Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001222639
Ethics application status
Not yet submitted
Date submitted
7/11/2014
Date registered
19/11/2014
Date last updated
19/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the relationship between mindfulness and self-control related to fruit and vegetable consumption in young adults.
Scientific title
"The effect of Mindfulness Training on Trait Self-control and the Intention-Behaviour Relationship in the Theory of Planned Behaviour" in university students, as assessed by daily fruit and vegetable intake (behaviour outcome).
Secondary ID [1] 285610 0
None
Universal Trial Number (UTN)
U1111-1163-8259
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293460 0
Diabetes 293501 0
Condition category
Condition code
Diet and Nutrition 293740 293740 0 0
Obesity
Public Health 293780 293780 0 0
Health promotion/education
Mental Health 293781 293781 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 4-week behaviour intervention (BI) group designed to increase fruit and vegetable intake in young adults, compared to a combined 4-week behaviour intervention with mindfulness training (BIM) group. Both programs will take place in a classroom setting with one teacher and the group.

The behaviour intervention (BI) program will be developed specifically for this study and will comprise of 4 weekly 1-hour meetings over a one month period, consisting of the following topics:
a) Week 1: Information on health and behaviour and negative consequences of having an unhealthy diet.
b) Week 2: Information on other’s behaviour, seeking approval, and social comparisons.
c) Week 3: Motivation and instruction on how to successfully perform the behaviour.
d) Week 4: Tips on overcoming hindrances and issues opposing the desired behaviour.

The Behaviour Intervention and Mindfulness Group (BIM) will consist of the standard behaviour intervention (see above as presented to the BI group), with additional training and set homework exercises in mindfulness to be practiced on a daily basis over the four week period of the BIM intervention.

These components are based on the mindfulness practices from the 8-week MBSR program, which will be condensed for this purpose into a four week intervention:
a) Week 1: 40 min Body Scan Exercise and 10 min mindful eating activity
b) Week 2: 15-20 min Sitting meditation, mindfulness in daily activities instructions
c) Week 3: 20-30 min Sitting meditation, mindfulness in daily activities, 10 min walking meditation
d) Week 4: 30-40 min Sitting meditation, walking meditation, and mindfulness in daily activities.

The homework exercises in mindfulness will consist of a daily 20-30 min sitting or walking meditation practice, with ad-hoc practice of mindfulness in daily activities when suitable. A weekly record will be recorded of time/practice during the four-week program. In total, about 3-5 hours of mindfulness meditation practice per week as homework will be expected of participants in the BIM group.

The Fruit and Vegetable Consumption questionnaire will be completed on a daily basis by the participants over the four week period for both the BI and BIM intervention programs to monitor behaviour outcome.
Intervention code [1] 290566 0
Behaviour
Comparator / control treatment
The standard behaviour intervention group is the comparator/ control group.
Control group
Active

Outcomes
Primary outcome [1] 293541 0
Daily Fruit and vegetable consumption as assessed by a daily food diary indicating daily servings of fruit and vegetables consumed, measured in serving size.
Timepoint [1] 293541 0
4 weeks
Secondary outcome [1] 311297 0
Trait Self-control assessed by the Self-Control Scale (SCS), a 36-item self-report scale designed to assess trait self-control, developed by Tangney, Baumeister and Boone (2004).
Timepoint [1] 311297 0
4 weeks
Secondary outcome [2] 311298 0
Levels of Mindfulness assessed by the Mindfulness Attention Awareness Scale (MAAS), a 15-item self-report scale designed to assess level of mindfulness, developed by Brown and Ryan (2003).
Timepoint [2] 311298 0
4 weeks

Eligibility
Key inclusion criteria
Students enrolled at Curtin University.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A psychiatric condition or history of substance abuse. Any personal reasons (spiritual or otherwise) for not wanting to learn meditation.

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)
Participants will be screened for substance use and psychiatric conditions, or personal objections to learning meditation, by completing a control screening questionnaire. A pre-screening question will be included to ensure participants are naive to meditation practice prior to commencing the study. Participants will be randomly allocated to one of two intervention groups (behaviour intervention or combined behaviour intervention + mindfulness training). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study will be a between-groups pre-post design.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Structural Equation Modelling (SEM).

In order to reliably test the SEM, it has been recommended that we have at least 10 participants for each free parameter* in the model - although 20 participants per free parameter is the ideal (Kline, 2005).

Therefore, a minimum sample size for testing this SEM model is 10[6 + 3 +1] =100 (50 in each group).

*A free parameter is a parameter that must be estimated from the sample data. The free parameters in this SEM model include the path coefficients (6 parameters), the disturbances of the endogenous variable (3 parameter), and the variances of the exogenous variables (1 parameter).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/02/2015
Actual
Date of last participant enrolment
Anticipated
9/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8879 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 290209 0
University
Name [1] 290209 0
Curtin University
Country [1] 290209 0
Australia
Primary sponsor type
University
Name
Curtin University, School of Psychology and Speech Pathology
Address
Building 401
Kent Street, Bentley, Perth WA 6102
Country
Australia
Secondary sponsor category [1] 288916 0
None
Name [1] 288916 0
Address [1] 288916 0
Country [1] 288916 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291916 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 291916 0
Ethics committee country [1] 291916 0
Australia
Date submitted for ethics approval [1] 291916 0
10/11/2014
Approval date [1] 291916 0
Ethics approval number [1] 291916 0

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

Contacts
Principal investigator
Name 52578 0
Ms Anne Murphy
Address 52578 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 52578 0
Australia
Phone 52578 0
+61 8 9266 3050
Fax 52578 0
Email 52578 0
[email protected]
Contact person for public queries
Name 52579 0
Rosanna Rooney
Address 52579 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 52579 0
Australia
Phone 52579 0
+61 8 9266 3050
Fax 52579 0
Email 52579 0
[email protected]
Contact person for scientific queries
Name 52580 0
Barbara Mullan
Address 52580 0
School of Psychology and Speech Pathology
Curtin University
GPO Box U1987
Perth Western Australia 6845
Country 52580 0
Australia
Phone 52580 0
+61 8 9266 2468
Fax 52580 0
Email 52580 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.