Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001337460
Ethics application status
Approved
Date submitted
16/09/2016
Date registered
26/09/2016
Date last updated
22/01/2019
Date data sharing statement initially provided
18/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can relaxation reduce unhealthy eating in response to stress?
Scientific title
The effect of guided relaxation on appetite and energy intake: implications for stress-induced eating, weight management and cardiovascular disease
Secondary ID [1] 290144 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 300263 0
weight gain 300278 0
Condition category
Condition code
Diet and Nutrition 300130 300130 0 0
Obesity
Mental Health 300182 300182 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will complete an 8 week program of guided relaxation. This will be comprised of progressive muscular relaxation and a mindfulness-based meditation practice. This will consist of one face-to-face group session per week (no more than 30 min in duration) and unsupervised regular daily practice (20 min per day). The intervention will be administered by an Accredited Practicing Dietitian and Yoga and Meditation Teacher (RYT-500hr+). Adherence to required frequency of relaxation practice will be monitored through recording attendance to group sessions, and the maintenance of a home-practice diary.
Intervention code [1] 295898 0
Lifestyle
Intervention code [2] 295934 0
Behaviour
Comparator / control treatment
The control participants will continue their normal routine throughout the 8 week intervention period (i.e. no treatment will be given). All participants will complete pre- and post-intervention assessments eight weeks apart.
Control group
Active

Outcomes
Primary outcome [1] 299618 0
Ad libitum energy intake of a laboratory test meal.
Timepoint [1] 299618 0
At baseline (week 0) and post-intervention (week 8).
Secondary outcome [1] 327780 0
Sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [1] 327780 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [2] 327830 0
trait anxiety - State-Trait Anxiety Inventory (STAI-trait)
Timepoint [2] 327830 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [3] 327831 0
life stress - Perceived Stress Scale (PSS)
Timepoint [3] 327831 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [4] 327832 0
mindfulness - Mindfulness Attention Awareness Scale (MAAS)
Timepoint [4] 327832 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [5] 327833 0
rumination - Rumination Resposne Scale (RRS)
Timepoint [5] 327833 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [6] 327834 0
eating behaviour - Dutch Eating Behaviour Questionnaire (DEBQ) and Three Factor eating Questionnaire (TFEQ)
Timepoint [6] 327834 0
At baseline (week 0) and post-intervention (week 8)
Secondary outcome [7] 327835 0
self-reported measures of appetite - Visual Analogue Scale
Timepoint [7] 327835 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, 90 min, and 120min
Secondary outcome [8] 327836 0
self reported measures of mood - Profile of Mood States (POMS)
Timepoint [8] 327836 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, 90 min, and 120min
Secondary outcome [9] 327837 0
heart rate - measured by a digital heart rate monitor
Timepoint [9] 327837 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, 90 min, and 120min
Secondary outcome [10] 327839 0
blood pressure
Timepoint [10] 327839 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, 90 min, and 120min
Secondary outcome [11] 327840 0
salivary cortisol
Timepoint [11] 327840 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, and 90 min
Secondary outcome [12] 327841 0
appetite-related peptides: plasma insulin, plasma acylated ghrelin, and plasma leptin
Timepoint [12] 327841 0
During the pre-intervention laboratory session and the post-intervention laboratory session, at baseline (time 0), 30 min, 60 min, and 90 min.
Secondary outcome [13] 327937 0
BMI
Timepoint [13] 327937 0
Pre-intervention (week 0) and post intervention (week 8)
Secondary outcome [14] 327938 0
Waist-hip circumference
Timepoint [14] 327938 0
Pre-intervention (week 0) and post intervention (week 8)

Eligibility
Key inclusion criteria
Participants will be males and females aged 18 – 60 years with a BMI = 20-29kg/m2 and weight stable.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not have any diagnosed medical conditions, a history of substance abuse, use prescription medications, or engage in smoking or heavy drinking. They should not be dieting, have a previous regular practice of relaxation techniques, engage in excessive exercise (greater than two hours/day), or have an irregular work/sleep schedule.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, this will be achieved through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
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
A sample size of at least 17 participants in each group is required to detect a difference of 500 kJ in ad libitum energy intake with a power of 0.8 based on work by Gregerson et al 2008. Repeated measures ANOVA with between group comparisons will be used to determine the effect of the relaxation intervention on the outcome variables of interest pre- and post-intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2016
Actual
14/10/2016
Date of last participant enrolment
Anticipated
1/03/2017
Actual
3/07/2017
Date of last data collection
Anticipated
1/05/2017
Actual
13/09/2017
Sample size
Target
50
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294515 0
University
Name [1] 294515 0
The University of Western Australia
Country [1] 294515 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway Crawley, Western Australia 6009
Country
Australia
Secondary sponsor category [1] 293388 0
None
Name [1] 293388 0
Address [1] 293388 0
Country [1] 293388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295954 0
Research Ethics and Biosafety Office, The University of Western Australia
Ethics committee address [1] 295954 0
Ethics committee country [1] 295954 0
Australia
Date submitted for ethics approval [1] 295954 0
10/09/2013
Approval date [1] 295954 0
30/10/2013
Ethics approval number [1] 295954 0
RA/4/1/6429

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

Contacts
Principal investigator
Name 69022 0
Ms Tasmiah Masih
Address 69022 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway Crawley WA 6009
Country 69022 0
Australia
Phone 69022 0
+61 421 130 222
Fax 69022 0
+61 8 6488 1039
Email 69022 0
[email protected]
Contact person for public queries
Name 69023 0
Tasmiah Masih
Address 69023 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway Crawley WA 6009
Country 69023 0
Australia
Phone 69023 0
+61 421 130 222
Fax 69023 0
+61 8 6488 1039
Email 69023 0
[email protected]
Contact person for scientific queries
Name 69024 0
Tasmiah Masih
Address 69024 0
School of Human Sciences (Exercise and Sport Science)
University of Western Australia
35 Stirling Highway Crawley WA 6009
Country 69024 0
Australia
Phone 69024 0
+61 421 130 222
Fax 69024 0
+61 8 6488 1039
Email 69024 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
At this stage, data will be available if this is a requirement of the journals publishing the research papers, which are still to be published.


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.