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Trial registered on ANZCTR


Registration number
ACTRN12616000274471p
Ethics application status
Not yet submitted
Date submitted
23/02/2016
Date registered
1/03/2016
Date last updated
1/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
STARC Trial: The effects of short term alcohol abstinence on health and wellbeing among non-dependent drinkers
Scientific title
STARC Trial: The effects of short term alcohol abstinence on health and wellbeing among non-dependent drinkers
Secondary ID [1] 288595 0
Nil known
Universal Trial Number (UTN)
U1111-1179-9270
Trial acronym
STARC Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 297739 0
Alcohol abstention 297838 0
Condition category
Condition code
Public Health 297922 297922 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study capitalises on a natural experiment that occurs every year under the Dry July Campaign. Dry July is an annual fundraising event that invites Australians to be alcohol free throughout July in order to raise donations to support adults living with cancer. Registrants seek out sponsors to donate funds in support of their abstinence pledge and the large majority who sign-up honour their obligation. In effect, each year, the Dry July Campaign generates a normative pool of individuals among whom commitment to a brief period of abstinence is facilitated by their pledge and who can be readily accessed for recruitment into a study of the effects of non-dependent alcohol use versus abstinence on health and wellbeing. Our aim is not to evaluate the process (e.g. messaging, delivery) or outcomes of the Dry July Campaign itself rather, we will capitalise on this well established and popular community campaign and apply a randomised controlled trial to investigate the short-term and long-term effects of brief periods of alcohol abstinence on the health and wellbeing of people who usually drink alcohol.

Experimental group participants will be randomly allocated to one of three experimental arms. Arm A will abstain from alcohol for four consecutive weeks in July. Arm B will abstain from alcohol for eight weeks during July and August. Arm C will abstain in July, break in August and abstain for a second 4-week period in September. The study will be functionally divided into baseline and five phases. All participants will be measured at baseline and at the end of each phase.

Compliance with abstinence will be facilitated by their enrolment with the Dry July Campaign. In addition, attrition will be minimised by a combination of strategies including appropriate compensation for participant time, prize draw retention strategy (at the end of Phases 5 and 6), minimisation of participant burden (e.g. flexible data collection times) and repeated follow-up efforts.

To monitor adherence face-to-face detailed surveys will be conducted on alcohol use for all experimental arms and controls. To corroborate self-reported abstinence/alcohol intake among experimental and no-intervention arms phosphatidylethanol will be measured in dried blood spots.
Intervention code [1] 293991 0
Lifestyle
Comparator / control treatment
Arm D will be drawn from the general community and provide a comparable (age, sex and alcohol intake) no-intervention control group.
Control group
Active

Outcomes
Primary outcome [1] 297439 0
Alcohol consumption (self-report):
Face-to-face 30 day timeline follow back questionnaire
Timepoint [1] 297439 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Primary outcome [2] 297440 0
Alcohol consumption (self-report):
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [2] 297440 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Primary outcome [3] 297526 0
Alcohol consumption (clinical):
Phosphatidylethanol alcohol exposure test to corroborate self-reported abstinence/alcohol intake among experimental and no-intervention arms assessed by dried blood spot.
Timepoint [3] 297526 0
4 weeks
8 weeks
12 weeks
Secondary outcome [1] 321314 0
Physical health:
SF-12 Health Survey physical items
Timepoint [1] 321314 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [2] 321315 0
Physical health:
Systolic and diastolic blood pressure
Timepoint [2] 321315 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [3] 321316 0
Physical health:
Adiposity assessed by Body Mass Index and waist-hip ratio
Timepoint [3] 321316 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [4] 321317 0
Physical health:
Lipids (Total cholesterol; High-density lipoprotein cholesterol; Low-density lipoprotein cholesterol; Triglycerides) assessed by serum assay
Timepoint [4] 321317 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [5] 321318 0
Physical health:
Inflamatory markers (C-reactive protein; Fibrinogen) assessed by serum assay
Timepoint [5] 321318 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [6] 321319 0
Physical health:
Liver enzymes (Alanine aminotransferase; Aspartate aminotransferase) assessed by serum assay
Timepoint [6] 321319 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [7] 321320 0
Mental health:
SF-12 Health survey mental items
Timepoint [7] 321320 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [8] 321321 0
Mental health:
Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [8] 321321 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [9] 321322 0
Harms from others’ drinking and behaviour towards others:
US National Alcohol Survey brief harm to others component
Timepoint [9] 321322 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [10] 321323 0
Harms from others’ drinking and behaviour towards others:
Brief Self-control Scale
Timepoint [10] 321323 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [11] 321324 0
Pharma/illicit substance use:
National Drug Strategy Household Survey substance use component modified for 1 month recall
Timepoint [11] 321324 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [12] 321325 0
Sleep quantity:
Assessed by wrist-band monitor/accelerometer
Timepoint [12] 321325 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [13] 321326 0
Sleep quality:
Assessed by wrist-band monitor/accelerometer
Timepoint [13] 321326 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [14] 321327 0
Sleep quality:
Pittsburg Sleep Quality Index
Timepoint [14] 321327 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [15] 321328 0
Daytime sleepiness:
Epworth Sleepiness Scale
Timepoint [15] 321328 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [16] 321329 0
Physical activity level:
Assessed by wrist-band monitor/accelerometer
Timepoint [16] 321329 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence
Secondary outcome [17] 321330 0
Diet:
Dietary Questionnaire for Epidemiological Studies (DQES) on-line V.2
Timepoint [17] 321330 0
Baseline
4 weeks
8 Weeks
12 weeks
3 months post-abstinence
6 months post-abstinence

Eligibility
Key inclusion criteria
(i) English speaking males and females aged 18 years and older resident in the WA metropolitan area and surrounds
(ii) Current but not alcohol-dependent drinkers
(iii) Able to comply with study requirements (e.g., short term abstinence for participants in experimental arms).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Pregnant females and those intending to conceive during the study period
(ii) Smokers (for practical purposes as likely to be small numbers and may be difficult to randomise)
(iii) Non-drinkers
(iv) Drinkers at risk of dependence according to the Alcohol Use Disorders Identification Test (AUDIT > 19)

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)
Allocation concealment of experimental arm participants will be ensured using central randomisation by computer.
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
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 292944 0
Self funded/Unfunded
Name [1] 292944 0
Professor Tanya Chikritzhs
Address [1] 292944 0
National Drug Research Institute
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
WA 6845
Country [1] 292944 0
Australia
Primary sponsor type
Individual
Name
Professor Tanya Chikritzhs
Address
National Drug Research Institute
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
WA 6845
Country
Australia
Secondary sponsor category [1] 291712 0
None
Name [1] 291712 0
None
Address [1] 291712 0
None
Country [1] 291712 0
Other collaborator category [1] 278847 0
Charities/Societies/Foundations
Name [1] 278847 0
Dry July Foundation
Address [1] 278847 0
705/6A Glen St
Milsons Point
NSW 2061
Australia
Country [1] 278847 0
Australia
Other collaborator category [2] 278851 0
Charities/Societies/Foundations
Name [2] 278851 0
Cancer Council Western Australia
Address [2] 278851 0
420 Bagot Road
Subiaco
Perth
WA 6008
Country [2] 278851 0
Australia
Other collaborator category [3] 278852 0
Government body
Name [3] 278852 0
Prevention Services Directorate of the Mental Health Commission
Address [3] 278852 0
GPO Box X2299
Perth Business Centre
Perth
WA 6847
Country [3] 278852 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294449 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 294449 0
GPO Box U1987
Perth
WA 6845
Ethics committee country [1] 294449 0
Australia
Date submitted for ethics approval [1] 294449 0
01/12/2016
Approval date [1] 294449 0
Ethics approval number [1] 294449 0

Summary
Brief summary
Aim:
To investigate the short-term and long-term effects of brief alcohol abstention on behavioural and clinical measures of health and wellbeing among non-dependent drinkers using a randomised controlled trial design under real-world conditions.

Hypotheses:
Short-term change. We hypothesise that:
a) Mean alcohol intake during abstinence pledge periods will be significantly lower compared to usual (baseline) alcohol intake.
b) Compared to usual drinking, four consecutive weeks of abstinence will effect significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, behaviour towards others (BTO) and harms from others’ drinking (HFO), biomarkers for CVD (blood pressure, fats, inflammation) and liver function (enzymes).
c) Compared to usual drinking and four consecutive weeks of abstinence, Eight weeks of consecutive of abstinence will effect significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, BTO, HFO, biomarkers for CVD and liver function.

Long-term change. We hypothesise that:
d) Mean alcohol intake one, three and six months after abstinence pledge periods will be significantly lower compared to baseline alcohol intake, and that these differences may be more pronounced among those with higher levels of alcohol consumption at baseline.
e) There will be significant changes in adiposity, diet, sleep quantity/quality, activity level, mental and physical health, other substance use, behaviour towards others, harms from the drinking of others, biomarkers for cardiovascular disease and liver function, at three and six months follow-up compared to baseline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63750 0
Prof Tanya Chikritzhs
Address 63750 0
National Drug Research Institute
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
WA 6845
Country 63750 0
Australia
Phone 63750 0
+61892661609
Fax 63750 0
Email 63750 0
t.n.chikritzhs@curtin.edu.au
Contact person for public queries
Name 63751 0
Prof Tanya Chikritzhs
Address 63751 0
National Drug Research Institute
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
WA 6845
Country 63751 0
Australia
Phone 63751 0
+61892661609
Fax 63751 0
Email 63751 0
t.n.chikritzhs@curtin.edu.au
Contact person for scientific queries
Name 63752 0
Prof Tanya Chikritzhs
Address 63752 0
National Drug Research Institute
Faculty of Health Sciences
Curtin University
GPO Box U1987
Perth
WA 6845
Country 63752 0
Australia
Phone 63752 0
+61892661609
Fax 63752 0
Email 63752 0
t.n.chikritzhs@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results