ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Poor mood

Poor nutrition

Condition category

Condition code

Diet and Nutrition

Obesity

Diet and Nutrition

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

No treatment

Control group

Active

Outcomes

Primary outcome [1]

Self-reported breakfast eating frequency

Timepoint [1]

1 week

Secondary outcome [1]

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]

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]

Self funded/Unfunded

Name [1]

Nil

Address [1]

Nil

Country [1]

Primary sponsor type

University

Name

Deakin University

Address

Deakin University
221 Burwood Highway
Burwood
VIC
3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Faculty of Health Low Risk Ethics Committee - Deakin University

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Dr Emily Kothe

Address

School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125

Country

Australia

Phone

61433356819

Fax

emily.kothe@deakin.edu.au

Contact person for public queries

Name

Emily Kothe

Address

School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125

Country

Australia

Phone

61433356819

Fax

emily.kothe@deakin.edu.au

Contact person for scientific queries

Name

Emily Kothe

Address

School of Psychology
221 Burwood Highway
Deakin University
Burwood Campus
Burwood
VIC 3125

Country

Australia

Phone

61433356819

Fax

emily.kothe@deakin.edu.au

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.

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