory Bowel Disease) or cognitive impairment affecting their recall ability will be excluded from the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted block randomisation technique (block size = 10) will be conducted using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
196
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316048 0
University
Name [1] 316048 0
Queensland University of Technology
Country [1] 316048 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 318209 0
None
Name [1] 318209 0
Address [1] 318209 0
Country [1] 318209 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314869 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 314869 0
https://www.qut.edu.au/research/why-qut/ethics-and-integrity
Ethics committee country [1] 314869 0
Australia
Date submitted for ethics approval [1] 314869 0
20/02/2024
Approval date [1] 314869 0
Ethics approval number [1] 314869 0

Summary
Brief summary
The theory of planned behaviour is based on the premise that individuals will formulate plans of action based on the information and knowledge available to them. The study uses this theory to investigate whether the delivery of a one-month educational information package to young adults via email and text message will increase dietary fibre consumption. Dietary surveys delivered before and after the intervention will measure any alterations in dietary behaviour. Surveys relating to mood will evaluate any impacts of fibre intake on anxiety and depression. We hypothesise that increasing awareness of the benefits of dietary fibre consumption via education will lead to improved dietary behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132994 0
Prof Selena Bartlett
Address 132994 0
Level 6, Translational Research Institute, 37 Kent St, Woolloongabba Qld 4102
Country 132994 0
Australia
Phone 132994 0
+61 488990965
Fax 132994 0
Email 132994 0
selena.bartlett@qut.edu.au
Contact person for public queries
Name 132995 0
Kerri Gillespie
Address 132995 0
Level 6, Translational Research Institute, 37 Kent St, Woolloongabba Qld 4102
Country 132995 0
Australia
Phone 132995 0
+61 7 30500830
Fax 132995 0
Email 132995 0
k2.gillespie@hdr.qut.edu.au
Contact person for scientific queries
Name 132996 0
Kerri Gillespie
Address 132996 0
Level 6, Translational Research Institute, 37 Kent St, Woolloongabba Qld 4102
Country 132996 0
Australia
Phone 132996 0
+61 7 30500830
Fax 132996 0
Email 132996 0
k2.gillespie@hdr.qut.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.