Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001005741
Ethics application status
Approved
Date submitted
9/09/2013
Date registered
10/09/2013
Date last updated
10/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Breakfast consumption: Temporal Self-Regulation Theory and Implementation Intentions
Scientific title
Reducing breakfast skipping in healthy Australian young adults using an Implementation Intention planning intervention: a Randomised Controlled Trial
Secondary ID [1] 283170 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 290028 0
Poor mood 290029 0
Poor nutrition 290030 0
Condition category
Condition code
Diet and Nutrition 290407 290407 0 0
Obesity
Diet and Nutrition 290408 290408 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the implementation intention group will complete an computer based implementation intention task that involves the generation of If-Then plans to overcome barriers to breakfast consumption (e.g. ‘If I wake up late on a weekday, then I will eat a tub of yoghurt for breakfast while waiting for the bus!’).

Participants will be asked to complete the planning task at the conclusion of the online survey. The task instructions are as follows: ‘We want you to plan to eat breakfast every day during the next week, paying particular attention to the situations in which you will implement these plans. You could choose to focus on planning what breakfast foods to buy, how you will prepare them or something more specific. For example, you may find it useful to state: “If I wake up late on a weekday, then I will eat a tub of yoghurt for breakfast while waiting for the bus!” Please write your plans in the space provided, following the format in the example (“if?…?then …”)’.

Follow-up data collection will occur one week after the baseline survey.
Intervention code [1] 287898 0
Prevention
Intervention code [2] 287899 0
Behaviour
Intervention code [3] 287900 0
Lifestyle
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 290433 0
Self-reported breakfast eating frequency
Timepoint [1] 290433 0
1 week
Secondary outcome [1] 304511 0
Intention to consume breakfast will be assessed using a 3 item self-report scale.

This measure has been used in previous studies of breakfast eating frequency (Kothe, E. J., Mullan, B. A., & Amaratunga, R. (2011). Randomised controlled trial of a brief theory-based intervention promoting breakfast consumption. Appetite.56 (1) 148-155)
Timepoint [1] 304511 0
1 week

Eligibility
Key inclusion criteria
18-25 years of age
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Participants are automatically randomised using a random number generator when completing the survey and online intervention components.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are automatically randomised using simple randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287922 0
Self funded/Unfunded
Name [1] 287922 0
Nil
Country [1] 287922 0
Primary sponsor type
University
Name
Deakin University
Address
Deakin University
221 Burwood Highway
Burwood
VIC
3125
Country
Australia
Secondary sponsor category [1] 286650 0
None
Name [1] 286650 0
N/A
Address [1] 286650 0
N/A
Country [1] 286650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289853 0
Faculty of Health Low Risk Ethics Committee - Deakin University
Ethics committee address [1] 289853 0
Ethics committee country [1] 289853 0
Australia
Date submitted for ethics approval [1] 289853 0
Approval date [1] 289853 0
Ethics approval number [1] 289853 0

Summary
Brief summary
The role of temporal self-regulation theory variables and implementation intentions in breakfast consumption will be investigated in a sample of healthy individuals from the community. Participants who join the study will be randomised to one of two groups (1) implementation intention group (2) no implementation intention group. All tasks will be completed online.

All participants will complete a baseline assessment that measures perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), frequency of breakfast consumption in the past week, and relevant demographic variables (e.g. age and gender).

Participants in the implementation intention group will also complete an implementation intention task that involves the generation of If-Then plans to overcome barriers to breakfast consumption (e.g. ‘If I wake up late on a weekday, then I will eat a tub of yoghurt for breakfast while waiting for the bus!’).

At one week post-baseline all participants will be emailed an invitation to complete the follow-up assessment. This assessment will reassesses perceptions of the environment as supportive or unsupportive (CAS), intention to consume breakfast, planning ability (Tower of London), response inhibition (Stroop), habit strength (Self-Report Habit Index), and frequency of breakfast consumption in the past week.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42782 0
Dr Emily Kothe
Address 42782 0
School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125
Country 42782 0
Australia
Phone 42782 0
61433356819
Fax 42782 0
Email 42782 0
[email protected]
Contact person for public queries
Name 42783 0
Dr Emily Kothe
Address 42783 0
School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125
Country 42783 0
Australia
Phone 42783 0
61433356819
Fax 42783 0
Email 42783 0
[email protected]
Contact person for scientific queries
Name 42784 0
Dr Emily Kothe
Address 42784 0
School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125
Country 42784 0
Australia
Phone 42784 0
61433356819
Fax 42784 0
Email 42784 0
[email protected]

No information has been provided regarding IPD availability


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.