Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000251527
Ethics application status
Approved
Date submitted
19/01/2024
Date registered
14/03/2024
Date last updated
14/03/2024
Date data sharing statement initially provided
14/03/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a water intake challenge on beverage intake in Australian adults.
Scientific title
Assessing the effectiveness of a water intake challenge and the validity of a behaviour change readiness index for predicting beverage intake in Australian adults.
Secondary ID [1] 311371 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dehydration 332642 0
Self-efficacy 332643 0
Condition category
Condition code
Diet and Nutrition 329346 329346 0 0
Other diet and nutrition disorders
Public Health 329347 329347 0 0
Other public health
Mental Health 329348 329348 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part 1 of the study involved completing an initial screening survey. Participants were asked to complete a series of questions about their health behaviours (including diet and water intake) and their readiness to change such behaviours. They were also asked several behavioural and psychological measures that formed predictors for participation in the intervention (the second phase of the study). Participants who met the criteria for low daily water intake, namely, <1.2L of water per day based on previous research were invited to participate in the second phase of the study. They were asked to contact the study team to indicate their interest and provide their initials and last 3 digits of their phone number to facilitate data matching. Those who contacted the team were sent a second information sheet and asked to indicate consent via email. Part 1 occurred within a couple of weeks of part 2.

Part 2: Participants that consented to take part in the 4-week health behaviour challenge were asked to increase their water intake to 8 (females) or 10 (males) cups a day. We defined a cup as 250mls. Participants were provided with an online visual tile explaining this challenge aim, which also stated that they could approach this goal any way that worked for them, but to focus on drinking plain water rather than other beverages containing water (e.g., cordial, tea).

Participants used an Ecological Momentary Assessment (EMA) smartphone application to record their water and other beverage intake once daily as well as their mood twice daily. No other direct contact was made with the participants over the four weeks, other than to respond to enquiries and to send links to complete follow-up surveys (i.e., start of challenge, week 2, week 4).

A key outcome of the study involved validating the CSIRO behaviour change readiness index, which comprised psychological and experiential predictors of initial interest and committed intention to change a health behaviour, as well as behaviour change success. This will be done by assessing the utility of the index for predicting successful short-term behaviour change outcomes in the dietary domain (i.e., water drinking), but also to better understand the associations and strengths of relevant factors to refine this tool into a succinct survey. Thus, the study focused on predicting behavioural outcomes rather than improving health behaviours. The validation of the index involved participants from part 1 of the study.
Intervention code [1] 327813 0
Behaviour
Intervention code [2] 327814 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337166 0
Beverage intake, namely, average daily consumption of plain drinking water
Timepoint [1] 337166 0
Screening and Week 4 (end of treatment)
Secondary outcome [1] 430921 0
Coping self-efficacy
Timepoint [1] 430921 0
Baseline and Week 4 (end of treatment)
Secondary outcome [2] 430923 0
Habit
Timepoint [2] 430923 0
Baseline and Week 4 (end of treatment)
Secondary outcome [3] 430924 0
Daily hassles/uplifts
Timepoint [3] 430924 0
Baseline and Week 4 (end of treatment)
Secondary outcome [4] 430925 0
Dysexecutive function
Timepoint [4] 430925 0
Baseline and Week 4 (end of treatment)
Secondary outcome [5] 430926 0
Self-regulatory failure
Timepoint [5] 430926 0
Baseline, Week 2 (mid-point) and Week 4 (end of treatment)
Secondary outcome [6] 430927 0
Behavioural self-efficacy
Timepoint [6] 430927 0
Baseline and Week 4 (end of treatment)
Secondary outcome [7] 430928 0
Behavioural intention
Timepoint [7] 430928 0
Baseline and Week 4 (end of treatment)
Secondary outcome [8] 430929 0
Stress
Timepoint [8] 430929 0
Baseline, Week 2 (mid-point) and Week 4 (end of treatment)
Secondary outcome [9] 430930 0
Emotional energy
Timepoint [9] 430930 0
Baseline, Week 2 (mid-point) and Week 4 (end of treatment)
Secondary outcome [10] 430935 0
Vitality
Timepoint [10] 430935 0
Screening, Week 2 (mid-point) and Week 4 (end of treatment)
Secondary outcome [11] 430936 0
Mood
Timepoint [11] 430936 0
Screening, Week 2 (mid-point) and Week 4 (end of treatment)
Secondary outcome [12] 430937 0
Self-Evaluation and feedback
Timepoint [12] 430937 0
Week 2 (mid-point)
Secondary outcome [13] 430938 0
Stage of change
Timepoint [13] 430938 0
Screening and Week 4 (end of treatment)
Secondary outcome [14] 430939 0
Subjective wellbeing
Timepoint [14] 430939 0
Screening and Week 4 (end of treatment)
Secondary outcome [15] 432211 0
Daily mood and beverage intake
Timepoint [15] 432211 0
Daily from baseline to week 4 (end of treatment)

Eligibility
Key inclusion criteria
Part 1: Initial screening survey
• 18 years or older
• Perceived good comprehension of English.
Part 2: 4-week intervention
• Completed initial screening survey
• Met following screening criteria based on survey responses: <1.2L daily water consumption
• Willing to provide informed consent
• Access to own smartphone and willing to download a free application from app store
• Access to own email address/service
• Minimum iOS 12.0 and Android 5.0 to assess the study app.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Any self-reported condition that includes a medical fluid restriction e.g. chronic kidney disease. To be confirmed prior to consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Predicting different stages of behavioural engagement using outcomes collected in the initial screening survey requires a large sample to achieve sufficient statistical power. The three stages are: Committed intention (signing up when eligible), Behavioural uptake (starting behaviour change intervention) and Early Success (successfully changing behaviour). Factor analysis was performed using Maximum Likelihood estimation and Promax rotation, extraction was based on Eigenvalue. Our primary analysis general linear models examining differences between stages in psychological and behavioural resources.

To ensure enough participants make it to the final part 2 of our study, we required 835 people to start the screening survey (part 1). Thus, the target sample size for part 2 was n=200 (i.e., the number of people who commenced the intervention).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
10/11/2022
Date of last participant enrolment
Anticipated
Actual
10/11/2022
Date of last data collection
Anticipated
Actual
9/12/2022
Sample size
Target
200
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315630 0
Other
Name [1] 315630 0
CSIRO
Country [1] 315630 0
Australia
Primary sponsor type
Other
Name
CSIRO
Address
Gate 13, Kintore Avenue, Adelaide, South Australia
Country
Australia
Secondary sponsor category [1] 317729 0
None
Name [1] 317729 0
None
Address [1] 317729 0
None
Country [1] 317729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314514 0
The CSIRO Health and Medical Human Research Ethics committee (low risk review panel)
Ethics committee address [1] 314514 0
Ethics committee country [1] 314514 0
Australia
Date submitted for ethics approval [1] 314514 0
05/10/2022
Approval date [1] 314514 0
24/10/2022
Ethics approval number [1] 314514 0
2022_063_LR

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

Contacts
Principal investigator
Name 131854 0
Dr Emily Brindal
Address 131854 0
CSIRO, Gate 13, Kintore Avenue, Adelaide, South Australia, 5000
Country 131854 0
Australia
Phone 131854 0
+61 8 83050633
Fax 131854 0
Email 131854 0
[email protected]
Contact person for public queries
Name 131855 0
Emily Brindal
Address 131855 0
CSIRO, Gate 13, Kintore Avenue, Adelaide, South Australia, 5000
Country 131855 0
Australia
Phone 131855 0
+61 8 83050633
Fax 131855 0
Email 131855 0
[email protected]
Contact person for scientific queries
Name 131856 0
Emily Brindal
Address 131856 0
CSIRO, Gate 13, Kintore Avenue, Adelaide, South Australia, 5000
Country 131856 0
Australia
Phone 131856 0
+61 8 83050633
Fax 131856 0
Email 131856 0
[email protected]

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.